Peeling of the Internal Limiting Membrane During Primary... | NCT07438210

Studies
Peeling of the Internal Limiting Membrane During Primary Vitrectomy for Retinal Detachment Repair

NCT07438210

Sponsor

Vienna Institute for Research in Ocular Surgery

Status

Terminated

Last Update Posted

Apr 15, 2026Actual

Enrollment

21Actual

Phase

Not Applicable

Conditions

Retinal Detachment

Interventions

ILM-Peeling
No Peeling

Countries

Austria

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

Feb 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Peeling of the internal limiting membrane has shown risks to leave full thickness retinal defects

Expanded Access Info

Start Date

Apr 3, 2019Actual

Primary Completion Date

Jan 1, 2025Actual

Completion Date

Jan 1, 2025Actual

First Submitted Date

Feb 22, 2026

First Submission Date that Met QC Criteria

Feb 22, 2026

First Posted Date

Feb 27, 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

Apr 12, 2026

Last Update Posted Date

Apr 15, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prim. Prof. Dr. Oliver Findl, MBA, Head of department, Vienna Institute for Research in Ocular SurgeryPrincipal Investigator

Lead Sponsor

Vienna Institute for Research in Ocular SurgeryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Primary vitrectomy for retinal detachment repair is one of the current methods for surgical treatment of retinal detachment. Additional peeling of the internal limiting membrane (ILM) was reported to successfully prevent development of epiretinal membranes after surgery. The aim of the study is to examine the effect of ILM-Peeling on visual acuity outcomes and on occurrence of postoperative epiretinal membranes.

Detailed Description

Retinal detachment is a disorder, usually caused by peripheral retinal breaks, that leads to severe decrease in vision in untreated cases. Primary vitrectomy for retinal detachment repair is one of the current methods for surgical treatment of retinal detachment. Recent retrospective studies support the hypothesis, that peeling of the internal limiting membrane (ILM) is beneficial on postoperative visual acuity and lower rates of occurrence of epiretinal membranes after surgery [Forlini et al. 2018].

The aim of the study is to examine the effect of ILM-Peeling on visual acuity outcomes and on occurrence of postoperative epiretinal membranes.

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

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ILM-Peeling	Experimental		Procedure: ILM-Peeling
No Peeling	Active Comparator		Procedure: No Peeling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ILM-Peeling	Procedure	during primary vitrectomy for retinal detachment repair additional ILM-Peeling is performed	ILM-Peeling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visual acuity		from enrollment to the end of follow-up at 4 years after surgery

Secondary Outcomes

Measure	Description	Time Frame
occurrence of epiretinal membranes		from enrollment to the follow-up at 4 years after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

retinal detachment
age: 18 or older
written informed consent for surgery and participation in the study prior to surgery

Exclusion Criteria:

pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

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

Facility	Status	City	State	ZIP	Country	Contacts
VIROS		Vienna		1140	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28723849	Background	Forlini M, Date P, Ferrari LM, Lorusso M, Lecce G, Verdina T, Neri G, Benatti C, Rossini P, Bratu A, D'Eliseo D, Ferrari TM, Cavallini GM. COMPARATIVE ANALYSIS OF RETINAL REATTACHMENT SURGERY WITH OR WITHOUT INTERNAL LIMITING MEMBRANE PEELING TO PREVENT POSTOPERATIVE MACULAR PUCKER. Retina. 2018 Sep;38(9):1770-1776. doi: 10.1097/IAE.0000000000001775.

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases