Combined Laser-surgical Technology of RRD Treatment

Study Overview
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Brief Summary
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Purpose: to assess the efficacy and safety of combined laser-surgical technology of RRD treatment

Detailed Description
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The study takes place in the S.N. Fyodorov Eye Microsurgery Federal State Institution located in Moscow, Russian Federation. The study will include 50 patients with rhegmatogenous retinal detachment due to a horseshoe-tear. In addition to the standard ophthalmological examination, all patients will undergo wide-field optical coherence tomography to determine the extension and localization of the vitreoretinal traction zone. The obtained data will be used to planning the 1st step of laser-surgical treatment. All patients will undergo a combined laser-surgical technology, which includes 3 steps: 1) Nd-YAG laser excision of the vitreoretinal traction zone 2) pneumatic retinopexy (10% C3F8) 3) barrier laser photocoagulation around retinal break after retinal attachment. The patients are going to be followed up for at least 1 year, the main outcome measures are postoperative primary and final anatomic outcome, BCVA and complications.

Official Title
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Combined Laser-surgical Technology of Rhegmatogenous Retinal Detachment Treatment

Conditions
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Rhegmatogenous Retinal Detachment

Intervention / Treatment
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* Procedure: Combined laser-surgical technology of RRD treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rhegmatogenous retinal detachment extending from the 9-o'clock to the 3-o'clock meridians. Superior retinal break from 9 o'clock to 3 o'clock Single retinal break not greater than 1 clock hours in size Physically and mentally co-operated in post-operative head positioning No (or minimal) proliferative vitreoretinopathy None or mild vitreous hemorrhage. Exclusion Criteria: Severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole, traumas); OR Ocular media opacities Previous ocular surgeries Age <18 years Previous retinal detachment (index eye)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined laser-surgical technology<br>Combined laser-surgical technology includes 3 steps: Nd-YAG laser excision of the vitreoretinal traction zone Pneumatic retinopexy (10% C3F8) Barrier laser photocoagulation around retinal break after retinal attachment. | Procedure: Combined laser-surgical technology of RRD treatment<br>* Nd-YAG laser excision of the vitreoretinal traction zone Pneumatic retinopexy (10% C3F8) barrier laser photocoagulation around retinal break after retinal attachment (2-3 days after pneumatic retinopexy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal reattachment rate | complete retinal re-attachment | in 1 month after gas resorption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical success | complete retinal re-attachment | 3, 6, 12 and 24 months post intervention | 
| Visual acuity | ETDRS | 3, 6, 12 and 24 months post intervention | 
| Visual acuity | Snellen | 3, 6, 12 and 24 months post intervention |