- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07346560
1ry Versus 2ry ILM Peeling in RD
January 15, 2026 updated by: Alaa Abdalsadek Ahmed Sinjab, Sohag University
Primary Versus Secondary Internal Limiting Membrane Peeling in Uncomplicated Retinal Detachment
Patients with uncomplicated rhegmatogenous retinal detachment will be recruited.
All eyes will underwent 23G PPV with silicon oil tamponade.
The eyes will be classified into two groups according to the timing of ILM peeling.
Group A, ILM peelin will be performed during the first intervention, while in group B, it will be done at the time of silicon oil extraction.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alaa Sinjab, MD
- Phone Number: +20-01064037382
- Email: alaa.abdelsadek@med.sohag.edu.eg
Study Locations
-
-
Sohag Governorate
-
Sohag, Sohag Governorate, Egypt, 82511
- Recruiting
- Sohag faculty of medicine
-
Contact:
- Alaa Sinjab
- Phone Number: +20-01064037382
- Email: alaa.abdelsadek@med.sohag.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A (Primary ILM peeling)
ILM peeling during PPV for rRD
|
ILM peeling during the 1st surgical intervention for rRD
|
|
Active Comparator: Group B
ILM peeling at time of silicon oil extraction
|
ILM peeling is delayed for the time of silicon oil extraction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of complications
Time Frame: From enrollment till 3 months postoperative
|
From enrollment till 3 months postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
January 6, 2026
First Submitted That Met QC Criteria
January 15, 2026
First Posted (Estimated)
January 16, 2026
Study Record Updates
Last Update Posted (Estimated)
January 16, 2026
Last Update Submitted That Met QC Criteria
January 15, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-25-12-8PD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All IPD will be available for other researchers.
IPD Sharing Time Frame
From enrollment and forever.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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