RU2706303C1 - Method for determining indications for an anti-angiogenic therapy of macular edema in post-thrombotic retinopathy - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, specifically to ophthalmology. Method for determining indications for conducting an anti-angiogenic therapy of macular edema in post-thrombotic retinopathy involves performing coherent optical tomography of the affected patient's macula, wherein thickness of central area of retina (TR), mm, and total volume of macula (VM), mm³, affected eye. Coefficient of readings (K) is calculated by formula: K=exp(-13.9+12.09×TR+0.33×VM)/[1+exp(-13.9+12.09×TR+0.33×VM)], where exp – exponential equal to 2.72. If condition 0.00039<K≤0.75 is satisfied, anti-angiogenic therapy of macular edema in post-thrombotic retinopathy is considered to be indicated.

EFFECT: use of the invention enables higher accuracy of determining readings for the anti-angiogenic therapy of macular edema in post-thrombotic retinopathy.

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Description

The present invention relates to medicine, namely to ophthalmology, and can be used to determine the indications for antiangiogenic therapy of macular edema in post-thrombotic retinopathy.

Post-thrombotic retinopathy is a symptom complex of pathological changes induced by prolonged ischemia, consisting of vascular collaterals, shunts, dilated intraretinal capillaries, micro and macro aneurysms, neovascularization, macular edema that develops in the retina 1-3 months after acute circulatory disturbance in the venous duct therapy in ophthalmology / under the editorship of Boyko E.V., Sosnovsky S.V., Berezin R.D. et al. - St. Petersburg: VMMA named after S.M.

The prevalence of retinal vein thrombosis is about 2.14 cases per 1000 people. The age of patients ranges from 14 to 92 years. The largest group of patients with retinal vein thrombosis are patients aged 40 years and older, with an average of 51.4 - 65.2 years. In 67.2% of cases, thrombosis of the branches of the central retinal vein occurs, of which the upper temporal branch of the central retinal vein is most often affected (Ophthalmology: national leadership / under the editorship of Avetisov S.E., Egorova E.A., Moshetova L.K. . et al. - M.: GEOTAR - Media, 2018 .-- P. 599).

The progressive nature of the course of macular edema in post-thrombotic retinopathy can lead to blindness, disability, disability, social maladaptation and disability (Libman E.S., Shakhova E.V. Condition and dynamics of blindness and disability due to pathology of the organ of vision in Russia // 7 Congress of Ophthalmologists of Russia: abstracts - Moscow, 2000 .-- S. 209-214).

Currently, antiangiogenic therapy of macular edema in post-thrombotic retinopathy is the standard of treatment and is carried out by introducing angiogenesis inhibitors into the vitreous body. However, not always prescribed and conducted anti-angiogenic therapy is effective (Retinal vein occlusion: guidelines / under the editorship of Yu.S. Astakhov, S.N. Tultseva - St. Petersburg: ECO VECTOR, 2017. - P. 48-51), therefore the development of highly effective methods for determining indications and developing appointment criteria for antiangiogenic therapy of macular edema in post-thrombotic retinopathy with a predictable positive treatment outcome is an urgent task of modern ophthalmology.

A search by patent and scientific and medical literature found the one described in the monograph (Antiangiogenic therapy in ophthalmology / edited by Boyko E.V., Sosnovsky SV., Berezina R.D. et al. - St. Petersburg: VMedA named after SM. Kirov, 2013. - P. 255) a method for determining indications for antiangiogenic therapy of macular edema in post-thrombotic retinopathy, which we adopted as a prototype.

The method involves performing optical coherence tomography of the macula of the affected eye, the results of which determine the thickness of the central zone of the retina. With a thickness of the central zone of the retina up to 400 μm, a patient with macular edema with post-thrombotic retinopathy is considered to be indicated for antiangiogenic therapy.

The disadvantages of the prototype is the lack of reliability of the method (Occlusion of the veins of the retina: guidelines / under the editorship of Astakhov Yu.S., Tultseva S.N. - St. Petersburg: ECO VECTOR, 2017.- S. 48-51) and its limited functionality: antiangiogenic therapy is indicated only for low edema with a thickness of the central zone of the retina up to 400 microns.

The objective of the invention is to develop a reliable method for determining the indications for antiangiogenic therapy of macular edema in post-thrombotic retinopathy.

The technical result manifested in the implementation of the proposed method is to increase the reliability of determining the indications for antiangiogenic therapy of macular edema in post-thrombotic retinopathy.

The technical result is achieved by performing optical coherence tomography of the macula of the affected eye of the patient, the results of which determine the thickness of the central zone of the retina (TS), mm and the total volume of the macula (OM), mm3. Then calculate the coefficient of readings (K) according to the formula:

K = exp (-13.9 + 12.09xTC + 0.33xOM) / [1 + exp (-13.9 + 12.09xTC + 0.33xOM)], where exp is the exponent equal to 2.72. If the condition 0.00039 <K <0.75 is fulfilled, antiangiogenic therapy of macular edema in post-thrombotic retinopathy is considered indicated.

To develop a method for determining indications for anti-angiogenic therapy of macular edema in post-thrombotic retinopathy, we performed a retrospective analysis of case histories of 35 patients (35 eyes): 18 men and 17 women aged 43 to 72 years, with macular edema in post-thrombotic retinopathy, which the ophthalmology department of the State budget institution of the Rostov region "Rostov Regional Clinical Hospital" (GBU RO "ROKB") received anti-angiogenic therapy, and who received polio itelny result - remission as a result of anti-angiogenic therapy.

A control group of 30 people (30 eyes) was also formed: 15 men and 15 women of the same age group, but without pathology of the organ of vision. All of them underwent measurement of visual acuity, measurement of intraocular pressure, measurement of visual fields, fundus examination, fluorescence fundus angiography, and optical coherence tomography was performed.

Statistical processing of data from a retrospective analysis of the above case histories and the results of studies of subjects examined in the control group, performed using the Statistica 10.0 computer program (StatSoftInc, USA), allowed us to determine statistically significant (p <0.05) indicators: thickness of the central zone of the retina (TS) ), the total volume of the macula (OM) and the coefficient of indications (K), if the value of which meets the above condition, antiangiogenic therapy of macular edema in post-thrombotic retinopathy with itayut shown.

The reliability of these criteria was confirmed by the results of anti-angiogenic therapy in 68 patients with macular edema in post-thrombotic retinopathy conducted in GBU RO ROKB.

Detailed description of the method.

A patient diagnosed with macular edema with post-thrombotic retinopathy is performed optical coherence tomography of the macula of the affected eye, for example, on a Cirrus HD-OST model 500 (Carl Zeiss Meditec, Inc., USA), and the thickness of the central zone of the retina (TS) is determined, mm and total macula volume (OM), mm3. Calculate the coefficient of evidence (K) according to the formula:

K = exp (-13.9 + 12.09xTC + 0.33xOM) / [1 + exp (-13.9 + 12.09xTC + 0.33xOM)],

where exp is the exponent equal to 2.72. If the condition 0.00039 <K <0.75 is fulfilled, antiangiogenic therapy of macular edema in post-thrombotic retinopathy is considered indicated.

The feasibility of the proposed method is illustrated by examples from clinical practice.

Example 1: patient N., 57 years old, was hospitalized in the ophthalmology department of GBU RO "ROKB" with a diagnosis of macular edema of the left eye with post-thrombotic retinopathy.

On admission: complaints of low vision in the left eye and a dark “halo” in front of the eye.

From the anamnesis of the disease. After suffering a hypertensive crisis 2 months ago, the patient's vision in the left eye sharply decreased. I contacted an ophthalmologist at the place of residence immediately. Diagnosed with thrombosis of the superior temporal branch of the central retinal vein with macular edema of the left eye. An ocular fundus fluorescence angiography was performed, according to which a non-ischemic type of thrombosis of the superior temporal lobe of the central retina of the left eye was determined.

An ophthalmological examination upon admission established: visual acuity of the right eye - 1.0, visual acuity of the left eye - 0.4. Computer perimetry: on the right eye - a variant of the norm of the visual fields; on the left eye is the relative paracentral scotoma in the lower nasal sector of the visual field. Tonometry data of both eyes noted intraocular pressure within normal values. With ophthalmoscopy: on the right - the optic disc is pale pink, the borders are clear, excavation is 0.4, the signs of angiopathy are hypertonic type; on the left - the optic disc is pale on the temporal side, the boundaries are clear, excavation is 0.5; diffuse retinal edema, occupying the upper quadrants of the macular region, along the upper arteriovenous vascular bundle, collaterals and single shunts are determined. Visible absorbable hemorrhages in the form of spots in the upper temporal retinal quadrant. Arteries are narrowed, veins are moderately dilated and convoluted.

To determine the indications for anti-angiogenic therapy, patient N. was examined according to the claimed method.

Patient N. was subjected to optical coherence tomography of the left eye macula on a Cirrus HD-OST model 500 instrument (Carl Zeiss Meditec, Inc., USA), and the thickness of the central area of the retina (TC), mm and the total volume of the macula (OM) were determined, mm3.

It was obtained: TC = 0.572 mm; OM = 10.22 mm3.

The coefficient of indications (K) was calculated by the formula: K = exp (-13.9 + 12.09xTC + 0.33xOM) / [1 + exp (-13.9 + 12.09xTC + 0.33xOM)],

where exp is the exponent equal to 2.72.

It was obtained: K = 0.026.

Since the condition 0.00039 <K = 0.026 <0.75 was fulfilled, patient N. was shown antiangiogenic therapy for macular edema of the left eye with post-thrombotic retinopathy.

In the ophthalmology department of GBU RO ROKB, patient N. was given an intravitreal injection of the drug Ranibizumab (0.05 ml) in the left eye and the follow-up regimen was recommended: the first 3 months after injection - 1 time per month, subsequently, while maintaining stable remission - 1 time in 3 months.

During the follow-up observation during the year, patient N. was diagnosed with stable remission of an eye disease, which confirmed the reliability of the proposed method.

 Example 2: Patient M, 63 years old, was hospitalized in the ophthalmology department of GBU RO ROKB with a diagnosis of macular edema of the right eye with post-thrombotic retinopathy.

On admission: complaints of reduced vision in the right eye and the appearance of a dark spot in front of the right eye.

From the anamnesis of life: over the past 5 years, has been with a cardiologist at the place of residence registered for hypertension.

From the anamnesis of the disease: two months ago, patient M. had a painless sharp visual impairment in his right eye after exercise. An ocular fundus fluorescence angiography was performed, which revealed thrombosis of the central retinal vein with macular edema of the non-ischemic type of the right eye.

On admission: ophthalmic status - visual acuity of the right eye - 0.2, visual acuity of the left eye - 1.0. Computer perimetry: on the right eye - relative central scotoma; on the left eye is a variant of the norm. Tonometry data of both eyes noted intraocular pressure within normal values. With ophthalmoscopy: on the right - the optic disc is pale on the temporal side, the boundaries are clear, excavation is 0.4; in the macular region, diffuse cystic edema, along the upper and lower arteriovenous vascular bundle, collaterals and single shunts are determined. Resorbable hemorrhages are visible in the form of spots along the arteriovenous temporal vascular bundles. Arteries are narrowed, veins are moderately dilated and convoluted. On the left - the optic nerve disc is pale pink, the borders are clear, the excavation is 0.4, the signs of angioretinopathy are hypertonic.

To determine the indications for anti-angiogenic therapy, patient M. was examined according to the claimed method.

Patient M. performed optical coherence tomography of the macula of the right eye on a Cirrus HD-OST model 500 instrument (Carl Zeiss Meditec, Inc., USA) and determined the thickness of the central zone of the retina (TS), mm and the total volume of the macula (OM), mm3 .

It was obtained: TC = 0.705 mm; OM = 11.98 mm.

The coefficient of indications (K) was calculated by the formula: K = exp (-13.9 + 12.09xTC + 0.33xOM) / [1 + exp (-13.9 + 12.09xTC + 0.33xOM)],

where exp is the exponent equal to 2.72.

It was obtained: K = 0.19.

Since the condition 0.00039 <K = 0.19 <0.75, patient M. was met, antiangiogenic therapy of macular edema of the right eye with post-thrombotic retinopathy was shown.

In the ophthalmology department of GBU RO ROKB, patient M. was given an intravitreal injection of the drug Ranibizumab (0.05 ml) in the right eye and a follow-up regimen was recommended: the first 3 months after injection - 1 time per month, followed by maintaining stable remission - 1 time in 3 months.

During the follow-up observation during the year, patient M. was diagnosed with stable remission of an eye disease, which confirmed the reliability of the proposed method.

Using the proposed method, we examined 80 patients aged 55 to 74 years old who were admitted to GBU RO ROKB with macular edema in post-thrombotic retinopathy.

According to the results of examinations in 68 patients, the value of the coefficient of indications (K) satisfied the condition 0.00039 <K <0.75. For these 68 patients, antiangiogenic therapy of macular edema with post-thrombotic retinopathy was shown and performed. During dynamic observation, all these 68 patients showed stable remission, which confirmed the reliability of the proposed method. Thus, the proposed method is reliable, effective and can be used to determine the indications for antiangiogenic therapy of macular edema in post-thrombotic retinopathy.

Claims (3)

A method for determining indications for anti-angiogenic therapy of macular edema in post-thrombotic retinopathy, including optical coherence tomography of the macula of the affected eye of the patient with determining the thickness of the central zone of the retina (TS), mm, characterized in that it further determines the total volume of the macula (OM), mm, of the affected eyes, calculate the coefficient of evidence (K) according to the formula: K = exp (-13.9 + 12.09xTC + 0.33xOM) / [1 + exp (-13.9 + 12.09xTC + 0.33xOM)], where exp is the exponent equal to 2.72; when the condition 0.00039 <K≤0.75 is fulfilled, antiangiogenic therapy of macular edema in post-thrombotic retinopathy is considered indicated.