Impact of ILM Peeling in RRD/ I-Peel

Not Applicable

• Conditions: Retinal Detachment
• Interventions: Procedure: ILM (inner limiting membrane) peeling

• Registration Number: NCT04767555
• Lead Sponsor: Berner Augenklinik

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-23
• Study Start: 2022-02-23
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2026-04
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ILM (inner limiting membrane) peeling	ILM (inner limiting membrane) peeling	ILM peeling adding to standard vitreous surgery in patients suffering from retinal detachment

Primary Outcome Measures

Name	Time	Method
Number of patients developing secondary epiretinal membrane formation	12 months	Clinically significant secondary epiretinal membrane formation requiring revision surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Berner Augenklinik; 🇨🇭 Bern, Switzerland