Impact of ILM Peeling in RRD/ I-Peel

Study Overview
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Brief Summary
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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.

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

Conditions
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Retinal Detachment

Intervention / Treatment
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* Procedure: ILM (inner limiting membrane) peeling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ILM (inner limiting membrane) peeling<br>ILM peeling adding to standard vitreous surgery in patients suffering from retinal detachment | Procedure: ILM (inner limiting membrane) peeling<br>* 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.<br>|
| No Intervention: No Peeling<br>standard vitreous surgery without ILM peeling in patients suffering from retinal detachment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients developing secondary epiretinal membrane formation | Clinically significant secondary epiretinal membrane formation requiring revision surgery | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinal detachment, ILM-peeling