An interventional study of Control group and Intervention group in Retinal Detachment and Proliferative Vitreoretinopathy, sponsored by Central Hospital, Nancy, France. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-13.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Treatment
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.
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.
199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.
This study's planned enrollment of 126 is above the median of 50 across 132 interventional studies indexed under Retinal Detachment.
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Exclusion Criteria:
The internal limiting membrane is not removed
Procedure: Control group
The internal limiting membrane of the posterior pole is removed
Procedure: Intervention group
Vitrectomy and gas tamponade without internal limiting membrane peeling
Vitrectomy, internal limiting membrane peeling and gas tamponade
Primary anatomical success rate
Primary retinal reattachment rate
Time frame: 12 months after surgery
Functional outcomes #1
Visual acuity (Logarithm of the Minimum Angle of Resolution)
Time frame: 12 months after surgery
Functional outcomes #2
Degree of metamorphopsia (M-CHARTS)
Time frame: 12 months after surgery
Anatomical outcomes #1
Integrity of the photoreceptor layer on Spectral Domain Optical Coherence Tomography
Time frame: 12 months after surgery
Anatomical outcomes #2
Incidence of epiretinal membrane
Time frame: 12 months after surgery
Anatomical outcomes #3
Incidence of cystoid macular edema
Time frame: 12 months after surgery
Anatomical outcomes #4
Incidence of DONFL appearance
Time frame: 12 months after surgery
Functional outcomes #3
Retinal sensitivity on microperimetry testing
Time frame: 12 months after surgery
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France →