NCT04767555

Impact of ILM Peeling in RRD/ I-Peel

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Berner Augenklinik · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Retinal Detachment

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-23
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2021-02-23
• Last updated: 2025-12-08

Locations

1 site across 1 country: Switzerland