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Retinal DetachmentI-PeelNCT04767555

Impact of ILM Peeling in RRD/ I-Peel

A study testing ILM (inner limiting membrane) peeling in people with Retinal Detachment, run by Berner Augenklinik at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 110 years
Conditions the study is for
Retinal Detachment
What is being tested?
ILM (inner limiting membrane) peeling
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteSwitzerland
Study dates
23 Feb 2022to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Berner Augenklinik

    Bern, Canton of Bern, 3007

Other trials in Switzerland

About this study

Official title: 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.

Being tested
ILM (inner limiting membrane) peeling
Keywords
retinal detachment, ILM-peeling
Medical subject headings
Retinal Detachment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ILM (inner limiting membrane) peelingProcedure or surgery

    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.

Study groups in NCT04767555
Study groupRoleWhat they receive
ILM (inner limiting membrane) peelingExperimentalILM peeling adding to standard vitreous surgery in patients suffering from retinal detachment
Receives: Procedure: ILM (inner limiting membrane) peeling
No PeelingNo interventionstandard vitreous surgery without ILM peeling in patients suffering from retinal detachment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients developing secondary epiretinal membrane formation

    Clinically significant secondary epiretinal membrane formation requiring revision surgery

    Measured: 12 months

Secondary outcomes (4)

  1. Rate of re-detachments in patients

    Revision surgery due to re-detachment independently of secondary epiretinal membrane formation

    Measured: 12 months

  2. Best-corrected visual acuity

    Change in best-corrected visual acuity

    Measured: 12 months

  3. Complication rates

    Intra- and postoperative complication rates including PVR

    Measured: 12 months

  4. Surgical times

    How long does the surgery take

    Measured: minutes (0-300)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2021
  2. Study start23 Feb 2022
  3. Primary completionApr 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04767555
Sponsor's protocol ID
I-Peel 2021-00027
Acronym
I-Peel
Status last verified
Nov 2025
First submitted
17 Feb 2021
Last updated
8 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 19107502

  • 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.

    PubMed 18055572

  • 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.

    PubMed 29394235

  • 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.

    PubMed 25204530

  • 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.

    PubMed 15834606

  • 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.

    PubMed 9413690

  • 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.

    PubMed 21878849

Questions about this trial

What is this clinical trial studying?

A study testing ILM (inner limiting membrane) peeling in people with Retinal Detachment, run by Berner Augenklinik at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients developing secondary epiretinal membrane formation (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04767555, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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