CN108078654A - The manufacturing method of intraocular lens and the intraocular lens using this method manufacture - Google Patents
The manufacturing method of intraocular lens and the intraocular lens using this method manufacture Download PDFInfo
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- CN108078654A CN108078654A CN201710635558.0A CN201710635558A CN108078654A CN 108078654 A CN108078654 A CN 108078654A CN 201710635558 A CN201710635558 A CN 201710635558A CN 108078654 A CN108078654 A CN 108078654A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
- A61F2/1637—Correcting aberrations caused by inhomogeneities; correcting intrinsic aberrations, e.g. of the cornea, of the surface of the natural lens, aspheric, cylindrical, toric lenses
- A61F2/164—Aspheric lenses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0053—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in optical properties
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- Health & Medical Sciences (AREA)
- Ophthalmology & Optometry (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Manufacturing method the present invention relates to intraocular lens and the intraocular lens using this method manufacture.The intraocular lens is implanted in anterior chamber or the back room of the human eye with natural lens, to change the refractive status of human eye.The intraocular lens includes opticator, support section and in the coupling part being connected with support section of opticator periphery.Opticator includes front surface and rear surface, at least one including aspherical in front surface and rear surface.The intraocular lens is made of the material for being capable of water swelling after hydration.The intraocular lens of the present invention is processed under dry state or uses by injection molding and after hydration.The manufacturing method of the present invention considers the expansion characteristics of material in the fabrication process, passes through the trial-manufacturing process of Approach by inchmeal, it is ensured that intraocular lens obtained after water swelling expected from optical property.
Description
Technical field
Manufacturing method the present invention relates to intraocular lens and the intraocular lens using this method manufacture.
Background technology
Crystal eye intraocular lens is that one kind is implanted to human eye's anterior chamber or back room（Between cornea and natural lens）, use
It is general with negative diopter to change the intraocular lens of the refractive status of human eye, for correcting myopia, particularly correct high
Degree myopia.Also there is minority with positive diopter, for correcting long sight.
There is crystal eye intraocular lens according to implantation position and fixed form, Intraocular lens and posterior chamber type can be divided into.Posterior chamber type
Intraocular lens has the effect of determining since postoperative complications are few, is current most mainstream.This intraocular lens is implanted to
Between natural lens and iris, there is template button loop or similar flat button loop, be supported in ciliary groove.Due to intraocular lens with
Position relationship between human ocular tissues' structure closely, is easily in contact with human ocular tissues' structure, such as ciliary groove tissue, therefore
And to the soft and moist property of material, i.e. the softness of material, degree of lubrication is more demanding, in order to avoid material rubs, human ocular tissues surface is drawn
Play inflammation and complication.Therefore it is such to have crystal eye intraocular lens to carry certain water content, with higher soft and moist
The acrylate materials of property are advisable.For example the ICL of STAAR companies production is that water wetted material is made, water content 34%.It is this kind of
It is processed with intraocular lens made of the acrylate materials of water content under dry state or by injection molding, treats people
Work crystalline lens is suctioned after moisture is fully hydrated, and last use is presented in size, optical property etc. for intraocular lens's expansion
State.
The prior art has the disadvantage that：
（1）It is existing that have crystal eye intraocular lens be spherical design
The implantation environment of crystal eye intraocular lens is the human eye of structural integrity, preferably has crystal eye intraocular lens should not
Additional aberration, particularly spherical aberration are introduced to human eye, otherwise will cause the side such as optical quality decline, poor contrast, Night Glare
The problem of face.Existing to have crystal eye intraocular lens be spherical design, human eye can be given to introduce all kinds of aberrations after implantation, especially
It is spherical aberration.Those skilled in the art it is generally known that, the intraocular lens with positive diopter will introduce positive spherical aberration to human eye, with negative
The intraocular lens of diopter will introduce negative spherical aberration to human eye, and the diopter of intraocular lens is stronger, and the amount of spherical aberration of introducing is bigger,
It is more serious to the interference of visual quality.
Such as the ICL of existing STAAR companies production, it is declared according to its market propaganda data, by the way that " progressive refractive index becomes
Change " realizations " spherical face but have aspherical effect ", purpose is exactly to want to bring to reduce spherical design by material property
Spherical aberration influence, improve visual quality.But the preparation process of material itself is extremely complex, it is difficult to accomplish the amplitude of variation, become
Change the accurate control of uniformity etc..Thus the spherical aberration control of actual product is unsatisfactory.Clinically common dazzle shows ICL
As this substantial amounts of spherical aberration that human eye may be introduced into it is inseparable.
（2）Existing aspheric design method is not suitable for having crystal eye intraocular lens made of water wetted material
This characteristic of the water swelling of water wetted material gives the aspheric design for having crystal eye intraocular lens to bring new difficult point, this
It is because significant changes can occur for face shape of the intraocular lens after water swelling made of water wetted material, causes intraocular implants
Significant changes occur for the size and optical property of body, deviate desired design value.
In conclusion existing, to have crystal eye intraocular lens be all spherical design, and human eye can be given to introduce a large amount of spherical aberrations, and
Existing aspheric design technology is not suitable for the intraocular lens design with certain water content or even can come with negative picture
Difference interference.
The generally Chinese middle-aged adults that crystal eye intraocular lens corrects eye refractive status are implanted with, they are to vision matter
That measures is more demanding, and the intraocular lens's diopter being typically implanted is larger, and spherical surface intraocular implants made of water wetted material know from experience
Very serious vision puzzlement is brought to patient.
The content of the invention
An aspect of of the present present invention provides a kind of manufacturing method of intraocular lens, and the intraocular lens is implanted to tool
Have in anterior chamber or the back room of the human eye of natural lens, to change the refractive status of human eye, the intraocular lens includes light
The department of the Chinese Academy of Sciences point, support section and in the coupling part being connected with support section of opticator periphery, the opticator includes
Front surface and rear surface, it is at least one including aspherical in the front surface and the rear surface, the intraocular lens by
The material for being capable of water swelling after hydration is made, and the manufacturing method includes the following steps：
（a）Determine the target component of desired realization after the abundant water swelling of the intraocular lens；
（b）Intermediate parameters before intraocular lens's water swelling are determined according to the target component, and according in described
Between parameter determine the structural parameters of the intraocular lens；
（c）The material manufacture intraocular lens before water swelling is utilized according to structural parameters；
（d）Make the abundant water swelling of intraocular lens；
（e）Intraocular lens after abundant water swelling is detected, obtains the manually lenticular actual parameter；
（f）By actual parameter compared with the target component；
（g）If the difference between actual parameter and the target component adjusts ginseng among described beyond predetermined threshold range
It counts to obtain adjusted intermediate parameters and determine the structure of the intraocular lens according to the adjusted intermediate parameters
Parameter, if difference between actual parameter and the target component without departing from predetermined threshold range, will be manufactured artificial
Crystalline lens is as final intraocular lens；And
（h）If the difference between actual parameter and the target component exceeds predetermined threshold range, repeatedly step（c）-
（g）.
In one embodiment, the expression formula of the aspherical curve on two-dimensional coordinate system plane rZ is：
Wherein, R is the radius of curvature of the aspherical basic spherical surface, and r is any point on the curve away from axis of abscissas Z's
Vertical range, A2iFor aspherical high order term coefficient, m, n are the integer and n not less than 1>M, Q are asphericity coefficient,
Wherein, each point in the aspherical face shape carries out rotational symmetry variation by the curve negotiating around axis of abscissas Z
And obtain, and
Wherein, the radius of curvature of structural parameters including the front surface, radius of curvature of the rear surface, described aspherical
Coefficient and the aspherical high order term coefficient.
In one embodiment, the step（b）In the knot that the intraocular lens is determined according to the intermediate parameters
Structure parameter includes determining the radius of curvature of the front surface, radius of curvature of the rear surface, described according to the intermediate parameters
Asphericity coefficient and the aspherical high order term coefficient；And wherein, the step（c）Water suction is being utilized according to structural parameters
The material manufacture intraocular lens before expansion further includes before：
By the radius of curvature divided by k of identified front surface,
By the radius of curvature of identified rear surface divided by k and
By identified aspherical high order term coefficient A2iIt is multiplied by respectively,
Wherein, k is the coefficient of expansion of the material.
In one embodiment, the target component includes target refraction degree and/or target spherical aberration, the intermediate parameters bag
Intermediate diopter and/or intermediate spherical aberration are included, wherein, the target refraction degree is desired after the abundant water swelling of intraocular lens
The diopter of realization, the target spherical aberration are the spherical aberrations of desired realization after the abundant water swelling of intraocular lens, the centre
Diopter is the diopter before intraocular lens's water swelling, and the intermediate spherical aberration is the ball before intraocular lens's water swelling
Difference.
In one embodiment, the target spherical aberration is zero.
In one embodiment, the target refraction degree is 0 to -30.0D, it is therefore preferable to which -3.0D arrives -25.0D.
In one embodiment, step（b）In intraocular lens's water swelling is determined according to the target component
Preceding intermediate parameters include：The intermediate diopter is determined as being equal to target refraction degree and/or determines the intermediate spherical aberration
To be equal to target spherical aberration.
In one embodiment, step（b）In intraocular lens's water swelling is determined according to the target component
Preceding intermediate parameters include：In being determined as value more more negative than the target refraction degree by the intermediate diopter and/or will be described
Between spherical aberration be determined as than the target spherical aberration corrigendum value.
In one embodiment, step（g）In the adjustment intermediate parameters include：The intermediate diopter is adjusted to
Value more more negative than the target refraction degree and/or the value for being adjusted to correct than the target spherical aberration by the intermediate spherical aberration.
In one embodiment, the material is acrylate materials, the coefficient of expansion between 1.01 to 1.615,
Preferably between 1.01 to 1.29, more preferably between 1.04 to 1.20.
In one embodiment, the material is acrylate materials, and refractive index is between 1.38 to 1.55, preferably
Ground is between 1.44 to 1.53, more preferably between 1.48 to 1.51.
In one embodiment, the material is acrylate materials, and water content is excellent between 3.5% to 74.5%
Selection of land is between 6% to 38%, more preferably between 8% to 20%.
In one embodiment, the overall diameter of the intraocular lens preferably exists between 11.0 mm to 14.5 mm
Between 11.5 mm to 14.2 mm, more preferably between 11.8 mm to 13.9 mm.
In one embodiment, the diameter of the opticator is more than or equal to 4.2 mm, preferably in 4.5 mm to 6.5
Between mm, more preferably between 5.0 mm to 6.0 mm.
In one embodiment, the opticator and the coupling part collectively constitute the main body of intraocular lens, institute
The diameter of main body is stated between 5.5 mm to 8.0 mm, preferably between 6.0 mm to 7.5 mm, more preferably in 6.2 mm
To between 7.0 mm.
In one embodiment, the center thickness of the intraocular lens preferably exists between 0.05 mm to 0.50mm
Between 0.08 mm to 0.20mm, more preferably between 0.10 mm to 0.15mm.
In one embodiment, the vault height of the intraocular lens preferably exists between 1.00 mm to 1.80mm
Between 1.10 mm to 1.60mm, more preferably between 1.20 mm to 1.50mm.
Another aspect of the present invention additionally provides the intraocular lens manufactured by above-mentioned manufacturing method.
Description of the drawings
Fig. 1 a show the floor map of the intraocular lens of the present invention.
Fig. 1 b show the cross-sectional view of the intraocular lens of the present invention.
Fig. 2 show made of the material for being capable of water swelling after hydration intraocular lens before water swelling and
The schematic diagram of face deformation afterwards.
Fig. 3 shows the flow chart of one embodiment of manufacturing method according to the invention.
Fig. 4 shows the flow chart of another embodiment of manufacturing method according to the invention.
Fig. 5 is manufacturing method using the present invention and has crystal eye intraocular lens to be implanted to using common manufacturing methods
MTF after same standard human-eye model.
Fig. 6 is manufacturing method using the present invention and has crystal eye intraocular lens to be implanted to using common manufacturing methods
Seidel aberration profile figures after same standard human-eye model.
Specific embodiment
Specific examples below is only intended to the present invention be further explained explanation, but the present invention does not limit to
In following specific embodiment.Any variation on the basis of these embodiments, as long as meeting the spirit of the present invention
And scope, it falls in protection scope of the present invention.
The present invention relates to a kind of manufacturing method of intraocular lens, which is implanted to natural lens
Human eye anterior chamber or back room in, to change the refractive status of human eye.As shown in Figure 1a, intraocular lens of the invention includes
Opticator 1, support section 2 and in the coupling part 3 being connected with support section of opticator periphery.Opticator 1 wraps
Include front surface and rear surface.It is at least one including aspherical in front surface and rear surface.The present invention intraocular lens by
The material for being capable of water swelling after hydration is made.
Fig. 2 show made of the material for being capable of water swelling after hydration intraocular lens before water swelling and
The schematic diagram of face deformation afterwards.Although Fig. 2 is by taking opticator is the intraocular lens of flat-recessed structure as an example, shown in Fig. 2
Principle be suitable for the intraocular lens that opticator is other structures, such as double-concave structure, male-female structure etc..In fig. 2,
Solid line is the sectional view of opticator of the intraocular lens before water swelling.Since intraocular lens is water wetted material system
Into volume will expand intraocular lens after absorbing water, and degrees of expansion can be described by " coefficient of expansion " k, be referred to
The variation of size before and after expansion, including the variation on length, thickness direction.Using O in scheming as origin, it is assumed that intraocular implants
Point A coordinates are on body surface face（H, d）, after the abundant water swelling of intraocular lens, A points are expanded to A ', then the coordinate of A ' is（H ',
d’）, and h '=k × h, d '=k × d.
If intraocular lens is spherical design, the optical surface profile of spherical surface meets formula：
（1）
Wherein z（r）For curve representation formula of the spherical surface on two-dimensional coordinate system plane rZ, R is the radius of curvature of the spherical surface,
R is vertical range of any point away from axis of abscissas Z on the curve, and each point on the spherical surface shape is by the curve negotiating
Rotational symmetry variation is carried out around axis of abscissas Z and is obtained.
The coordinate of A points meets formula：
（2）
With the coordinate of the coordinate representation A of A ' after expansion, obtain：
（3）
Above formula simplification can be obtained：
（4）
As it can be seen that the coordinate of A '（H ', d '）Also the optical surface profile expression formula of spherical surface is met, simply radius of curvature is become from original R
R’=Rk.It follows that the intraocular lens of spherical surface, after abundant water swelling, surface is still spherical surface, simply radius of curvature hair
Variation is given birth to, as coefficient of expansion k ＞ 1, the radius of curvature after water swelling becomes much larger.If it is intended to realize intraocular lens
Desired diopter is realized after abundant water swelling, then needs to be adjusted radius of curvature.
However, in order to realize the purpose of correction aberration, if being by the front surface of intraocular lens and/or back surface design
Aspherical, situation will become complicated.In optical design, the even aspheric surface General Expression for correcting aberration is：
（5）
Wherein Z（r）For the aspherical curve representation formula on two-dimensional coordinate system plane rZ, R is the aspherical basis
Sphere curvature radius, r are vertical range of any point away from axis of abscissas Z on the curve, A2iFor aspherical high order term coefficient,
M, n is the integer and n not less than 1>M, Q are asphericity coefficient；Each point on the aspheric surface is by the curve negotiating
Rotational symmetry variation is carried out around axis of abscissas Z and is obtained.
According to different design requirements, these coefficients can be 0, can not also be 0.
Equally with A（H, d）、A’（H ', d '）Coordinate calculate the relation of point before and after expansion on aspherical
It can obtain：
（6）
As it can be seen that the intraocular lens of aspheric design, after abundant water swelling, aspherical is no longer simple radius of curvature
Variation, it is but also related with aspherical high order term coefficient, and each not phase of the ratio of each aspherical high-order term index variation
Together.
Aspheric intraocular lens mainly pass through formula to the correction of aberration（6）In even term coefficient reach, these evens
Term coefficient has just and has negative, is mutually matched the purpose for reaching all kinds of aberration corrections.Intraocular lens is not due to made of water wetted material
With the interference of the level coefficient of expansion, two kinds of counter productives are brought to aspheric design：
（1）Reduce aspherical spherical aberration correction ability；
（2）Additional higher order aberratons are brought, cause aberration disorderly.
By taking Q values are 0 aspheric design as an example, aspherical expression formula is still shown in formula（5）, Q values are 0, then before even order terms
Expression formula characterizes a spherical surface, and subsequent even order terms are used for the face shape difference for making aspherical generation different from spherical surface, correct aberration.
When intraocular lens has negative diopter, if it is desired to reach the correction of aberration, realize the purpose of 0 spherical aberration, then even order terms
Characterization is an offset born in height, makes intraocular lens thinner when neighboring area is than spherical surface.Work as intraocular implants
After body material has water suction speciality and the coefficient of expansion, by formula（6）As it can be seen that as k ＞ 1, the offset born in height can reduce, from
And reduce the neighboring area degree thinner than spherical surface, reduce aspherical spherical aberration correction ability.Meanwhile the matching between even order terms by
In the level of different k, cause to match unbalance, bring additional higher order aberratons.
In the present invention, by comparing with target component the actual parameter after the abundant water swelling of intraocular lens
Compared with, one or many trial-production is repeated, makes artificial lenticular actual parameter Approach by inchmeal target component, it is finally definite non-
The structural parameters of spherical surface intraocular lens so that carried according to the intraocular lens that the structural parameters manufacture after abundant water swelling
For desired optical property.
In one embodiment, as shown in figure 3, the manufacturing method of the present invention includes the following steps（a）-（h）.
In step（a）In, determine the target component of desired realization after the abundant water swelling of intraocular lens.Herein,
Target component can include any parameter of desired realization after the abundant water swelling of intraocular lens.For example, target component can
To include target refraction degree and/or target spherical aberration, wherein, target refraction degree is desired after the abundant water swelling of intraocular lens
The diopter of realization, and target spherical aberration is the spherical aberration of desired realization after the abundant water swelling of intraocular lens.
In some embodiments, target spherical aberration is zero.
In some embodiments, target refraction degree is 0 to -30.0D, it is therefore preferable to which -3.0D arrives -25.0D.
In step（b）In, the intermediate parameters before intraocular lens's water swelling are determined according to target component, and in
Between parameter determine the structural parameters of intraocular lens.Herein, intermediate parameters can include intermediate diopter and/or intermediate
Difference, wherein, intermediate diopter is the diopter before intraocular lens's water swelling, and intermediate spherical aberration is intraocular lens's water suction
Spherical aberration before expansion.Herein, structural parameters may include but be not limited to the radius of curvature of the front surface of intraocular lens, artificial crystalline substance
The radius of curvature of the rear surface of shape body, the aspherical asphericity coefficient of intraocular lens and intraocular lens it is aspherical
Aspherical high order term coefficient.Optical design software, such as the structure ginseng of the definite intraocular lens of Zemax, CODE V may be employed
Number.
In step（c）In, utilize the material manufacture intraocular lens before water swelling according to structural parameters.
In step（d）In, make the abundant water swelling of intraocular lens.In some embodiments, balanced salt solution pair is passed through
Intraocular lens is hydrated, and makes its abundant water swelling.In further embodiments, by BSS solution to intraocular lens
It is hydrated, makes its abundant water swelling.In further embodiments, by the solution close with aqueous humor ingredient to intraocular implants
Body is hydrated, and makes its abundant water swelling.
Hydration time can be determined by the factors such as thickness of the material moisture content of intraocular lens, intraocular lens.Manually
During lens, when its size, weight, shape no longer change, it is considered having reached abundant hydration or fills
Divide water swelling.In some embodiments, hydration time is 2 days.When in further embodiments, hydration time can be 2 small,
4 it is small when, 8 it is small when etc..
In step（e）In, the intraocular lens after abundant water swelling is detected, obtains the manually lenticular reality
Border parameter.Herein, actual parameter refers to actually measured with target component pair after the abundant water swelling of intraocular lens
Actually measured diopter and/or intraocular lens fully absorb water after the parameter answered, such as the abundant water swelling of intraocular lens
Actually measured spherical aberration after expansion.The intraocular lens after abundant water swelling can be examined using optical detection apparatus
It surveys, such as the spherical aberration and/or diopter of detection intraocular lens, and record numerical value.
In step（f）In, by actual parameter compared with target component.
In step（g）In, if the difference between actual parameter and target component exceeds predetermined threshold range, it is believed that this
The intraocular lens of manufacture is not carried out desired target component, then adjusts intermediate parameters to obtain adjusted intermediate parameters simultaneously
And the structural parameters of intraocular lens are determined according to adjusted intermediate parameters；If the difference between actual parameter and target component
It is different without departing from predetermined threshold range, it is believed that this manufacture intraocular lens have been realized in desired target component, then by institute
The intraocular lens of manufacture is as final intraocular lens.
In step（h）In, if the difference between actual parameter and target component is repeated beyond predetermined threshold range
State step（c）-（g）.
In some embodiments, step（b）In the centre before intraocular lens's water swelling is determined according to target component
Parameter includes：Intermediate diopter is determined as being equal to target refraction degree and/or is determined as intermediate spherical aberration to be equal to target spherical aberration.
The aspherical expression formula of intraocular lens is shown in formula（5）, the coefficient of expansion of artificial crystalline lens material is k.By formula（5）Extremely
Formula（6）Derivation understand, intraocular lens is before and after abundant water swelling, the structural parameters of intraocular lens（For example,
Aspherical basic sphere curvature radius, asphericity coefficient and aspherical high order term coefficient）There are proportionate relationship, such as 1 institute of table
Show.
Table 1
| Before expansion | R | Q | A2 | A4 | A6 | … | A2i |
| After expansion | Rk | Q | A2/k | A4/k3 | A6/k5 | … | A2i/k2i-1 |
As it can be seen from table 1 the aspherical basic sphere curvature radius R of intraocular lens is that water suction is swollen after water swelling
K times before swollen, the asphericity coefficient Q of intraocular lens is remained unchanged before and after water swelling, and intraocular implants
The aspherical high order term coefficient A of body2i1/k before being water swelling after water swelling2i-1Times.
Based on above-mentioned analysis, the present invention is innovatively proposed in the shadow for designing with the coefficient of expansion being considered in manufacturing process
It rings and according to table 2 to the structural parameters of intraocular lens（For example, basic sphere curvature radius, asphericity coefficient and aspheric
Face high order term coefficient）It is pre-adjusted, so that the intraocular lens after water swelling has desired structural parameters.Tool
It is right according to table 2 after the structural parameters of intraocular lens are determined according to target component using optical design software for body
The structural parameters of intraocular lens are pre-adjusted, so that intraocular lens's " variation " after water swelling arrives and it is expected
Structural parameters.
Table 2
| Before adjustment | R | Q | A2 | A4 | A6 | … | A2i |
| After adjustment | R/k | Q | A2k | A4k3 | A6k5 | … | A2ik2i-1 |
As can be seen that when the structural parameters to intraocular lens pre-adjust, aspherical basic sphere curvature radius R
Multiplying factor for 1/k, and aspherical high order term coefficient A2、A4、A6、……A2iMultiplying factor be respectively k,、
、…….Since the asphericity coefficient Q of intraocular lens is remained unchanged before and after water swelling, there is no need to
Adjustment.
Carry out the aspherical expression formula of the intraocular lens after above-mentioned adjustment：
（7）
Correspondingly, in some embodiments, as shown in figure 4, step（b）In the knot that intraocular lens is determined according to intermediate parameters
Structure parameter includes determining the radius of curvature of front surface, the radius of curvature of rear surface, asphericity coefficient and non-according to intermediate parameters
Spherical surface high order term coefficient, and step（c）According to structural parameters using the material manufacture intraocular lens before water swelling it
Before further include according to the coefficient of expansion of material adjust structural parameters, wherein, according to the coefficient of expansion of material adjust structural parameters bag
It includes：By the radius of curvature divided by k of identified front surface, by the radius of curvature of identified rear surface divided by k and by really
Fixed aspherical high order term coefficient A2iIt is multiplied by respectively, wherein, k is the coefficient of expansion of the material.
According to the present invention, the structural parameters in intraocular lens are passed through（Such as radius of curvature, the song of rear surface of front surface
Rate radius, asphericity coefficient and aspherical high order term coefficient）Middle collocation and the coefficient of expansion are relevant, multiple of different proportion because
Son using the manufacturing method of Approach by inchmeal, makes intraocular lenses, diopter meet target, eliminates what the coefficient of expansion was brought
It influences.
From derivation above it is recognised that water swelling can make manually lenticular aspherical spherical aberration modification drop
Low, i.e., the aspherical face deformationization brought is not big enough, for the correct amount deficiency of negative spherical aberration, therefore is more likely to make in design
Intraocular lens provide spherical aberration just more, so as to improve the aspherical face shape variable quantity brought, and then make up water swelling
The reduction of spherical aberration modification amount afterwards.
It is worth noting that, the change that the radius of curvature that intraocular lens's water swelling is brought as previously described becomes larger
Change, in process, correct diopter is turned radius of curvature to a certain degree down, it is necessary to adjust processing program in order to obtain
Afterwards（Also i.e. by intraocular lens design into before water swelling have more negative diopter）, could be obtained after abundant water swelling
Obtain desired diopter.And the degree turned down depend on intraocular lens's material the coefficient of expansion and theoretical radius of curvature it is big
Small, the coefficient of expansion is bigger, and adjustment amount is bigger；Radius of curvature is bigger in itself, and adjustment amount is bigger.In order to exclude the shadow of mismachining tolerance
It rings, trial-production multi-disc is averaged as final spherical aberration measurement result.Finally, the intraocular lens of acquisition should be in diopter, aberration
Aspect meets expected design requirement.
Correspondingly, in some embodiments, step（b）In intraocular lens's water swelling is determined according to target component before
Intermediate parameters include：Intermediate diopter is determined as value more more negative than target refraction degree and/or is determined as comparing by intermediate spherical aberration
The value of target spherical aberration corrigendum.
Correspondingly, in some embodiments, step（g）In adjustment intermediate parameters include：Intermediate diopter is adjusted to
Value more more negative than target refraction degree and/or the value for being adjusted to correct than target spherical aberration by intermediate spherical aberration.
Embodiment 1 to 8 schematically illustrates some specific embodiments of the present invention.The present invention is by the expansion characteristics of material
It is added in aspherical design and the manufacturing process of intraocular lens, using the trial-manufacturing process of Approach by inchmeal, makes intraocular implants
Body can obtain desired spherical aberration and/or diopter after abundant water swelling.In an arrangement, filled by intraocular lens
The actual parameter detected after water swelling is divided to be compared with target component, aspheric design is determined, eliminates the influence of the coefficient of expansion；
In another further preferred scheme, arrange in pairs or groups in the structural parameters of intraocular lens relevant from the coefficient of expansion, different
The multiplying factor of ratio eliminates the influence of the coefficient of expansion.
Embodiment 1
Refractive Index of Material is 1.502, the coefficient of expansion 1.04, and target component is -15.0D and zero spherical aberration.That is, target is bent
Luminosity is -15.0D, and target spherical aberration is 0.
The aspheric design of intraocular lens's opticator is carried out using optical design software Zemax, designs intraocular implants
Body front surface is spherical surface, and rear surface is aspherical, using intraocular lens when clear aperature is as 5.0mm, the spherical aberration in water be 0 and
Diopter is that -15.0D is intermediate parameters（Spherical aberration is 0 among i.e., and intermediate diopter is -15.0D）It is designed, obtains artificial crystalline substance
The structural parameters of shape body, as shown in table 3.
Table 3
| Spherical aberration | Ra | Rp | Q | A4 | A6 | A8 |
| 0.00λ | -48.70 | 14.22 | 1.122 | -1.1186e-04 | -5.015e-07 | -1.345e-09 |
Wherein, Ra, Rp are respectively the radius of curvature on forward and backward surface, unit mm.Q is asphericity coefficient, A4、A6、A8To be aspherical
High order term coefficient.
Processing drawing is made according to structural parameters, using numerically controlled lathe, using refractive index, the coefficient of expansion is for 1.502
1.04 acrylate material carries out aspheric intraocular lens trial-production.
The intraocular lens that trial-production obtains is put into balanced salt solution, impregnates two days, makes artificial lens, is fully inhaled
It is taken out after water expansion.
Using optical detector, the detection of the actual parameter of the intraocular lens after being hydrated, observe spherical aberration size or
Diopter distribution curve, and record numerical value.After testing, the average actual ball of more pieces of intraocular lenses of first trial-production gained is found
Difference is -0.12 λ, and 0 spherical aberration with it is expected to realize differs greatly.Diopter testing result shows, the artificial lenticular reality of gained
Diopter is -13.8D, and the target refraction degree of -15.0D with it is expected to realize differs greatly.
For bearing the intraocular lens of the number of degrees, the spherical aberration carried is negative spherical aberration, therefore " 0 spherical aberration " design provided for the first time
Its essence is that additional positive spherical aberration is provided for intraocular lens by aspherical, is reconciled with the negative spherical aberration of crystalline lens in itself.
This trial result, intraocular lens still show negative spherical aberration, illustrate the reconciliation dynamics of positive spherical aberration of aspherical offer not
Foot, therefore the dynamics of aspheric surface interference should be increased in the design, intermediate spherical aberration is tuned up to positive value, that is to say, that will be manually brilliant
Shape body is designed to the spherical aberration before water swelling with bigger.
Meanwhile diopter is not reaching to expected requirement, detected value shows that diopter is inadequate, so as to need intermediate diopter
It is adjusted to value more more negative than target refraction degree, that is, by intraocular lens design into having more negative dioptric before water swelling
Degree also turns radius of curvature down.
Intermediate spherical aberration is adjusted to when clear aperature is 5.0mm, the spherical aberration in water is+0.1 λ, is designed after optimization
Parameter, as shown in table 4.
Table 4
| Spherical aberration | Ra | Rp | Q | A4 | A6 | A8 |
| +0.1λ | -45.0 | 14.01 | -1.588 | -7.317e-05 | -1.285e-06 | -2.932e-08 |
Wherein, λ represents a wavelength, such as using 550nm wavelength during design, then+0.1 λ of spherical aberration represent spherical aberration size for+
0.055μm。
Repeat above-mentioned processing, hydration, detection process, final detection find gained manually lenticular spherical aberration for -0.01 λ=-
0.0055 μm of 0 μm of ≈, diopter are -14.90D, and judgement meets target component.
In the manufacturing process of the present invention, if the diopter measured after the abundant water swelling of manufactured intraocular lens
Difference between target refraction degree is without departing from the ball measured after predetermined threshold range and/or the abundant water swelling of intraocular lens
Difference between difference and target spherical aberration then judges that manufactured intraocular lens meets target ginseng without departing from predetermined threshold range
Number.
The predetermined threshold range of the diopter of intraocular lens can determine according to the requirement of professional standard, such as
Diopter criterion of acceptability specified in YY0290, ISO11979.Actually measured diopter is controlled to be bent with target when being typically designed
The difference of luminosity is without departing from the tolerance of professional standard.In addition, in some embodiments, the predetermined threshold range of diopter can also
Be set as the certain percentage of target refraction degree, for example, be set as target refraction degree ± 10%, ± 8%, ± 6%, ± 4%, ± 2%,
± 1%, ± 0.5%, etc..The predetermined threshold range of the spherical aberration of intraocular lens can be determined by the requirement of designer.It for example, can
To think to control the difference of actually measured spherical aberration and target spherical aberration within ± 0.05 λ.In addition, in some embodiments
In, can by μm in units of set the predetermined threshold range of spherical aberration, for example, it can be set to for ± 0.05 μm, ± 0.1 μm etc..Separately
Outside, in some embodiments, the predetermined threshold range of spherical aberration can also be set as the certain percentage of target spherical aberration, such as set
± 10%, ± 8%, ± 6%, ± 4%, ± 2%, ± 1%, ± 0.5%, etc. for target spherical aberration.
In the present embodiment, the intraocular lens of requirement is met by manufacturing experimently twice, it is made substantially to realize 0 ball
The target component of difference and -15.0D diopters.If manufacturing experimently the intraocular lens that could not be met the requirements for the second time, need
Above-mentioned steps are iteratively repeated, the intraocular lens of 0 spherical aberration and -15.0D diopters can be realized until drawing.
In a further mode of operation, structural parameters are adjusted using the coefficient of expansion in the fabrication process.
The aspheric design of intraocular lens's opticator is carried out using optical design software Zemax, designs intraocular implants
For body front surface to be aspherical, rear surface is spherical surface, using intraocular lens when clear aperature is as 5.0mm, the spherical aberration in water be 0 and
Diopter is that -15.0D is intermediate parameters（Spherical aberration is 0 among i.e., and intermediate diopter is -15.0D）It is designed, obtains structure ginseng
Number, as shown in table 5.
Table 5
| Spherical aberration | Ra | Rp | Q | A4 | A6 | A8 |
| 0.00λ | -48.049 | 14.22 | -0.6398 | 6.224e-05 | -2.933e-07 | 3.140e-08 |
According to material expand coefficient 1.04, the structural parameters of the intraocular lens shown in table 5 are carried out according to the processing mode of table 2
Adjustment, obtains adjusted structural parameters, as shown in table 6.
Table 6
| Ra | Rp | Q | A4 | A6 | A8 |
| -46.20 | 13.67 | -0.6398 | 7.001E-05 | -3.568E-07 | 4.132E-08 |
Structural parameters according to table 6 make processing drawing, using numerically controlled lathe, use refractive index as 1.502, the coefficient of expansion
For 1.04 acrylate material, aspheric intraocular lens trial-production is carried out.
Intraocular lens is put into balanced salt solution, is impregnated two days, is made artificial lens, taken after abundant water swelling
Go out.
Using optical detector, the detection of intraocular lens's actual parameter after being hydrated is observed spherical aberration size or is bent
Light distribution curve, and record numerical value.After testing, the average value of the diopter of more pieces of intraocular lenses is -15.12D.For mesh
For mark diopter is -15.0D, diopter tolerance specified in professional standard（Namely predetermined threshold range）It is ± 0.3D, it can
To think that the diopter meets the requirements.After testing, spherical aberration is -0.06 λ, close to -0.1 λ, it is believed that the still negative ball of a residual part
Difference.
As described previously for the intraocular lens of the negative number of degrees, the spherical aberration carried is negative spherical aberration, therefore " 0 provided for the first time
It is that additional positive spherical aberration is provided for intraocular lens by aspherical that spherical aberration ", which designs its essence, with the negative spherical aberration of crystalline lens in itself
It is reconciled.This trial result, intraocular lens still show negative spherical aberration speciality, illustrate the positive spherical aberration of aspherical offer
Reconciliation dynamics deficiency, therefore the dynamics of aspheric surface interference should be increased in the design, intermediate spherical aberration is tuned up to positive value, that is,
It says intraocular lens design into the spherical aberration with bigger before water swelling.
Intermediate spherical aberration is adjusted to when clear aperature is 5.0mm, the spherical aberration in water is+0.1 λ, obtains structural parameters, such as
Shown in table 7.
Table 7
| Spherical aberration | Ra | Rp | Q | A4 | A6 | A8 |
| +0.1λ | -48.049 | 14.22 | -418.516 | -2.72E-04 | 2.92E-05 | -8.74E-07 |
According to material expand coefficient 1.04, the structural parameters of intraocular lens are adjusted according to the processing mode of table 2, are obtained
Adjusted structural parameters, as shown in table 8.
Table 8
| Ra | Rp | Q | A4 | A6 | A8 |
| -46.20 | 13.67 | -418.516 | -3.060E-04 | 3.549E-05 | -1.150E-06 |
It repeats the above steps, is machined, be hydrated, detected, the diopter for finally obtaining more pieces of intraocular lenses is averaged
It is worth for -15.04D, the average value of spherical aberration is 0 μm of 0.03 λ ≈, and judgement has reached target component.
The target component of embodiment 2-8, material therefor are different, but implementation process is similar to Example 1, only lists pass below
Key step and implementation information.
Embodiment 2
Refractive Index of Material is 1.458, the coefficient of expansion 1.13, and target component is -25.0D and zero spherical aberration.That is, target is bent
Luminosity is -25.0D, and target spherical aberration is 0.
Structural parameters are adjusted using the coefficient of expansion in the fabrication process.
Intermediate diopter is set as -25.0D, and intermediate difference is respectively set as 0 ,+0.1 λ ,+0.2 λ ,+0.25
λ obtains the structural parameters of intraocular lens, as shown in table 9, wherein, intraocular implants' body front surface is spherical surface, and rear surface is aspheric
Face.
Table 9
| Intraocular lens's sequence number | Intermediate spherical aberration | Ra | Rp | Q | A4 | A6 | A8 |
| 1 | 0 | -15.00 | 7.02 | 1.943 | -1.267e-03 | -1.242e-05 | -3.825e-06 |
| 2 | +0.1λ | -15.00 | 7.00 | 1.479 | -1.209e-03 | -1.660e-05 | -1.886e-06 |
| 3 | +0.2λ | -15.00 | 7.00 | 1.448 | -1.212e-03 | -1.908e-05 | -1.965e-06 |
| 4 | +0.25λ | -15.00 | 7.00 | 1.418 | -1.348e-03 | -2.009e-05 | -2.006e-06 |
According to material expand coefficient 1.13, the structural parameters of the intraocular lens shown in table 9 are carried out according to the processing mode of table 2
Adjustment, obtains adjusted structural parameters, as shown in table 10.
Table 10
| Intraocular lens's sequence number | Ra | Rp | Q | A4 | A6 | A8 |
| 1 | -13.27 | 6.21 | 1.943 | -1.828E-03 | -2.288E-05 | -8.999E-06 |
| 2 | -13.27 | 6.19 | 1.479 | -1.744E-03 | -3.058E-05 | -4.437E-06 |
| 3 | -13.27 | 6.19 | 1.448 | -1.749E-03 | -3.515E-05 | -4.623E-06 |
| 4 | -13.27 | 6.19 | 1.418 | -1.945E-03 | -3.701E-05 | -4.719E-06 |
It is hydrated after examination processing, carries out the spherical aberration in 5.0mm apertures and diopter detection, the results are shown in Table 11, confirm No. 1 intraocular lens
For final result.
Table 11
| Intraocular lens's sequence number | 1 | 2 | 3 | 4 |
| Actual spherical aberration | +0.04λ | +0.17λ | +0.23λ | +0.39λ |
| Actual refraction degree | -25.11D | -24.93D | -24.85D | -25.07D |
It can be seen that from the implementation process of the embodiment in the case where being adjusted using the coefficient of expansion to structural parameters,
Since the coefficient of expansion was just intervened in the design phase, therefore the actual parameter of the intraocular lens obtained by actual processing is joined with target
Number deviation is smaller.In most cases, ideal result just can be obtained by the trial-production of 1-2 times.On rare occasion,
For example material expand coefficient is larger, the calibration of the larger or lathe of deformation in itself is bad, and the trial-production unstable grade of environment is, it is necessary to more
Secondary trial-production excludes sorts of systems, design error, obtains final design.
Embodiment 3-8 is equally in the fabrication process adjusted structural parameters using the coefficient of expansion.
Embodiment 3
Refractive Index of Material is 1.453, the coefficient of expansion 1.17, and target component is -5.0D and zero spherical aberration.That is, target is bent
Luminosity is -5.0D, and target spherical aberration is 0.
Intermediate diopter is set as -5.0D, and intermediate spherical aberration is set as 0, obtains the structure ginseng of intraocular lens
Number, as shown in table 12, wherein, the rear surface of the aspherical opticator positioned at intraocular lens.
Table 12
| Spherical aberration | Ra | Rp | Q | A4 | A6 | A8 |
| 0.00 | -100.00 | 30.55 | -0.723 | -2.592e-06 | 1.075e-06 | -8.536e-08 |
According to material expand coefficient 1.17, according to table 2 processing mode to the structural parameters of the intraocular lens shown in table 12 into
Row adjustment, obtains adjusted structural parameters, as shown in table 13.
Table 13
| Ra | Rp | Q | A4 | A6 | A8 |
| -85.47 | 26.11 | -0.723 | -4.151E-06 | 2.357E-06 | -2.562E-07 |
After examination processing hydration, the spherical aberration in 5.0mm apertures and diopter detection, the spherical aberration average value of more pieces of intraocular lenses are carried out
For -0.01 λ, diopter average value is -5.22D, and it is final result to confirm the intraocular lens.
Embodiment 4
Refractive Index of Material is 1.453, the coefficient of expansion 1.17, and target component is -5.0D and -0.2 λ spherical aberrations.That is, target
Diopter is -5.0D, and target spherical aberration is -0.2 λ.
Intermediate diopter is set as -5.0D, and intermediate spherical aberration is set as -0.2 λ, obtains the knot of intraocular lens
Structure parameter, as shown in table 14, wherein, the rear surface of the opticator of intraocular lens is aspherical.
Table 14
| Spherical aberration | Ra | Rp | Q | A4 | A6 | A8 |
| -0.2λ | -100.00 | 30.55 | 46.009 | 1.095e-04 | -5.011e-06 | -3.673e-07 |
According to material expand coefficient 1.17, according to table 2 processing mode to the structural parameters of the intraocular lens shown in table 14 into
Row adjustment, obtains adjusted structural parameters, as shown in Table 15.
Table 15
| Ra | Rp | Q | A4 | A6 | A8 |
| -85.47 | 26.11 | 46.009 | 1.754E-04 | -1.099E-05 | -1.102E-06 |
After examination processing hydration, the spherical aberration and diopter detection, the spherical aberration measured that carry out 5.0mm apertures are -0.22 λ, and diopter is put down
Average is -5.13D, and it is final result to confirm the intraocular lens.
Embodiment 5
Refractive Index of Material is 1.502, the coefficient of expansion 1.04, and target component is -5.0D and+0.2 λ spherical aberrations.That is, target
Diopter is -5.0D, and target spherical aberration is+0.2 λ.
Intermediate diopter is set as -5.0D, and intermediate spherical aberration is set as+0.2 λ, obtains the knot of intraocular lens
Structure parameter, as shown in table 16, wherein, the rear surface of the opticator of intraocular lens is aspherical.
Table 16
| Spherical aberration | Ra | Rp | Q | A4 | A6 | A8 |
| +0.2λ | -100.00 | 30.55 | 18.267 | -3.500e-04 | -5.670e-06 | -3.016e-07 |
According to material expand coefficient 1.04, according to table 2 processing mode to the structural parameters of the intraocular lens shown in table 16 into
Row adjustment, obtains adjusted structural parameters, as shown in table 17.
Table 17
| Ra | Rp | Q | A4 | A6 | A8 |
| -96.15 | 29.38 | 18.267 | -3.937E-04 | -6.898E-06 | -3.969E-07 |
After examination processing hydration, the spherical aberration and diopter detection, the spherical aberration measured that carry out 5.0mm apertures are+0.19 λ, and diopter is put down
Average is -5.15D, and it is final result to confirm the intraocular lens.
Embodiment 6
Refractive Index of Material is 1.375, the coefficient of expansion 1.615, and target component is -3.0D and zero spherical aberration.That is, target is bent
Luminosity is -3.0D, and target spherical aberration is 0.
Intermediate diopter is set as -3.0D, and intermediate spherical aberration is set as 0, obtains the structure ginseng of intraocular lens
Number, wherein, the rear surface of the opticator of intraocular lens is aspherical.After initial structure parameter and utilization coefficient of expansion adjustment
Structural parameters be shown in Table 18.
Table 18
| Type | Ra | Rp | Q | A4 | A6 | A8 |
| Initially | -100 | 14.94 | -0.186 | -6.873e-06 | -3.339e-06 | 1.370e-07 |
| After adjustment | -61.92 | 9.25 | -0.186 | -2.895E-05 | -3.668E-05 | 3.926E-06 |
After trial-production, hydration, diopter is carried out to sample using optical detector and spherical aberration detects, finds more pieces of intraocular lenses
Diopter average value for -3.72D, spherical aberration average value is -0.12 λ, it is seen that is differed greatly with target component.This is because expansion
Coefficient has reached 1.615, and the excessive coefficient of expansion causes influence of the coefficient of expansion of design phase intervention to asphericity coefficient
It is multiplied, affects the accuracy of final result.
In this case it is necessary to it is adjusted.It can be seen from the results above that regulating measures should include reducing dioptric
Degree improves spherical aberration intervention amount.According to this as a result, intermediate diopter is set as -2.5D, and intermediate difference is respectively set as
+ 0.1 λ ,+0.15 λ ,+0.2 λ, obtain the structural parameters of intraocular lens, as shown in table 19.
Table 19
| Sequence number | Spherical aberration | Ra | Rp | Q | A4 | A6 | A8 |
| 1 | +0.1λ | -61.92 | 9.50 | -26.681 | 3.069e-03 | -2.570e-04 | 7.036e-06 |
| 2 | +0.15λ | -61.92 | 9.50 | -19.773 | 1.882e-03 | -1.680e-04 | 4.175e-06 |
| 3 | +0.2λ | -61.92 | 9.50 | -16.357 | 1.302e-03 | -1.270e-04 | 2.880e-06 |
Machine drawing drafting, processing, hydration are carried out to the intraocular lens design of table 19, detected using optical detector, detection knot
Fruit is shown in Table 20.
Table 20
| Intraocular lens's sequence number | 1 | 2 | 3 |
| Spherical aberration detected value | -0.07λ | -0.01λ | 0.06λ |
Think the spherical aberration of No. 2 intraocular lenses closest to the target component of 0 spherical aberration, No. 2 intraocular lens's diopter average values for-
2.98D determines that it is final design.
Embodiment 7
Refractive Index of Material is 1.438, the coefficient of expansion 1.20, and target component is -10.0D and zero spherical aberration.That is, target is bent
Luminosity is -10.0D, and target spherical aberration is 0.
Intermediate diopter is set as -10.0D, and intermediate spherical aberration is set as 0, obtains the structure ginseng of intraocular lens
Number, wherein, the rear surface of the opticator of intraocular lens is aspherical.After initial structure parameter and utilization coefficient of expansion adjustment
Structural parameters be shown in Table 21.
Table 21
| Type | Ra | Rp | Q | A4 | A6 | A8 |
| Initially | -100 | 11.30 | -0.233 | -8.329e-05 | 4.691e-06 | -3.814e-07 |
| After adjustment | -83.33 | 9.42 | -0.233 | -1.439E-04 | 1.167E-05 | -1.367E-06 |
After drawing by machine drawing, process, being hydrated, it is detected using optics instrument, the spherical aberration average value of more pieces of intraocular lenses
For -0.03 λ, diopter average value is -9.84D, is determined as final result.
Embodiment 8
Refractive Index of Material is 1.530, the coefficient of expansion 1.01, and target component is -30.0D and zero spherical aberration.That is, target is bent
Luminosity is -30.0D, and target spherical aberration is 0.
Intermediate diopter is set as -30.0D, and intermediate spherical aberration is set as 0, obtains the structure ginseng of intraocular lens
Number, wherein, the rear surface of the opticator of intraocular lens is aspherical.After initial structure parameter and utilization coefficient of expansion adjustment
Structural parameters be shown in Table 22.
Table 22
| Type | Ra | Rp | Q | A4 | A6 | A8 |
| Initially | -30.00 | 8.15 | 3.059 | -9.973e-04 | -1.191e-05 | -3.471e-06 |
| After adjustment | -29.70 | 8.07 | 3.059 | -1.028E-03 | -1.252E-05 | -3.721E-06 |
After drawing by machine drawing, process, being hydrated, it is detected using optics instrument, the spherical aberration average value of more pieces of intraocular lenses
For -0.01 λ, diopter average value is -30.16D, is determined as final result.
In the above-described embodiments, the aspherical of some embodiments is located at intraocular implants' body front surface, other embodiments
Aspherical to be located at intraocular lens's rear surface, aspherical high order term coefficient generally uses A4、A6、A8Combination.The present invention is conceived
, in some embodiments, the forward and backward surface of intraocular lens can be all using aspherical.Institute of the invention it is contemplated that
In some embodiments, A can be used simultaneously2、A10、A12、A14It is combined etc. aspherical high order term coefficient, and with Q values.
In the above-described embodiments, by both the target component selected as diopter of intraocular lens and spherical aberration.In other realities
It applies in example, can be selected by the target component selected as diopter of intraocular lens or by the target component of intraocular lens
For spherical aberration.
The predetermined spherical aberration of intraocular lens is determined by purpose of usage.In some embodiments, the object ball of intraocular lens
Difference is positive value, and in further embodiments, the target spherical aberration of intraocular lens is negative value.For having crystal eye intraocular lens's
Using, it is preferable that the target spherical aberration of intraocular lens is 0.Those skilled in the art it is generally known that, it is detection aperture, solution environmental, preceding
Put or postposition optical element etc. can state spherical aberration value and impact, spherical aberration design load with detected value under different conditions
There may be different statements, all without departing from the design of the present invention.
Table 23 is some embodiments of adoptable material, and the material is esters of acrylic acid, is suitble to ophthalmology implantation, has
Good spectral transmittance performance, after hydration flexible folding.
22 Refractive Index of Material of table, water content and coefficient of expansion embodiment
| Sequence number | Refractive index（20 DEG C of hygrometric state） | Water content（20℃） | Coefficient of expansion k（20℃） |
| 1 | 1.406 | 50% | 1.29 |
| 2 | 1.385 | 65% | 1.45 |
| 3 | 1.375 | 74% | 1.615 |
| 4 | 1.417 | 50% | 1.28 |
| 5 | 1.400 | 60% | 1.36 |
| 6 | 1.402 | 59% | 1.38 |
| 7 | 1.405 | 58% | 1.37 |
| 8 | 1.390 | 67% | 1.49 |
| 9 | 1.375 | 74.5% | 1.61 |
| 10 | 1.438 | 38% | 1.20 |
| 11 | 1.407 | 55% | 1.35 |
| 12 | 1.458 | 26% | 1.13 |
| 13 | 1.502 | 8% | 1.04 |
| 14 | 1.453 | 34% | 1.17 |
| 15 | 1.530 | 4% | 1.01 |
As shown in Figure 1a, intraocular lens according to the present invention includes opticator 1 and support section 2.Intraocular lens with
Human ocular tissues' structure size matches, overall diameter 4 between 11.0mm to 14.5mm, preferably 11.5mm to 14.2mm it
Between, more preferably between 11.8mm to 13.9mm.The opticator of intraocular lens is located at intraocular lens center, is artificial
Crystalline lens realizes the core position of dioptric function, and at some, manually lenticular 1 periphery of opticator has and 2 phase of support section
Coupling part 3 even.The diameter of the opticator 1 of intraocular lens is more than or equal to 4.2mm, it is preferable that the light of intraocular lens
The diameter of the department of the Chinese Academy of Sciences point 1 is between 4.5mm to 6.5mm, it is highly preferred that the diameter of the opticator 1 of intraocular lens is arrived in 5.0mm
Between 6.0mm.3 common groups of the coupling part that the opticator 1 of intraocular lens, 1 periphery of opticator are connected with support section 2
Into artificial lenticular main body, the main diameter 5 of intraocular lens preferably arrives between 5.5mm to 8.0mm in 6.0mm
Between 7.5mm, more preferably between 6.2mm to 7.0mm.Support section 2（Such as support button loop）It is implanted into for intraocular lens
Position afterwards is fixed.Preferably, the present invention is using template button loop or flat button loop.In some embodiments, the support of intraocular lens
Part 2 has location hole or helps the hole 6 of aqueous humor circulation.
In some embodiments, the center thickness of intraocular lens is between 0.05mm to 0.50mm, is preferably existed
Between 0.08mm to 0.20mm, more preferably between 0.10mm to 0.15mm.As shown in Figure 1 b, intraocular lens's vault is high by 7
Refer to perpendicular to optical axis, natural lens nearside intraocular lens's vertex plane and perpendicular to optical axis, do not pressurize when it is closest
The distance between intraocular lens's plane of cornea.In some embodiments, intraocular lens's vault high 7 is arrived in 1.00mm
Between 1.80mm, preferably between 1.10mm to 1.60mm, more preferably between 1.20mm to 1.50mm.
The intraocular lens of the present invention has negative diopter, it is preferable that intraocular lens have in aqueous humor 0 to-
The diopter of 30.0D, it is highly preferred that intraocular lens has 0 diopter for arriving -25.0D in aqueous humor, it is highly preferred that manually
Crystalline lens has the diopter that -3.0D arrives -25.0D in aqueous humor.The forward and backward surface of intraocular lens's opticator for it is flat-recessed,
Concave-concave or male-female structure, it is preferable that intraocular implants' optic is double-concave structure.The optical section of intraocular lens at least one
A surface is aspherical, can be that front surface is aspherical, can be that rear surface is aspherical or front surface and rear table
Face is aspherical.
The intraocular lens of the present invention is capable of providing desired spherical aberration and/or diopter after abundant water swelling.It is preferred that
Ground, the spherical aberration that intraocular lens of the invention provides after abundant water swelling is zero and/or diopter is 0 to -30.0D, excellent
Selection of land arrives -25.0D for -3.0D.
The intraocular lens of the present invention is by having the acrylate materials of certain water content to be made, material water swelling
Afterwards, flexible folding.In some embodiments, the coefficient of expansion of the flexible folding acrylate material is 1.01 to 1.615
Between；Preferably, the coefficient of expansion of the flexible folding acrylate material is between 1.01 to 1.29；It is highly preferred that this is soft
The coefficient of expansion of the foldable acrylate material of property is between 1.04 to 1.20.The refraction of the flexible folding acrylate material
Rate is between 1.375 to 1.530；Preferably, the refractive index of the flexible folding acrylate material 1.406 to 1.530 it
Between；It is highly preferred that the refractive index of the flexible folding acrylate material is between 1.438 to 1.502.
Manufacturing method provided by the present invention eliminates material hydrates expansion and weakens the influence to aspheric design, eliminates picture
It is poor disorderly, make intraocular lens obtain expected from aberration modification effect, improve the optical quality of Intraocular lens eye.
Fig. 5 is for manufacturing method using the present invention and using common manufacturing methods（Without considering the coefficient of expansion）Have crystal eye
Intraocular lens is implanted to the MTF after same standard human-eye model.As it can be seen that the method that the present invention uses can obtain Intraocular lens eye
Obtain better optical quality.
Fig. 6 is for manufacturing method using the present invention and using common manufacturing methods（Without considering the coefficient of expansion）Have crystal eye
Intraocular lens is implanted to the Seidel aberration profile figures after same standard human-eye model.As it can be seen that method energy using the present invention
Enough make all kinds of aberration smallers of human eye, eliminate material hydrates expansion and weaken the influence to aspheric design, and it is disorderly to eliminate aberration
Disorderly.
Embodiment described above is exemplary only and not restrictive, is not departing from invention disclosed herein
In the case of design, it can modify, combine or replace to the embodiment above.
Claims (18)
1. a kind of manufacturing method of intraocular lens, before the intraocular lens is implanted to the human eye with natural lens
In room or back room, to change the refractive status of human eye, the intraocular lens includes opticator, support section and in light
The coupling part being connected with support section that the department of the Chinese Academy of Sciences exceptionally encloses, the opticator include front surface and rear surface, the preceding table
At least one including aspherical in face and the rear surface, the intraocular lens by being capable of the material of water swelling after hydration
Material is made, and the manufacturing method includes the following steps：
（a）Determine the target component of desired realization after the abundant water swelling of the intraocular lens；
（b）Intermediate parameters before intraocular lens's water swelling are determined according to the target component, and according in described
Between parameter determine the structural parameters of the intraocular lens；
（c）The material manufacture intraocular lens before water swelling is utilized according to structural parameters；
（d）Make the abundant water swelling of intraocular lens；
（e）Intraocular lens after abundant water swelling is detected, obtains the manually lenticular actual parameter；
（f）By actual parameter compared with the target component；
（g）If the difference between actual parameter and the target component adjusts ginseng among described beyond predetermined threshold range
It counts to obtain adjusted intermediate parameters and determine the structure of the intraocular lens according to the adjusted intermediate parameters
Parameter, if difference between actual parameter and the target component without departing from predetermined threshold range, will be manufactured artificial
Crystalline lens is as final intraocular lens；And
（h）If the difference between actual parameter and the target component exceeds predetermined threshold range, repeatedly step（c）-
（g）.
2. manufacturing method as described in claim 1, wherein, the table of the aspherical curve on two-dimensional coordinate system plane rZ
It is up to formula：
Wherein, R is the radius of curvature of the aspherical basic spherical surface, and r is any point on the curve away from axis of abscissas Z's
Vertical range, A2iFor aspherical high order term coefficient, m, n are the integer and n not less than 1>M, Q are asphericity coefficient,
Wherein, each point in the aspherical face shape carries out rotational symmetry variation by the curve negotiating around axis of abscissas Z
And obtain, and
Wherein, the radius of curvature of structural parameters including the front surface, radius of curvature of the rear surface, described aspherical
Coefficient and the aspherical high order term coefficient.
3. manufacturing method as claimed in claim 2, wherein, the step（b）According to determining the intermediate parameters
The structural parameters of intraocular lens include determining the radius of curvature of the front surface, the rear surface according to the intermediate parameters
Radius of curvature, the asphericity coefficient and the aspherical high order term coefficient；And wherein, the step（c）According to knot
Structure parameter utilizes the coefficient of expansion further included before the material manufacture intraocular lens before water swelling according to the material
Structural parameters are adjusted, wherein, adjusting structural parameters according to the coefficient of expansion of the material includes：
By the radius of curvature divided by k of identified front surface,
By the radius of curvature of identified rear surface divided by k and
By identified aspherical high order term coefficient A2iIt is multiplied by respectively,
Wherein, k is the coefficient of expansion of the material.
4. manufacturing method as claimed any one in claims 1 to 3, wherein, the target component include target refraction degree and/
Or target spherical aberration, the intermediate parameters include intermediate diopter and/or intermediate spherical aberration, wherein, the target refraction degree is artificial
The diopter of desired realization after the abundant water swelling of crystalline lens, after the target spherical aberration is the abundant water swelling of intraocular lens
The spherical aberration of desired realization, the intermediate diopter are the diopters before intraocular lens's water swelling, and the intermediate spherical aberration is
Spherical aberration before intraocular lens's water swelling.
5. manufacturing method as claimed in claim 4, wherein, the target spherical aberration is zero.
6. manufacturing method as claimed in claim 4, wherein, the target refraction degree is 0 to -30.0D, it is therefore preferable to -3.0D
To -25.0D.
7. manufacturing method as described in any of claims 4, wherein, step（b）In determined according to the target component
Intermediate parameters before intraocular lens's water swelling include：The intermediate diopter is determined as to be equal to target refraction degree
And/or the intermediate spherical aberration is determined as to be equal to target spherical aberration.
8. manufacturing method as described in any of claims 4, wherein, step（b）In determined according to the target component
Intermediate parameters before intraocular lens's water swelling include：The intermediate diopter is determined as than the target refraction degree
More negative value and/or the value for being determined as correcting than the target spherical aberration by the intermediate spherical aberration.
9. manufacturing method as described in any of claims 4, wherein, step（g）In the adjustment intermediate parameters include：
The intermediate diopter is adjusted to value more more negative than the target refraction degree and/or the intermediate spherical aberration is adjusted to than described
The value of target spherical aberration corrigendum.
10. manufacturing method as described in claim 1, wherein, the material is acrylate materials, and the coefficient of expansion exists
Between 1.01 to 1.615, preferably between 1.01 to 1.29, more preferably between 1.04 to 1.20.
11. manufacturing method as described in claim 1, wherein, the material is acrylate materials, and refractive index is 1.38
To between 1.55, preferably between 1.44 to 1.53, more preferably between 1.48 to 1.51.
12. manufacturing method as described in claim 1, wherein, the material is acrylate materials, and water content is 3.5%
To between 74.5%, preferably between 6% to 38%, more preferably between 8% to 20%.
13. manufacturing method as described in claim 1, wherein, the overall diameter of the intraocular lens is in 11.0 mm to 14.5
Between mm, preferably between 11.5 mm to 14.2 mm, more preferably between 11.8 mm to 13.9 mm.
14. manufacturing method as described in claim 1, wherein, the diameter of the opticator is more than or equal to 4.2 mm, preferably
Ground is between 4.5 mm to 6.5 mm, more preferably between 5.0 mm to 6.0 mm.
15. manufacturing method as described in claim 1, wherein, the opticator and the coupling part collectively constitute manually
Lenticular main body, the diameter of the main body is between 5.5 mm to 8.0 mm, preferably between 6.0 mm to 7.5 mm, more
Preferably between 6.2 mm to 7.0 mm.
16. manufacturing method as described in claim 1, wherein, the center thickness of the intraocular lens is arrived in 0.05 mm
Between 0.50mm, preferably between 0.08 mm to 0.20mm, more preferably between 0.10 mm to 0.15mm.
17. manufacturing method as described in claim 1, wherein, the vault height of the intraocular lens is arrived in 1.00 mm
Between 1.80mm, preferably between 1.10 mm to 1.60mm, more preferably between 1.20 mm to 1.50mm.
18. a kind of intraocular lens of manufacturing method manufacture using as any one of claim 1-17.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108836571A (en) * | 2018-07-13 | 2018-11-20 | 爱博诺德（北京）医疗科技有限公司 | Artificial lenses |
| CN112494175A (en) * | 2020-11-25 | 2021-03-16 | 杭州爱晶伦科技有限公司 | Posterior chamber type aspheric intraocular lens with lens |
| CN113367840A (en) * | 2021-08-12 | 2021-09-10 | 微创视神医疗科技(上海)有限公司 | Intraocular lens and method of making same |
| US11766324B2 (en) | 2018-07-13 | 2023-09-26 | Eyebright Medical Technology (Beijing) Co., Ltd. | Intraocular lens and manufacturing method therefor |
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| CN104783925A (en) * | 2015-01-09 | 2015-07-22 | 爱博诺德（北京）医疗科技有限公司 | Multi-focal artificial lens |
| CN106901873A (en) * | 2017-03-09 | 2017-06-30 | 首都医科大学附属北京同仁医院 | The preparation method of intraocular lens |
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| CN104783925A (en) * | 2015-01-09 | 2015-07-22 | 爱博诺德（北京）医疗科技有限公司 | Multi-focal artificial lens |
| CN106901873A (en) * | 2017-03-09 | 2017-06-30 | 首都医科大学附属北京同仁医院 | The preparation method of intraocular lens |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108836571A (en) * | 2018-07-13 | 2018-11-20 | 爱博诺德（北京）医疗科技有限公司 | Artificial lenses |
| US11766324B2 (en) | 2018-07-13 | 2023-09-26 | Eyebright Medical Technology (Beijing) Co., Ltd. | Intraocular lens and manufacturing method therefor |
| CN108836571B (en) * | 2018-07-13 | 2024-05-28 | 爱博诺德(北京)医疗科技股份有限公司 | Artificial lens |
| CN112494175A (en) * | 2020-11-25 | 2021-03-16 | 杭州爱晶伦科技有限公司 | Posterior chamber type aspheric intraocular lens with lens |
| CN113367840A (en) * | 2021-08-12 | 2021-09-10 | 微创视神医疗科技(上海)有限公司 | Intraocular lens and method of making same |
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| Publication number | Publication date |
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| CN108078654B (en) | 2020-02-07 |
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