RU2796941C1 - METHOD OF LASER TREATMENT OF DIFFUSE DIABETIC MACULAR EDEMA ON NLI NAVILAS 577s - Google Patents

Abstract

FIELD: medicine; ophthalmology.

SUBSTANCE: patient is preliminarily subjected to optical coherence tomography (OCT) which determines the central retinal thickness (CRT), and if the CRT is 450 μm or less, diagnosis and treatment of diffuse diabetic macular edema (DME) is carried out. The topographic localization of ischemic zones is determined according to the complex analysis of optical coherence tomography-angiography (OCT-A) at the levels of the superficial vascular plexus (SVP) and deep vascular complex (DVC) by switching the Superficial and Deep modes in the OCT software -A. The presence of microaneurysms is determined by OCT angiograms performed in the En Face mode at the DVC level. Next, two identical color photographs of the fundus are taken on the NLI using the software, digital OCT-A images are superimposed and compared with color photographs of the fundus: SVP on the first color photograph of the fundus, then DVC on the second color photograph of the fundus. Then, using the NLI software, the required parameters of laser radiation are set: in the macular zone, excluding the foveal avascular zone (FAZ), the diameter of the laser radiation spot is 50–100 microns, the exposure is 0.05–0.1 s, the power is 50–150 mW, wavelength is 577 nm, outside the laser spot diameter is 100–200 microns, exposure is 0.1–0.2 s, power is 100–350 mW, wavelength is 577 nm, a pattern is selected in the NLI software, the applicators are applied at a distance of 1.5 diameters from each other, in such a way as to completely cover the ischemia zones in the fundus, in accordance with the plan formed on the first color photograph with the overlay of the optical coherence tomogram-angiogram of the SVP, and the area microaneurysms on the second color photograph with an overlay of an optical coherence tomogram-angiogram of DVC. One month after the treatment, OCT-A is performed: when the retina is attached, the patient is transferred to a dispensary observation, and if there are signs of DME, repeated laser coagulation is performed with the above parameters until it is completely attached. If the value of the CRT index is over 450 μm, an intravitreal injection of an angiogenesis inhibitor (anti-VEGF) is performed, which is used as ranibizumab at a dose of 0.5 mg or aflibercept at a dose of 2 mg. One month after the administration of anti-VEGF, OCT is performed: if the CRT value is over 450 µm, the above sequence of actions is repeated until the CRT value reaches 450 µm or less, with a decrease in the CRT in the fovea to 450 µm or less, diagnostics and treatment of DME are performed as above.

EFFECT: method allows to reduce the area of zones or disappearance of ischemic zones, prevent progression of the disease, reduce leakage from microaneurysms or their closure, resorption of edema, reduce the thickness of the retina, maximize corrected visual acuity (MCVA), central retinal photosensitivity and stabilization of visual functions, as well as reduce the amount of the medicinal products administered and angiogenesis inhibitors injections.

1 cl, 3 ex

Description

The invention relates to medicine, namely to ophthalmology, and can be used to determine the tactics of navigational laser treatment of diffuse diabetic macular edema (DME) based on optical coherence tomography-angiography (OCT-A) data.

Diabetic macular edema occupies one of the leading positions among other causes of decline, up to the complete loss of central vision in people of working age, which determines the importance of early preclinical diagnosis and treatment of this pathology.

Currently, the most informative non-invasive method for determining retinal edema, an indicator of the central thickness of the retina, which determines the tactics of treatment, is optical coherence tomography (OCT), as well as OCT with angiography function, which provides data on a comprehensive analysis of pathological changes at the level of the superficial vascular plexus (PSS) and deep vascular complex (GSC), to additionally determine the topographic localization of retinal ischemia zones, the presence of microaneurysms.

The closest analogue of the invention is a method for treating diffuse DME using the Navilas navigation laser system (RF patent for the invention No. 2768483), which consists in the fact that the treatment is carried out in a micropulse subthreshold mode, the power is differentiated depending on the distance from the foveal zone.

This method has a number of disadvantages, namely, laser treatment is carried out in the edema zone without taking into account data from a comprehensive analysis of changes in the superficial vascular plexus (PSS) and deep vascular complex (GSC). Laser treatment is carried out without targeted topographically oriented determination of ischemia zones, microaneurysms, taking into account OCT-A data.

The objective of the invention is to develop the safest, most efficient and topographically oriented, in accordance with OCT-A data, method for laser treatment of DME, performed on a navigational laser unit (NLU) Navilas 577s.

The technical result of the proposed method is to reduce the area of zones or the disappearance of ischemic zones, prevent the progression of the disease, reduce leakage from microaneurysms or close them, resorption of edema, reduce the thickness of the retina, which is accompanied by an increase in the maximum corrected visual acuity (BCVA), central retinal light sensitivity and stabilization of visual functions. , as well as a decrease in the use of drugs and the introduction of angiogenesis inhibitors.

The method is carried out as follows: the patient is subjected to OCT, which is used to measure the central retinal thickness (CRT) in the fovea with diffuse diabetic macular edema, with a CTC of 450 μm or less, DME is diagnosed and treated, for which OCT-A is performed in the En Face mode for determination of the topographic localization of ischemic zones according to the data of a complex analysis of OCT-A of the PSS and HSC by switching the "Superficial" and "Deep" modes in the OCT-A software, determine the presence of microaneurysms by OCT angiograms performed in the En Face mode at the level of the HSC, then perform two identical color photographs of the fundus at the NLU. Next, the zones of microaneurysms are determined by OCT-A in the En Face mode at the HSC level, then two identical color photographs of the fundus are taken at the NLU. Using the software, digital OCT-A images are superimposed and compared with color photographs of the fundus: PSS on the first color photograph of the fundus, then HSC on the second color photograph of the fundus. Then, using the NLU software, the necessary parameters of laser radiation are set: in the macular zone, excluding the foveal avascular zone (FAZ), the diameter of the laser radiation spot is 50-100 microns, the exposure is 0.05-0.1 s, the power is 50-150 mW, wavelength - 577 nm, outside the laser spot diameter - 100-200 microns, exposure - 0.1-0.2 s, power - 100-350 mW, wavelength - 577 nm, selected in the NLU software pattern, the applicators are applied, placing them at a distance of 1.5 diameters from each other, so as to completely cover the ischemia zones in the fundus, in accordance with the plan formed on the first color photograph with the overlay of the optical coherence tomogram-angiogram of the PSS, and the area microaneurysms on the second color photograph with an overlay of an optical coherence tomogram-angiogram of the HSC; and if the CTS is more than 450 microns, then an intravitreal injection of anti-VEGF is performed, which is used as ranibizumab at a dose of 0.5 mg or aflibercept at a dose of 2 mg, one month after the injection, the patient undergoes OCT, which measures the CTS in the fovea if the CTS in the fovea is more than 450 μm, then an additional intravitreal injection of anti-VEGF, the same drug, is carried out in the same quantities. If, one month after the additional anti-VEGF injection, the CTS in the fovea is more than 450 μm, then the indicated sequence of actions, including OCT and anti-VEGF administration, is repeated until the CTS reaches 450 μm or less. With a decrease in the CTS in the fovea to 450 µm or less, DME is diagnosed and treated as described above.

The invention is illustrated by the following clinical examples. Example 1

Patient O., born in 1959, complained of decreased vision and distortion of objects in the left eye during the last 4 months. Objectively: OS - macular reflex is blurred, dispigmentation. According to computer microperimetry foveal photosensitivity - 23.6 dB. BCVA OD 0.9; OS 0.5. Performed OCT, CTS was 436 microns. OCT-A method: macular edema, ischemia zones in the macular and paramacular zone of OS, microaneurysms were determined.

Diffuse DME was treated by the proposed method, while taking into account that the CTS was less than 450 μm, the introduction of anti-VEGF was not carried out. Over the entire area of the DMA, as well as in the zones of ischemia, microaneurysms within its boundaries, determined according to OCT-A data, were targeted application of laser applicators, the applicates were applied at a distance of 1.5 diameters from each other, with the following parameters - in the macular zone, the diameter coagulates 50 μm, power - 50 mW, exposure - 0.05 sec, the number of coagulates - 47, in the paramacular zone, the diameter of coagulates is 100 μm, power - 100 mW, exposure - 0.1 sec, the number of coagulates - 69. One month after the treatment subjectively noted a decrease in distortion, according to microperimetry revealed an increase in the index of foveal photosensitivity - 24.3 dB. BCVA OD 0.9; OS 0.8. Ophthalmoscopically observed a decrease in edema, laser coagulates in the area of application. According to OCT-A performed one month later, there was a complete reattachment of the retina, a decrease in ischemia zones in the macular and paramacular zones. The patient was transferred to dispensary observation. 3 months after treatment, stable indicators of foveal photosensitivity were noted according to microperimetry - 24.6 dB, ophthalmoscopically observed - a decrease in edema, laser coagulates in the application area. BCVA OD 0.9; OS 0.8. According to OCT-A macular edema was not observed. No disease progression was observed during the 6-month follow-up period. The patient was transferred to dispensary observation. Thus, after the navigational laser treatment of DME with CTS values less than 450 μm, the retina was completely attached, and the patient did not need intravitreal administration of anti-VEGF.

Example 2. Patient E., born in 1954, complained of decreased vision and distortion of objects in the OD during the last 4 months. Objectively: OD - macular edema, dispigmentation. According to computer microperimetry foveal photosensitivity - 23.7 dB. BCVA OD 0.3; OS 0.9. OCT-A method: macular edema, ischemia zones in the macular and paramacular zone of OS, microaneurysms were determined. The thickness of the PZT is 496 microns. Diffuse DME was treated by the proposed method. The first step was intravitreal administration of anti-VEGF (ranibizumab at a dose of 0.5 mg). One month after the injection, the patient underwent OCT, the CTS was 425 μm, so the next stage of treatment was the targeted application of laser applications to the DMA area. Targeted navigational laser coagulation was performed over the entire area of the DMA, as well as in ischemia zones, within its boundaries, determined according to OCT-A data, applicates were applied at a distance of 1.5 diameters from each other, with the following parameters: in the macular zone, the diameter coagulates 100 microns, power - 150 mW, exposure - 0.1 sec, the number of coagulates - 35, in the paramacular region, the diameter of coagulates is 200 microns, power - 350 mW, exposure - 0.2 sec, the number of coagulates - 58. One month after the treatment subjectively noted a decrease in distortion, according to microperimetry, an increase in the index of foveal photosensitivity was noted - 24.5 dB. BCVA OD 0.5; OS 0.9. Ophthalmoscopically observed a decrease in edema, laser coagulates in the area of application. According to OCT-A performed one month later, there was a complete reattachment of the retina, a decrease in ischemia zones in the macular and paramacular zones. 3 months after treatment, stable indicators of foveal photosensitivity were noted according to microperimetry - 24.5 dB, ophthalmoscopically observed a decrease in edema, laser coagulates in the application area. According to OCT-A performed one month later, there was a complete reattachment of the retina, a decrease in ischemia zones in the macular and paramacular zones. No disease progression was observed during the 6-month follow-up period. The patient was transferred to dispensary observation. Thus, after the navigational laser treatment, the resorption of macular edema was determined, and the patient did not need intravitreal injections of anti-VEGF.

Example 3. Patient Zh., born in 1967, complained of decreased vision, lack of clarity and distortion of the image in the left eye during the last 2 months. According to computer microperimetry, foveal photosensitivity was 24.2 dB. BCVA OD 0.8; OS 0.3. Objectively: OS - macular edema, dispigmentation. Macular edema, ischemia zones in the macular and paramacular zone of OS, microaneurysms were determined according to OCT-A - OS data. The PZT was 607 µm. DME was treated by the proposed method. The first step was intravitreal administration of anti-VEGF (aflibercept at a dose of 2 mg). One month after the injection, the patient underwent OCT, the CTS was 531 microns, the patient underwent a second intravitreal injection of the same drug at the above dosage. One month after the second injection, the patient underwent OCT, the CTS was 479 μm, the patient underwent the third intravitreal injection with the same drug at the above dosage. One month after the third injection, the patient underwent OCT, the CTS value was 440 μm, so the next stage of treatment was the targeted application of laser applications to the DMA. Navigated laser coagulation was carried out over the entire area of the DMA, as well as in ischemia zones, within its boundaries, determined according to OCT-A data, applicates were applied at a distance of 1.5 diameters from each other, with the following parameters: in the macular zone, the diameter of coagulates was 100 μm, power - 50 mW, exposure - 0.05 sec, the number of coagulates - 54, in the paramacular region, the diameter of the coagulates is 200 μm, power - 100 mW, exposure - 0.1 sec, the number of coagulates - 67. One month after the treatment subjectively, there was a decrease in distortion, according to microperimetry, the foveal photosensitivity was 24.7 dB. BCVA OD 0.8; OS 0.5. Ophthalmoscopically observed a decrease in edema, laser coagulates in the area of application. According to OCT-A performed one month later, there was a resorption of macular edema, a decrease in ischemia zones in the macular and paramacular regions. Three months after treatment, stable indicators of foveal photosensitivity were noted. The patient was transferred to dispensary observation. Thus, after the navigational laser treatment, the retina was completely reattached; the patient did not need intravitreal injections of anti-VEGF.

Claims (1)

A method for laser treatment of diffuse diabetic macular edema (DME) on a Navilas 577s NLU, including laser exposure, characterized in that the patient is previously subjected to optical coherence tomography (OCT), which determines the central retinal thickness (CRT), and if the CTP is 450 μm and less, then diagnostics and treatment of DME are carried out, for which the topographic localization of ischemic zones is determined according to the data of a comprehensive analysis of OCT angiograms at the levels of the superficial vascular plexus (PSS) and deep vascular complex (GSC) by switching the "Superficial" and "Deep" modes to using the OCT-A software, the presence of microaneurysms is determined by OCT angiograms performed in the En Face mode at the HSC level, then two identical color photographs of the fundus on the NLU are taken, using the software, digital OCT-A images are superimposed and compared with color photographs of the eye bottom: PSS on the first color photograph of the fundus, then HSC on the second color photograph of the fundus, then using the NLU software, the necessary parameters of laser radiation are set: in the macular zone, excluding the foveal avascular zone (FAZ), the diameter of the laser radiation spot is 50- 100 μm, exposure - 0.05-0.1 s, power - 50-150 mW, wavelength - 577 nm, outside the laser spot diameter - 100-200 μm, exposure - 0.1-0.2 s , power - 100-350 mW, wavelength - 577 nm, select a pattern in the NLU software, apply applicators, placing them at a distance of 1.5 diameters from each other, so as to completely cover the ischemic zones in the fundus, in accordance with the plan formed on the first color photograph with the overlay of the optical coherence tomogram-angiogram of the PSS, and the area of microaneurysms on the second color photograph with the overlay of the optical coherence tomogram-angiogram of the HSC, one month after the treatment, OCT-A is performed: with the retina attached, the patient is transferred to dispensary observation, and in the presence of signs of DME, repeated laser coagulation is performed with the above parameters until complete adherence; if the CTS value is more than 450 μm, an intravitreal injection of an angiogenesis inhibitor (anti-VEGF) is performed, which is used as ranibizumab at a dose of 0.5 mg or aflibercept at a dose of 2 mg, OCT is performed one month after the administration of anti-VEGF: if the CTS indicator more than 450 microns, then repeat the above sequence of actions until the CTS indicator reaches 450 microns or less, with a decrease in the CTS in the fovea to 450 microns or less, DME is diagnosed and treated, as indicated above.