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

Not Applicable

Completed

• Conditions: Retinal Detachment
• Interventions: Other: Pars Plana Vitrectomy

• Registration Number: NCT04139811
• Lead Sponsor: Minia University

Brief Summary

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

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

Study Timeline

• Study Start: 2017-03-15
• Primary Completion: 2019-07-15
• Study Completion: 2019-08-15
• Study First Submitted: 2019-09-24
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-23
• Last Update Submitted: 2019-10-23
• Study First Posted: 2019-10-25
• Last Update Posted: 2019-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-ILM peeling group	Pars Plana Vitrectomy	vitrectomy without ILM peeling is done to all cases
ILM peeling group	Pars Plana Vitrectomy	vitrectomy with ILM peeling is done to all cases

Primary Outcome Measures

Name	Time	Method
epiretinal membrane	6 months follow up	incidence rate of epiretinal membrane formation after surgery in % percent
anatomical outcome	6 months follow up	Rate of retinal reattachment using indirect ophthalmoscopy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Minia UNiversity hospital; 🇪🇬 Minya, Minia, Egypt