Ignite Creation Date:
2024-05-06 @ 6:05 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05538156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-09-13
First Post:
2022-09-09
Brief Title:
Internal Limiting Membrane Peeling in Retinal Detachment Surgery
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Internal Limiting Membrane Peeling in Macula-off Retinal Detachment With Grade B Proliferative Vitreoretinopathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPURITY
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 andor 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
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 andor 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None