Retinal Detachment RhegmatogenousNCT07346560
1ry Versus 2ry ILM Peeling in RD
A study testing Primary ILM peeling and Secondary ILM peeling in people with Retinal Detachment Rhegmatogenous and ILM Peeling, run by Sohag University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment Rhegmatogenous, ILM Peeling
- What is being tested?
- Primary ILM peeling and Secondary ILM peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with uncomplicated rhegmatogenous retinal detcahment.
Who cannot join
- PVR
- Recurrent RD
- Tractional RD
- Macular hole RD
- Scleral buckling is indicated
- Macular scarring
- Previous PPV
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag Faculty of Medicine
Sohag, Sohag Governorate, 82511
Alaa Sinjab, +20-01064037382, alaa.abdelsadek@med.sohag.edu.eg
About this study
Official title: 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.
- Conditions
- Retinal Detachment Rhegmatogenous, ILM Peeling
- Being tested
- Primary ILM peeling, Secondary ILM peeling
- Keywords
- Retinal detachment, ILM peeling, Proliferative vitroretinopathy
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary ILM peelingProcedure or surgery
ILM peeling during the 1st surgical intervention for rRD
Secondary ILM peelingProcedure or surgery
ILM peeling is delayed for the time of silicon oil extraction
| Study group | Role | What they receive |
|---|---|---|
| Group A (Primary ILM peeling) | Active comparator | ILM peeling during PPV for rRD Receives: Procedure: Primary ILM peeling |
| Group B | Active comparator | ILM peeling at time of silicon oil extraction Receives: Procedure: Secondary ILM peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications
Measured: From enrollment till 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start15 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Detachment RhegmatogenousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abdalsadek Ahmed Sinjab, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346560
- Sponsor's protocol ID
- Soh-Med-25-12-8PD
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be available for other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Versus Secondary Internal Limiting Membrane Peeling in Uncomplicated Retinal Detachment
- ClinicalTrials.gov ID
- NCT07346560
- Acronym / sponsor ID
- Soh-Med-25-12-8PD
- Conditions
- Retinal Detachment Rhegmatogenous, ILM Peeling
- Keywords
- Retinal detachment, ILM peeling, Proliferative vitroretinopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Primary ILM peeling) | Active comparator | Procedure: Primary ILM peelingILM peeling during PPV for rRD |
| Group B | Active comparator | Procedure: Secondary ILM peelingILM peeling at time of silicon oil extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with uncomplicated rhegmatogenous retinal detcahment.
Key exclusion criteria (7 listed)
- PVR
- Recurrent RD
- Tractional RD
- Macular hole RD
- Scleral buckling is indicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary ILM peelingILM peeling during the 1st surgical intervention for rRD | Procedure or surgery | Group A (Primary ILM peeling) |
| Secondary ILM peelingILM peeling is delayed for the time of silicon oil extraction | Procedure or surgery | Group B |
Primary outcome
Incidence of complications
Time frame: From enrollment till 3 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Yes. All IPD will be available for other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary ILM peeling and Secondary ILM peeling in people with Retinal Detachment Rhegmatogenous and ILM Peeling, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa Sinjab, MD (+20-01064037382, alaa.abdelsadek@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complications (time frame: From enrollment till 3 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.