NCT07438210

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.

Trial Health

57
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Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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 Start

First participant enrolled

April 3, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

April 15, 2026

Status Verified

February 1, 2026

Enrollment Period

5.8 years

First QC Date

February 22, 2026

Last Update Submit

April 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • visual acuity

    from enrollment to the end of follow-up at 4 years after surgery

Secondary Outcomes (1)

  • occurrence of epiretinal membranes

    from enrollment to the follow-up at 4 years after surgery

Study Arms (2)

ILM-Peeling

EXPERIMENTAL
Procedure: ILM-Peeling

No Peeling

ACTIVE COMPARATOR
Procedure: No Peeling

Interventions

ILM-PeelingPROCEDURE

during primary vitrectomy for retinal detachment repair additional ILM-Peeling is performed

ILM-Peeling
No PeelingPROCEDURE

during primary vitrectomy for retinal detachment repair no additional ILM-Peeling is performed

No Peeling

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VIROS

Vienna, 1140, Austria

Location

Related Publications (1)

  • 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.

    PMID: 28723849BACKGROUND

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department

Study Record Dates

First Submitted

February 22, 2026

First Posted

February 27, 2026

Study Start

April 3, 2019

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

April 15, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations