About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients older than 18 years old
With macula-off retinal detachment complicated by grade B proliferative vitreoretinopathy
Disqualifiers
Underage patients
History of retinal detachment
History of intraocular surgery (except for cataract surgery)
Traumatic retinal detachment
Trial design
Parallel
Treatments tested in this trial
Control group
Procedure/SurgeryVitrectomy and gas tamponade without internal limiting membrane peeling
Intervention group
Procedure/SurgeryVitrectomy, internal limiting membrane peeling and gas tamponade
Treatment groups
Trial outcomes
Primary outcomes
Primary anatomical success rate
Primary retinal reattachment rate
Secondary outcomes
Functional outcomes #1
Visual acuity (Logarithm of the Minimum Angle of Resolution)
Functional outcomes #2
Degree of metamorphopsia (M-CHARTS)
Anatomical outcomes #1
Integrity of the photoreceptor layer on Spectral Domain Optical Coherence Tomography
Anatomical outcomes #2
Incidence of epiretinal membrane
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: