Internal Limiting Membrane Peeling in Retinal Detachment Surgery
- Conditions
- Retinal DetachmentProliferative Vitreoretinopathy
- Interventions
- Procedure: Control groupProcedure: Intervention group
- Registration Number
- NCT05538156
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 126
- Patients older than 18 years old
- With macula-off retinal detachment complicated by grade B proliferative vitreoretinopathy
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Control group The internal limiting membrane is not removed Intervention group Intervention group The internal limiting membrane of the posterior pole is removed
- Primary Outcome Measures
Name Time Method Primary anatomical success rate 12 months after surgery Primary retinal reattachment rate
- Secondary Outcome Measures
Name Time Method Functional outcomes #2 12 months after surgery Degree of metamorphopsia (M-CHARTS)
Anatomical outcomes #2 12 months after surgery Incidence of epiretinal membrane
Functional outcomes #1 12 months after surgery Visual acuity (Logarithm of the Minimum Angle of Resolution)
Anatomical outcomes #1 12 months after surgery Integrity of the photoreceptor layer on Spectral Domain Optical Coherence Tomography
Anatomical outcomes #3 12 months after surgery Incidence of cystoid macular edema
Anatomical outcomes #4 12 months after surgery Incidence of DONFL appearance
Functional outcomes #3 12 months after surgery Retinal sensitivity on microperimetry testing