NCT07346560

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Dec 2025Mar 2027

Study Start

First participant enrolled

December 15, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

January 6, 2026

Last Update Submit

January 15, 2026

Conditions

Retinal Detachment RhegmatogenousILM Peeling

Keywords

Retinal detachmentILM peelingProliferative vitroretinopathy

Outcome Measures

Primary Outcomes (1)

  • Incidence of complications

    From enrollment till 3 months postoperative

Study Arms (2)

Group A (Primary ILM peeling)

ACTIVE COMPARATOR

ILM peeling during PPV for rRD

Procedure: Primary ILM peeling

Group B

ACTIVE COMPARATOR

ILM peeling at time of silicon oil extraction

Procedure: Secondary ILM peeling

Interventions

Primary ILM peelingPROCEDURE

ILM peeling during the 1st surgical intervention for rRD

Group A (Primary ILM peeling)
Secondary ILM peelingPROCEDURE

ILM peeling is delayed for the time of silicon oil extraction

Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with uncomplicated rhegmatogenous retinal detcahment.

You may not qualify if:

  • PVR
  • Recurrent RD
  • Tractional RD
  • Macular hole RD
  • Scleral buckling is indicated
  • Macular scarring
  • Previous PPV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag Faculty of Medicine

Sohag, Sohag Governorate, 82511, Egypt

RECRUITING

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Central Study Contacts

Alaa Sinjab, MD

CONTACT

+20-01064037382alaa.abdelsadek@med.sohag.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 16, 2026

Study Start

December 15, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

All IPD will be available for other researchers.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
From enrollment and forever.

Locations

EG(1)