Evaluation of Visual Functions After Pars Plana Vitrectomy With and Without Internal Limiting Membrane Peeling in RRD

Study Overview
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Brief Summary
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Internal limiting membrane peeling is performed during vitrectomy for macular diseases such as macular holes, macular edema due to diabetic retinopathy and retinal vein occlusion. The incidence of epiretinal membrane formation after vitrectomy for rhegmatogenous detachment has been reported to range from 4.4% to 12.8%. In this study, the efficacy and safety of internal limiting membrane peeling will be studied in vitrectomy for rhegmatogenous retinal detachment and if it is essential to peel it in those cases or not.

Detailed Description
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interventional observational study comparing vitrectomy with versus without internal limiting membrane peeling in cases of rhegmatogenous retinal detachment.

Official Title
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Evaluation of Primary Internal Limiting Membrane Peeling in Cases of Rhegmatogenous Retinal Detachment

Conditions
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Retinal Detachment

Intervention / Treatment
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* Other: Pars Plana Vitrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All eyes with recent macula-off rhegmatogenous retinal detachment (RRD). Exclusion Criteria: Complicated cases with advanced proliferative vitreoretinopathy (PVR). Patients with retinal vascular disorders and other macular disorders. Combined tractional and rhegmatogenous detachment. Previous retinal reattachment surgery or Intravitreal injections. Glaucomatous patients. Patients with corneal opacity which impairs good visualization.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 73 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: non-ILM peeling group<br>vitrectomy without ILM peeling is done to all cases | Other: Pars Plana Vitrectomy<br>* vitrectomy with and without ILM peeling<br>|
| Other: ILM peeling group<br>vitrectomy with ILM peeling is done to all cases | Other: Pars Plana Vitrectomy<br>* vitrectomy with and without ILM peeling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anatomical outcome | Rate of retinal reattachment using indirect ophthalmoscopy | 6 months follow up | 
| epiretinal membrane | incidence rate of epiretinal membrane formation after surgery in % percent | 6 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional outcome | visual functions using log Mar Best Corrected Visual Acuity (BCVA) | 6 months follow up | 
| superficial capillary density | measurement of percent (%) of superficial and deep capillary density using Optical Coherance Tomography Angiography | 6 months follow up | 
| multi-focal Electroretinogram | measurement of P1 amplitude | 6 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internal limiting membrane, multifocal electoretinogram (ERG), OCT-Angiography