search
Back to results

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
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Detachment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 9, 2022
    Last Updated
    September 9, 2022
    Sponsor
    Central Hospital, Nancy, France
    search

    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

    Learn more about this trial

    Internal Limiting Membrane Peeling in Retinal Detachment Surgery

    We'll reach out to this number within 24 hrs