CN112754422A - Visual chart suitable for clinical test and use method thereof - Google Patents

Abstract

The invention discloses an optometer suitable for clinical test and a using method thereof, wherein the optometer size, geometric increment rate, line number, optometer interval and line spacing of the optometer adopt international standards, and the innovation point is that each line of optometer of the optometer (table R) consists of 1 notched C optometer and 4 rolling E optometers. Both optotypes had 4 orientations up/down/left/right. The "ETDRS visual acuity chart" and the standardized operating specifications for ETDRS optometry "are the gold standards for international pharmaceutical clinical trials. The invention provides two visual target combinations in a newly designed optometry table on the basis of the E visual targets which are usually rolled by Chinese people, namely 1C visual target in each row of rolling E visual targets, so that the invention is more in line with the identification and expression habits of Chinese people when in use, and simultaneously can be used for qualitatively and quantitatively measuring and verifying the axial direction of astigmatism and the degree of astigmatism of a subject, and can improve the vision detection efficiency and accuracy.

Description

Visual chart suitable for clinical test and use method thereof

Technical Field

The invention relates to an eye chart suitable for clinical tests and a using method thereof.

Background

The classic ETDRS chart was born in 1982 and consisted of three separate letter visual charts, including the optometry chart (table R), the right eye chart (table 1) and the left eye chart (table 2). The National Eye Institute (NEI) at that time required a standardized set of eye charts for a large sample of the "diabetic retinopathy early treatment study" (ETDRS for english acronym). Dr. Rick Ferris integrates 5-letter matrix in each row of Bailey-Loivre logarithmic visual chart and 10 Latin letters in Sloan format into a new visual chart, and the checking distance is 4 meters. The eye chart is approved by the American national eye research institute and the American FDA for the early treatment research of the diabetic retinopathy, so the eye chart is named as an ETDRS eye chart, the letter size (size), the line number, the increment rate, the letter spacing and the line spacing of the ETDRS eye chart are strictly regulated, the used sighting target is the geometric increment rate which is constantly equal to 1.2589 times, and the eye chart is more suitable for clinical tests than the commonly used Snellen eye chart.

In the course of clinical trials using the ETDRS chart, they must be performed according to Standard Operation Protocol (SOP). For example, during the verification of the qualitative and quantitative measurements of the axial and the power of astigmatism for part 2 of the prescription, each round requires a letter for circular or annular fixation, such as O, C for the latin letter in the classic table. In other words, each row of the EDTDRS alphabet eye chart provides at least one letter, either circular or circular, for use in verifying astigmatism.

The classic ETDRS eye chart, consisting of 10 latin letter optotypes in Sloan format, includes table 1, table 2, and table R. The later full rolling E version of ETDRS vision suite and rolling C version of ETDRS vision suite can be used in non-Latin countries. The most common visual chart in China is a standard logarithmic visual chart, and the common visual target is rolling E. The tumbling E visual standard is familiar, recognizable and expressive to our nation. At present, the clinical test of the medicine in China is basically the classic ETDRS visual chart. In the implementation process, for some middle-aged and elderly subjects, even if the letter targets can be clearly identified (seen) in the vision test process, the identified letter targets cannot be accurately described (read), so that the misunderstanding condition can occur, the efficiency of the vision test is seriously affected, and the detection effect can be greatly deviated.

At present, an ETDRS table which fully adopts rolling E as a visual standard exists in the market, has better identification and expression effects for Chinese people, particularly middle-aged and elderly people, but cannot completely meet the standard optometry specification to carry out qualitative and quantitative measurement and verification on the axial degree and the astigmatic degree because of lacking of a circular visual standard.

Disclosure of Invention

Aiming at the defects of the prior art, the invention provides the visual chart suitable for clinical tests and the using method thereof, which are more in line with the identification and expression habits of Chinese, and can be used for qualitative and quantitative measurement and verification of the axial direction of astigmatism and the degree of astigmatism of a tested person, thereby improving the visual detection efficiency and accuracy.

In order to achieve the above object, the present invention provides an eye chart suitable for clinical trials, which comprises a display plane and a plurality of visual targets supported on the display plane, wherein the plurality of visual targets are arranged in 14 rows in a longitudinal direction, each row comprises 5 visual targets arranged in a transverse direction, the size of each visual target in the row is reduced in a geometric series from row to row, the space between 5 visual targets in each row is equal, the space is equal to the width of a single visual target in the row, the row space between two adjacent rows of visual targets in the longitudinal direction is equal to the height of the visual target positioned in the next row of the two visual targets, at least one visual target in each row adopts a C visual target with a notch, the other visual targets in each row adopt rolling E visual targets, and each visual target has an orientation at least corresponding to the upper part/lower part/left part/right part of the display plane.

The invention also provides a using method based on the visual chart, which is applied to an astigmatism axial verification process and an astigmatism power verification process, wherein the astigmatism axial verification process comprises the following steps:

step A1, astigmatism axial verification, namely selecting JCC (joint optic prescription) by using the right cylindrical power adaptive to the eyes of a subject, and enabling the subject to watch the C sighting mark which is 1-2 rows above the lowest row and can be seen on the visual chart;

step A2, the examiner uses JCC to make the JCC handle coincide with the axial direction of the initial cylindrical lens in front of the eye of the subject, namely the position 1, then the JCC is turned over by 180 degrees, namely the position 2, when the subject compares the two positions, the definition of the C sighting mark watched by the subject is the same or one of the two positions is clearer, when the subject feeds back that one of the two positions is clearer, the step A3 is carried out, and when the subject feeds back the same, the step A4 is carried out;

step A3, rotating the positive cylindrical lens of the eye of the subject by 10 degrees to the positive axial direction of JCC with a clear position surface, and then repeating the step A2;

step A4, if the subject uses JCC for the first time, arbitrarily rotating the positive cylindrical lens shaft by 15 degrees and repeating the step A2, confirming the same clear again, if the subject does not use JCC for the first time, entering the step A5;

step A5, reaching the end point of the axial verification of the cylindrical lens;

the astigmatism degree verification process comprises the following steps:

step B1, using positive column lens corresponding to the astigmatism degree of the subject, and letting the subject watch the C sighting mark in the lowest row which can be read on the visual chart;

step B2, the examining doctor continues to use JCC, this time, the positive axis of JCC is made to coincide with the axial direction of the initial cylindrical lens in front of the eye of the subject and is set as position 3, then the JCC is turned over by 180 degrees, the negative axis is made to coincide with the axial direction of the initial cylindrical lens in front of the eye of the subject and is set as position 4, when the subject compares the front position and the rear position, the definition of the C sighting mark watched by the subject is determined, when the feedback of the subject is that one of the positions is clearer, the step B3 is carried out, and when the feedback of the subject is the same, the step B4;

step B3, repeat step B2 after increasing 0.25DC or decreasing 0.25 DC;

and step B4, reaching the end point of the cylindrical degree verification.

The invention has the beneficial effects that: the problems that the classic ETDRS visual chart can not be read conveniently by Chinese people and the pure rolling E visual chart can not finish accurate astigmatism test are solved. The visual chart of the invention is more in line with the reading habit of Chinese people, is especially suitable for middle-aged and elderly people, can make the vision detection process more simple and convenient, improves the vision detection efficiency and the accuracy of the detection result, and is especially suitable for the clinical test and the clinical research of medicaments in China.

Drawings

FIG. 1 is a schematic representation of an embodiment of an eye chart suitable for use in clinical trials of the present invention;

FIG. 2 is a block flow diagram of an axial verification process for astigmatism in a method of use of the invention;

fig. 3 is a block flow diagram of the astigmatism power verification process in the method of use of the invention.

Detailed Description

An embodiment of an eye chart (i.e., table R) suitable for use in clinical trials of the present invention is shown in fig. 1: the visual target comprises a display plane 1 and a plurality of visual targets loaded on the display plane 1, wherein the visual targets are longitudinally arranged in 14 rows, each row comprises 5 visual targets which are transversely arranged, the size of each row of visual targets is reduced in a geometric series from row to row, the distance between 5 visual targets in each row is equal, the distance is equal to the width of a single visual target in the row, the row distance between two adjacent rows of visual targets in the longitudinal direction is equal to the height of the visual target positioned in the next row of the two visual targets, one visual target in each row of 5 visual targets adopts a C visual target with a notch, the notch orientation of the C visual target is the overall orientation of the visual target, other visual targets adopt E visual targets which roll, the two notch orientations of the E visual targets are the overall orientation of the visual targets, and each visual target has an orientation at least corresponding to the upper part/lower part/left part/right part of the display plane, the E and C optotypes in each row have respective orientations. In other embodiments, the directions may not be limited to the four directions "up/down/left/right", and the directions such as left up/left down/right up/right down may be increased according to the accuracy required by the vision inspection.

The adopted C visual target is a Landolt ring, and the C visual target is accepted as a visual target configuration by international ophthalmological meeting in 1909 and meets the standard of the visual target; the E sighting target that rolls adopts also Sloan form, the capital English letter of non-printing body, and the E sighting target that rolls has 4 directions, can express its direction with language and or action, accords with chinese's reading custom, also can make things convenient for middle aged and old people to discern and point out its concrete orientation, can make the vision testing process become more simple and convenient, improves the accuracy nature of vision inspection efficiency and inspection result.

The display plane can be provided by light and thin plastic sheet hardboard, paper that have certain printing opacity effect, during the implementation the display plane can be disposed on the support that the wall perhaps fell to the ground, and the LED lamp plate is disposed at the planar back of show, makes whole display plane can present even and soft light.

The visual chart in this embodiment can be used as the table R in a set of visual charts (table 1, table 2 and table R respectively), and can be matched with a right eye chart (table 1) and a left eye chart (table 2) for simple measurement in specific implementation, and the visual chart is provided with corresponding vision numerical values on two sides of a plurality of rows of visual targets, which represent the vision and equivalent vision values of each row.

An embodiment of the present invention based on the above-mentioned method for using the eye chart is shown in fig. 2-3: the method is applied to an astigmatism axial verification process and an astigmatism power verification process, wherein the astigmatism axial verification process comprises the following steps:

step A1, astigmatism axial verification, namely selecting JCC (joint optic prescription) by using the right cylindrical power adaptive to the eyes of a subject, and enabling the subject to watch the C sighting mark which is 1-2 rows above the lowest row and can be seen on the visual chart;

step A2, the examiner uses JCC to make the JCC handle coincide with the axial direction of the initial cylindrical lens in front of the eye of the subject, namely the position 1, then the JCC is turned over by 180 degrees, namely the position 2, when the subject compares the two positions, the definition of the C sighting mark watched by the subject is the same or one of the two positions is clearer, when the subject feeds back one of the two positions to be clearer, the step A3 is carried out, and when the subject feeds back the same, the step A4 is carried out;

step A3, rotating the axial direction of the positive cylindrical lens in front of the eyes of the subject by 10 degrees to the positive axial direction of the JCC with a clear position surface, and then repeating the step A2;

step A4, if the subject uses JCC for the first time, arbitrarily rotating the positive cylindrical lens shaft by 15 degrees and repeating the step A2, confirming the same clear again, if the subject does not use JCC for the first time, entering the step A5;

step A5, reaching the end point of the axial verification of the cylindrical lens;

the astigmatism degree verification process comprises the following steps:

step B1, using positive column lens corresponding to the astigmatism degree of the eyes of the subject, and enabling the subject to watch the C sighting mark in the lowest row which can be read on the visual chart;

step B2, the examining doctor continues to use JCC, the positive axis of the JCC is made to be axially coincident with the initial cylindrical lens in front of the eye of the subject and is set as position 3, then the JCC is turned over by 180 degrees, the negative axis is made to be axially coincident with the initial cylindrical lens in front of the eye of the subject and is set as position 4, when the subject compares the front position and the rear position, the definition of the C sighting mark watched by the subject is determined, when the feedback of the subject is that one of the positions is clearer, the step B3 is carried out, and when the feedback of the subject is the same, the step B4 is carried out;

step B3, repeat step B2 after increasing 0.25DC (cylinder power) or decreasing 0.25 DC;

and step B4, reaching the end point of the cylindrical degree verification.

The visual chart of the invention simultaneously comprises the visual target E and the visual target C, can be used for measuring the vision and also can be used for optometry, and is mainly used for the main curative effect index of new medicine clinical test or clinical research and the accurate evaluation of vision change; directly for optometry, including verification of sphere and astigmatism, and in particular for verification or verification of the degree of astigmatism and axial direction of the astigmatism.

The invention solves the problems that the traditional visual chart is difficult to read by Chinese people and can not simultaneously solve the problem of accurately correcting astigmatism. The visual chart of the invention is believed to keep the design theory of the bottom layer of the classic ETDRS visual chart and accord with the industry standard, completely accords with the standard Specification (SOP) of the classic ETDRS vision when in use, and is more in accordance with the reading habit of Chinese people.

The above embodiment is only one of the preferred embodiments of the present invention, and general changes and substitutions by those skilled in the art within the technical scope of the present invention are included in the protection scope of the present invention.

Claims (2)

1. An eye chart suitable for use in clinical trials, comprising: including the show plane, bear a plurality of optotypes on the show plane, a plurality of optotypes are vertically arranged into 14 lines, and every line all includes 5 transverse arrangement's optotype, and the size of every line of optotype is row by row downwards to be the geometric progression and reduces, and the interval of every line 5 optotypes equals, and the interval size equals with the width of the single optotype on this line, and the line interval between two vertical adjacent lines of optotypes equals with being located the height of the optotype of next line in two lines of optotypes, and one of them optotype in every line 5 optotypes adopts the C optotype of taking the breach, and other optotypes then all adopt the E optotype that rolls, and every optotype all has the orientation that corresponds show plane top/below/left/right side at least.

2. A method for using the eye chart according to claim 1, wherein the method comprises the following steps: the method is applied to an astigmatism axial verification process and an astigmatism power verification process, wherein the astigmatism axial verification process comprises the following steps:

step A1, astigmatism axial verification, namely selecting JCC (joint optic prescription) by using the right cylindrical power adaptive to the eyes of a subject, and enabling the subject to watch the C sighting mark which is 1-2 rows above the lowest row and can be seen on the visual chart;

step A2, the examiner uses JCC to make the JCC handle coincide with the axial direction of the initial cylindrical lens in front of the eye of the subject, namely the position 1, then the JCC is turned over by 180 degrees, namely the position 2, when the subject compares the two positions, the definition of the C sighting mark watched by the subject is the same or one of the two positions is clearer, when the subject feeds back that one of the two positions is clearer, the step A3 is carried out, and when the subject feeds back the same, the step A4 is carried out;

step A3, rotating the positive cylindrical lens of the eye of the subject by 10 degrees to the positive axial direction of JCC with a clear position surface, and then repeating the step A2;

step A4, if the subject uses JCC for the first time, arbitrarily rotating the positive cylindrical lens shaft by 15 degrees and repeating the step A2, confirming the same clear again, if the subject does not use JCC for the first time, entering the step A5;

step A5, reaching the end point of the axial verification of the cylindrical lens;

the astigmatism degree verification process comprises the following steps:

step B1, using positive column lens corresponding to the astigmatism degree of the subject, and letting the subject watch the C sighting mark in the lowest row which can be read on the visual chart;

step B2, the examining doctor continues to use JCC, this time, the positive axis of JCC is made to coincide with the axial direction of the initial cylindrical lens in front of the eye of the subject and is set as position 3, then the JCC is turned over by 180 degrees, the negative axis is made to coincide with the axial direction of the initial cylindrical lens in front of the eye of the subject and is set as position 4, when the subject compares the front position and the rear position, the definition of the C sighting mark watched by the subject is determined, when the feedback of the subject is that one of the positions is clearer, the step B3 is carried out, and when the feedback of the subject is the same, the step B4;

step B3, repeat step B2 after increasing 0.25DC or decreasing 0.25 DC;

and step B4, reaching the end point of the cylindrical degree verification.

Images