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Active, Not Recruiting

NCT Number: NCT04767555

Impact of ILM Peeling in RRD/ I-Peel

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Berner Augenklinik

Bern, Canton of Bern, 3007, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ILM (inner limiting membrane) peeling

Procedure

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.

Primary outcomes

  1. Number of patients developing secondary epiretinal membrane formation

    Time frame: 12 months

    Clinically significant secondary epiretinal membrane formation requiring revision surgery

Secondary outcomes

  1. Rate of re-detachments in patients

    Time frame: 12 months

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

  2. Best-corrected visual acuity

    Time frame: 12 months

    Change in best-corrected visual acuity

  3. Complication rates

    Time frame: 12 months

    Intra- and postoperative complication rates including PVR

  4. Surgical times

    Time frame: minutes (0-300)

    How long does the surgery take

Sponsors and collaborators

Lead sponsor

Berner Augenklinik

Other

Registry information

Official study title

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

Acronym: I-Peel

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2021
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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