Internal Limiting Membrane Peeling in Retinal Detachment Surgery

Study Overview
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Brief Summary
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Despite advances in surgical techniques over the recent decades, proliferative vitreoretinopathy (PVR) remains the main obstacle to successful rhegmatogenous retinal detachment (RRD) repair, accounting for nearly 75% of all primary surgical failures. It is characterized by the growth and contraction of cellular membranes within the vitreous cavity and on both surfaces of the detached retina as well as intraretinal fibrosis. The Retina Society classification, modified in 1991 and currently the most widely used, divided PVR into three grades. Grade A is limited to the presence of vitreous haze and pigment clumps. Grade B includes rolled or irregular edges of tear and/or inner retinal surface wrinkling with possible retinal stiffness and vessel tortuosity. Grade C is defined as the presence of full-thickness fixed retinal folds and is further subdivided based on the number of hours involved and the location. Recently, Foveau et al., in a retrospective comparative case series, have demonstrated that performing internal limiting membrane (ILM) peeling during RRD surgery may increase the anatomical success rate for this indication. The aim of this multi-center, prospective, randomized controlled clinical trial study is to evaluate the effectiveness of ILM peeling on surgical outcomes in patients with primary macula-off RRD complicated by grade B PVR.

Detailed Description
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Despite advances in surgical techniques over the recent decades, proliferative vitreoretinopathy (PVR) remains the main obstacle to successful rhegmatogenous retinal detachment (RRD) repair, accounting for nearly 75% of all primary surgical failures. It is characterized by the growth and contraction of cellular membranes within the vitreous cavity and on both surfaces of the detached retina as well as intraretinal fibrosis. The Retina Society classification, modified in 1991 and currently the most widely used, divided PVR into three grades. Grade A is limited to the presence of vitreous haze and pigment clumps. Grade B includes rolled or irregular edges of tear and/or inner retinal surface wrinkling with possible retinal stiffness and vessel tortuosity. Grade C is defined as the presence of full-thickness fixed retinal folds and is further subdivided based on the number of hours involved and the location. Grade B PVR is thought to represent an immature form of PVR with a definite potential for progression to further stages of PVR. Specific treatment for moderate PVR seems to be essential to halt the disease process and to reduce the risk of postoperative re-detachment. However, there is currently no consensus regarding the management of grade PVR. In macula-off RRD, vitrectomy with gas tamponade is often used as a primary option, with a retinal reattachment rate of 60%. Recently, Foveau et al., in a retrospective comparative case series, have demonstrated that performing internal limiting membrane (ILM) peeling during RRD surgery may increase the anatomical success rate for this indication. The aim of this multi-center, prospective, randomized controlled clinical trial study is to evaluate the effectiveness of ILM peeling on surgical outcomes in patients with primary macula-off RRD complicated by grade B PVR.

Official Title
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Internal Limiting Membrane Peeling in Macula-off Retinal Detachment With Grade B Proliferative Vitreoretinopathy

Conditions
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Retinal Detachment, Proliferative Vitreoretinopathy

Intervention / Treatment
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* Procedure: Control group
* Procedure: Intervention group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years old With macula-off retinal detachment complicated by grade B proliferative vitreoretinopathy Exclusion Criteria: Underage patients History of retinal detachment History of intraocular surgery (except for cataract surgery) Traumatic retinal detachment Macular hole-associated retinal detachment Concurrent macular disease (diabetic maculopathy, age-related macular degeneration)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Other: Control group<br>The internal limiting membrane is not removed | Procedure: Control group<br>* Vitrectomy and gas tamponade without internal limiting membrane peeling<br>|
| Other: Intervention group<br>The internal limiting membrane of the posterior pole is removed | Procedure: Intervention group<br>* Vitrectomy, internal limiting membrane peeling and gas tamponade<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary anatomical success rate | Primary retinal reattachment rate | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcomes #1 | Visual acuity (Logarithm of the Minimum Angle of Resolution) | 12 months after surgery | 
| Functional outcomes #2 | Degree of metamorphopsia (M-CHARTS) | 12 months after surgery | 
| Anatomical outcomes #1 | Integrity of the photoreceptor layer on Spectral Domain Optical Coherence Tomography | 12 months after surgery | 
| Anatomical outcomes #2 | Incidence of epiretinal membrane | 12 months after surgery | 
| Anatomical outcomes #3 | Incidence of cystoid macular edema | 12 months after surgery | 
| Anatomical outcomes #4 | Incidence of DONFL appearance | 12 months after surgery | 
| Functional outcomes #3 | Retinal sensitivity on microperimetry testing | 12 months after surgery |