NCT04767555

Brief Summary

Retinal detachment is associated with a substantial risk of re-detachment in 10-20% and to the formation of secondary epiretinal membranes in up to 15%. Relevant postoperative vision loss is encountered in many instances, primarily in consequence of macular involvement, but also secondarily due to postoperative complications, namely the formation of an epiretinal membrane and proliferative vitreoretinopathy. These mechanical reasons of influence can potentially be prevented by ILM peeling during reattachment surgery. This, however, is not a generally accepted standard of care during primary routine vitrectomy. Two groups suffering from primary retinal detachment will be compared: the first group will receive standard re-attachment vitrectomy surgery, whereas the second group will receive an identical vitrectomy surgery, but with additional ILM peeling. In this study, the investigators wish to assess the influence of ILM peeling on visual outcomes and postoperative complications over 12 months.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Feb 2022Jun 2026

First Submitted

Initial submission to the registry

February 17, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

February 23, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

December 8, 2025

Status Verified

November 1, 2025

Enrollment Period

4.1 years

First QC Date

February 17, 2021

Last Update Submit

December 1, 2025

Conditions

Retinal Detachment

Keywords

retinal detachmentILM-peeling

Outcome Measures

Primary Outcomes (1)

  • Number of patients developing secondary epiretinal membrane formation

    Clinically significant secondary epiretinal membrane formation requiring revision surgery

    12 months

Secondary Outcomes (4)

  • Rate of re-detachments in patients

    12 months

  • Best-corrected visual acuity

    12 months

  • Complication rates

    12 months

  • Surgical times

    minutes (0-300)

Study Arms (2)

ILM (inner limiting membrane) peeling

EXPERIMENTAL

ILM peeling adding to standard vitreous surgery in patients suffering from retinal detachment

Procedure: ILM (inner limiting membrane) peeling

No Peeling

NO INTERVENTION

standard vitreous surgery without ILM peeling in patients suffering from retinal detachment

Interventions

ILM (inner limiting membrane) peelingPROCEDURE

The standard technique for the removal of the inner limiting membrane is a dye-assisted ILM peeling established since 20 years as the standard of care to treat vision loss due to epiretinal membranes or macular holes in eyes with an otherwise stable retina, but not during retinal detachment surgery. Other dyes may show a stronger staining effect but since there is evidence of a potential toxicity of ICG the investigators use the well-tolerated and for this purpose approved trypan blue dye Membrane Blue ® (Dorc). This intervention will be performed in addition to standard vitreoretinal re-attachment surgery.

ILM (inner limiting membrane) peeling

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary rhegmatogenous retinal detachment
  • of legal age (18 years or older)
  • in case of bilateral retinal detachment, only the first-affected eye will be included

You may not qualify if:

  • pre-existing functional and morphological changes to the macula, hindering visual recovery (amblyopia, trauma, macular degeneration)
  • advanced retinal detachment with PVR stage C2 or more
  • eyes pre-operated within six months prior to the development of RD
  • state after any vitreoretinal surgery
  • state after complicated cataract surgery, including aphakia and anterior chamber lens implantation
  • patients with increased risk profiles
  • myopia magna (≥7 diopters)
  • advanced diabetic retinopathy
  • any chronic ocular or systemic inflammatory disease
  • any other proliferative systemic disease or condition associated with impaired wound healing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berner Augenklinik

Bern, Canton of Bern, 3007, Switzerland

Location

Related Publications (7)

  • Aras C, Arici C, Akar S, Muftuoglu G, Yolar M, Arvas S, Baserer T, Koyluoglu N. Peeling of internal limiting membrane during vitrectomy for complicated retinal detachment prevents epimacular membrane formation. Graefes Arch Clin Exp Ophthalmol. 2009 May;247(5):619-23. doi: 10.1007/s00417-008-1025-y. Epub 2008 Dec 24.

    PMID: 19107502BACKGROUND

  • Garweg JG, Bergstein D, Windisch B, Koerner F, Halberstadt M. Recovery of visual field and acuity after removal of epiretinal and inner limiting membranes. Br J Ophthalmol. 2008 Feb;92(2):220-4. doi: 10.1136/bjo.2007.131862. Epub 2007 Nov 30.

    PMID: 18055572BACKGROUND

  • Garweg JG, Deiss M, Pfister IB, Gerhardt C. IMPACT OF INNER LIMITING MEMBRANE PEELING ON VISUAL RECOVERY AFTER VITRECTOMY FOR PRIMARY RHEGMATOGENOUS RETINAL DETACHMENT INVOLVING THE FOVEA. Retina. 2019 May;39(5):853-859. doi: 10.1097/IAE.0000000000002046.

    PMID: 29394235BACKGROUND

  • Hohn F, Kretz FT, Pavlidis M. [Primary vitrectomy with peeling of the internal limiting membrane under decaline: a promising surgical maneuver for treatment of total and subtotal retinal detachment]. Ophthalmologe. 2014 Sep;111(9):882-6. doi: 10.1007/s00347-014-3158-1. German.

    PMID: 25204530BACKGROUND

  • Kodjikian L, Richter T, Halberstadt M, Beby F, Flueckiger F, Boehnke M, Garweg JG. Toxic effects of indocyanine green, infracyanine green, and trypan blue on the human retinal pigmented epithelium. Graefes Arch Clin Exp Ophthalmol. 2005 Sep;243(9):917-25. doi: 10.1007/s00417-004-1121-6. Epub 2005 Apr 15.

    PMID: 15834606BACKGROUND

  • Koerner F, Garweg J. Advances in the management of vitreomacular traction syndrome and macular hole. Dev Ophthalmol. 1997;29:15-29. doi: 10.1159/000060723. No abstract available.

    PMID: 9413690BACKGROUND

  • Odrobina D, Bednarski M, Cisiecki S, Michalewska Z, Kuhn F, Nawrocki J. Internal limiting membrane peeling as prophylaxis of macular pucker formation in eyes undergoing retinectomy for severe proliferative vitreoretinopathy. Retina. 2012 Feb;32(2):226-31. doi: 10.1097/IAE.0b013e31821a12e9.

    PMID: 21878849BACKGROUND

MeSH Terms

Conditions

Retinal Detachment

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Justus G Garweg, Prof. Dr.

    Berner Augenklinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 23, 2021

Study Start

February 23, 2022

Primary Completion

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 8, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)