Air Versus Gas Tamponade in Primary Retinal Detachment

Study Overview
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Brief Summary
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Management of primary retinal detachment due to upper retinal break is one of controversial situation that may face ophthalmologists in vitreoretinal subspecialty.

Detailed Description
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There is no single surgical plan for management of primary retinal detachment due to upper retinal break, some surgeons prefer scleral buckling over vitrectomy in cases with no traction over the retinal break, others prefer to perform primary pars-plana vitrectomy with either air or gas tamponade. In this study we aim to compare the results of air and non-expansile gas tamponade in cases with upper retinal detachment with grade a or b proliferative vitreoretinopathy.

Official Title
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Randomized Trial Comparing Air Versus Gas Tamponade in Primary Retinal Detachment

Conditions
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Retinal Detachment, Proliferative Vitreoretinopathy

Intervention / Treatment
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* Procedure: Pars plana vitrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary rhegmatogenous retinal detachment with upper break with proliferative vitreoretinopathy from grade a to b. Exclusion Criteria: cases with combined tractional retinal detachment. cases with recurrent retinal detachment. cases that are eligible for scleral buckling that have no traction on retinal break.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Air tamponade group<br>Cases with primary upper retinal detachment that will be treated with air tamponade. | Procedure: Pars plana vitrectomy<br>* 23 gauge pars plana vitrectomy for managing primary retinal detachment.<br>|
| Active Comparator: Non expansile gas tamponade group<br>Cases with primary upper retinal detachment that will be treated with sulfur-hexafluoride 6 (SF-6) gas tamponade. | Procedure: Pars plana vitrectomy<br>* 23 gauge pars plana vitrectomy for managing primary retinal detachment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in visual acuity | Visual acuity changes measured by snellen chart and converted to LogMar units. | Change from baseline visual acuity at 6th month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in metamorphopsia | Changes in metamorphopsia after surgery assessed by M-chart that is specially designed to subjectively assess metamorphopsia, each 1 millimeter deviation from reference line is considered significant deviation. | Change from baseline metamorphopsia at 6th month. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitrectomy, Retinal detachment