Impact of ILM Peeling in RRD/ I-Peel

Launched by BERNER AUGENKLINIK · Feb 22, 2021

Keywords

ClinConnect Summary

The I-Peel study is testing whether peeling off a thin inner layer of the retina (the ILM) during eye surgery to fix a retinal detachment helps patients in the long run. Participants are randomly assigned to two groups: one gets the standard retina reattachment surgery plus ILM peeling, and the other gets the same surgery without ILM peeling. The main question is whether ILM peeling reduces the chance of a scar-like membrane forming on the retina within a year that would require another surgery. The study also looks at vision, any complications, how long the surgery takes, and the overall safety of the procedure.

Eligible participants are adults 18 and older with a first-time, primary rhegmatogenous retinal detachment who do not have certain eye problems that could limit recovery (for example, advanced macular disease, prior vitreoretinal surgery, or very severe retinal scarring). About 250 people are planned to enroll at the Berner Augenklinik in Bern, Switzerland, with results expected after 2026. The trial is randomized and open-label (participants and doctors know which approach is used). Key outcomes include re-detachment rates, changes in best-cavailable visual acuity, complication rates, and the time the surgery takes, all followed for 12 months.

Gender

ALL

Eligibility criteria

• 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