1ry Versus 2ry ILM Peeling in RD | NCT07346560

Studies
1ry Versus 2ry ILM Peeling in RD

NCT07346560

Sponsor

Sohag University

Status

Recruiting

Last Update Posted

Jan 16, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Retinal Detachment Rhegmatogenous
ILM Peeling

Interventions

Primary ILM peeling
Secondary ILM peeling

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2025Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Mar 2027Estimated

First Submitted Date

Jan 6, 2026

First Submission Date that Met QC Criteria

Jan 15, 2026

First Posted Date

Jan 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2026

Last Update Posted Date

Jan 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Primary ILM peeling	Procedure	ILM peeling during the 1st surgical intervention for rRD	Group A (Primary ILM peeling)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of complications		From enrollment till 3 months postoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alaa Sinjab, MD	Contact	+20-01064037382		alaa.abdelsadek@med.sohag.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag Faculty of Medicine	Recruiting	Sohag	Sohag Governorate	82511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All IPD will be available for other researchers.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

From enrollment and forever.

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012163	Retinal Detachment

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided