Primary versus secondary ILM peeling for rhegmatogenous retinal detachment
Primary Versus Secondary Internal Limiting Membrane Peeling in Uncomplicated Retinal Detachment
This trial will test whether peeling the internal limiting membrane (ILM) during the first vitrectomy or waiting until silicone oil removal leads to better vision and fewer complications for people with uncomplicated rhegmatogenous retinal detachment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag, Sohag Governorate) |
| Trial ID | NCT07346560 on ClinicalTrials.gov |
What this trial studies
Patients with uncomplicated rhegmatogenous retinal detachment will all undergo 23-gauge pars plana vitrectomy with silicone oil tamponade and then be assigned to one of two groups based on when the ILM is peeled. Group A will have ILM peeling during the initial vitrectomy, while Group B will have ILM peeling later at the time of silicone oil extraction. Outcomes will include anatomical reattachment, visual acuity, rates of epiretinal membrane or proliferative vitreoretinopathy, and need for further surgery. The comparison aims to determine whether timing of ILM peeling affects vision and complication rates.
Who should consider this trial
Good fit: Ideal candidates are people with uncomplicated rhegmatogenous retinal detachment who have not had prior vitrectomy and do not have proliferative vitreoretinopathy, macular scarring, or other exclusionary conditions.
Not a fit: Patients with PVR, recurrent or tractional retinal detachment, macular hole detachment, those needing scleral buckle, macular scarring, or prior PPV are excluded and unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the finding could improve final visual outcomes and reduce reoperations or membrane-related complications after repair of uncomplicated retinal detachment.
How similar studies have performed: Previous studies have examined ILM peeling to reduce epiretinal membranes and PVR with mixed results, but head-to-head comparisons of primary versus secondary peeling are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with uncomplicated rhegmatogenous retinal detcahment. Exclusion Criteria: * PVR * Recurrent RD * Tractional RD * Macular hole RD * Scleral buckling is indicated * Macular scarring * Previous PPV
Where this trial is running
Sohag, Sohag Governorate
- Sohag Faculty of Medicine — Sohag, Sohag Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Alaa Sinjab, MD
- Email: alaa.abdelsadek@med.sohag.edu.eg
- Phone: +20-01064037382
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.