Study Stopped
Peeling of the internal limiting membrane has shown risks to leave full thickness retinal defects
Peeling of the Internal Limiting Membrane During Primary Vitrectomy for Retinal Detachment Repair
Effect of Peeling of the Internal Limiting Membrane on Vision Results After Primary Vitrectomy for Retinal Detachment Repair
1 other identifier
interventional
21
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedFirst Submitted
Initial submission to the registry
February 22, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedApril 15, 2026
February 1, 2026
5.8 years
February 22, 2026
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
EXPERIMENTALNo Peeling
ACTIVE COMPARATORInterventions
during primary vitrectomy for retinal detachment repair additional ILM-Peeling is performed
during primary vitrectomy for retinal detachment repair no additional ILM-Peeling is performed
Eligibility Criteria
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
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
Condition Hierarchy (Ancestors)
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