Impact of ILM Peeling in RRD/ I-Peel (I-Peel)

Impact of ILM Peeling on Functional and Anatomic Outcomes of Vitrectomy for Primary Rhegmatogenous Retinal Detachment - the I-Peel Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Retinal Detachment
• Intervention / Treatment: Procedure: ILM (inner limiting membrane) peeling

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Bern
    • Bern, Canton of Bern, Switzerland, 3007
      • Berner Augenklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 106 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ILM (inner limiting membrane) peeling; ILM peeling adding to standard vitreous surgery in patients suffering from retinal detachment	Procedure: ILM (inner limiting membrane) peeling; 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.
No Intervention: No Peeling; standard vitreous surgery without ILM peeling in patients suffering from retinal detachment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients developing secondary epiretinal membrane formation	Clinically significant secondary epiretinal membrane formation requiring revision surgery	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of re-detachments in patients	Revision surgery due to re-detachment independently of secondary epiretinal membrane formation	12 months
Best-corrected visual acuity	Change in best-corrected visual acuity	12 months
Complication rates	Intra- and postoperative complication rates including PVR	12 months
Surgical times	How long does the surgery take	minutes (0-300)

Collaborators and Investigators

• Sponsor: Berner Augenklinik
• Investigators: Principal Investigator: Justus G Garweg, Prof. Dr., Berner Augenklinik

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: retinal detachment; ILM-peeling
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Detachment; Digestive System and Oral Physiological Phenomena; Dental Physiological Phenomena; Tooth Exfoliation
• Other Study ID Numbers: I-Peel 2021-00027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No