Internal Limiting Membrane Peeling in Retinal Detachment Surgery (IMPURITY)
Primary Purpose
Retinal Detachment, Proliferative Vitreoretinopathy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Control group
Intervention group
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Detachment
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Control group
Intervention group
Arm Description
The internal limiting membrane is not removed
The internal limiting membrane of the posterior pole is removed
Outcomes
Primary Outcome Measures
Primary anatomical success rate
Primary retinal reattachment rate
Secondary Outcome Measures
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
Anatomical outcomes #3
Incidence of cystoid macular edema
Anatomical outcomes #4
Incidence of DONFL appearance
Functional outcomes #3
Retinal sensitivity on microperimetry testing
Full Information
NCT ID
NCT05538156
First Posted
September 9, 2022
Last Updated
September 9, 2022
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT05538156
Brief Title
Internal Limiting Membrane Peeling in Retinal Detachment Surgery
Acronym
IMPURITY
Official Title
Internal Limiting Membrane Peeling in Macula-off Retinal Detachment With Grade B Proliferative Vitreoretinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment, Proliferative Vitreoretinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Other
Arm Description
The internal limiting membrane is not removed
Arm Title
Intervention group
Arm Type
Other
Arm Description
The internal limiting membrane of the posterior pole is removed
Intervention Type
Procedure
Intervention Name(s)
Control group
Intervention Description
Vitrectomy and gas tamponade without internal limiting membrane peeling
Intervention Type
Procedure
Intervention Name(s)
Intervention group
Intervention Description
Vitrectomy, internal limiting membrane peeling and gas tamponade
Primary Outcome Measure Information:
Title
Primary anatomical success rate
Description
Primary retinal reattachment rate
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Functional outcomes #1
Description
Visual acuity (Logarithm of the Minimum Angle of Resolution)
Time Frame
12 months after surgery
Title
Functional outcomes #2
Description
Degree of metamorphopsia (M-CHARTS)
Time Frame
12 months after surgery
Title
Anatomical outcomes #1
Description
Integrity of the photoreceptor layer on Spectral Domain Optical Coherence Tomography
Time Frame
12 months after surgery
Title
Anatomical outcomes #2
Description
Incidence of epiretinal membrane
Time Frame
12 months after surgery
Title
Anatomical outcomes #3
Description
Incidence of cystoid macular edema
Time Frame
12 months after surgery
Title
Anatomical outcomes #4
Description
Incidence of DONFL appearance
Time Frame
12 months after surgery
Title
Functional outcomes #3
Description
Retinal sensitivity on microperimetry testing
Time Frame
12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Baptiste CONART, Prof
Phone
+33383155101
Email
jbconart@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste CONART, Prof
Organizational Affiliation
Brabois Hospital, Nancy, France
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31126280
Citation
Borowicz D, Nowomiejska K, Nowakowska D, Brzozowska A, Toro MD, Avitabile T, Junemann AG, Rejdak R. Functional and morphological results of treatment of macula-on and macula-off rhegmatogenous retinal detachment with pars plana vitrectomy and sulfur hexafluoride gas tamponade. BMC Ophthalmol. 2019 May 24;19(1):118. doi: 10.1186/s12886-019-1120-3.
Results Reference
result
PubMed Identifier
7488586
Citation
Charteris DG. Proliferative vitreoretinopathy: pathobiology, surgical management, and adjunctive treatment. Br J Ophthalmol. 1995 Oct;79(10):953-60. doi: 10.1136/bjo.79.10.953. No abstract available.
Results Reference
result
PubMed Identifier
29299741
Citation
Eissa MGAM, Abdelhakim MASE, Macky TA, Khafagy MM, Mortada HA. Functional and structural outcomes of ILM peeling in uncomplicated macula-off RRD using microperimetry & en-face OCT. Graefes Arch Clin Exp Ophthalmol. 2018 Feb;256(2):249-257. doi: 10.1007/s00417-017-3875-7. Epub 2018 Jan 3.
Results Reference
result
PubMed Identifier
30024983
Citation
Fallico M, Russo A, Longo A, Pulvirenti A, Avitabile T, Bonfiglio V, Castellino N, Cennamo G, Reibaldi M. Internal limiting membrane peeling versus no peeling during primary vitrectomy for rhegmatogenous retinal detachment: A systematic review and meta-analysis. PLoS One. 2018 Jul 19;13(7):e0201010. doi: 10.1371/journal.pone.0201010. eCollection 2018.
Results Reference
result
PubMed Identifier
29621507
Citation
Foveau P, Leroy B, Berrod JP, Conart JB. Internal Limiting Membrane Peeling in Macula-off Retinal Detachment Complicated by Grade B Proliferative Vitreoretinopathy. Am J Ophthalmol. 2018 Jul;191:1-6. doi: 10.1016/j.ajo.2018.03.037. Epub 2018 Apr 3.
Results Reference
result
PubMed Identifier
29282562
Citation
Steel DH, Joussen AM, Wong D. ILM peeling in rhegmatogenous retinal detachment; does it improve the outcome? Graefes Arch Clin Exp Ophthalmol. 2018 Feb;256(2):247-248. doi: 10.1007/s00417-017-3876-6. Epub 2017 Dec 27. No abstract available.
Results Reference
result
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Internal Limiting Membrane Peeling in Retinal Detachment Surgery
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