Air Versus Gas Tamponade in Primary Retinal Detachment

Not Applicable

Recruiting

• Conditions: Retinal Detachment; Proliferative Vitreoretinopathy
• Interventions: Procedure: Pars plana vitrectomy

• Registration Number: NCT05561569
• Lead Sponsor: Benha University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-26
• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-28
• Last Update Submitted: 2022-09-28
• Study First Posted: 2022-09-30
• Last Update Posted: 2022-09-30
• Primary Completion: 2023-06-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Air tamponade group	Pars plana vitrectomy	Cases with primary upper retinal detachment that will be treated with air tamponade.
Non expansile gas tamponade group	Pars plana vitrectomy	Cases with primary upper retinal detachment that will be treated with sulfur-hexafluoride 6 (SF-6) gas tamponade.

Primary Outcome Measures

Name	Time	Method
Improvement in visual acuity	Change from baseline visual acuity at 6th month.	Visual acuity changes measured by snellen chart and converted to LogMar units.

Secondary Outcome Measures

Name	Time	Method
Changes in metamorphopsia	Change from baseline metamorphopsia at 6th month.	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.

Trial Locations

Locations (1)

Ahmed Abdelshafy; 🇪🇬 Banhā, QA, Egypt