Internal Limiting Membrane Peeling in Retinal Detachment Surgery

NCT05538156 | Not Yet Recruiting

• 1 other identifier: 2022-A00665-38
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Retinal Detachment; Proliferative Vitreoretinopathy

Outcome Measures

Primary Outcomes (1)

• Primary anatomical success rate

  Primary retinal reattachment rate

  12 months after surgery

Secondary Outcomes (7)

• Functional outcomes #1

  12 months after surgery

• Functional outcomes #2

  12 months after surgery

• Anatomical outcomes #1

  12 months after surgery

• Anatomical outcomes #2

  12 months after surgery

• Anatomical outcomes #3

  12 months after surgery

Study Arms (2)

Control group

OTHER

The internal limiting membrane is not removed

Procedure: Control group

Intervention group

OTHER

The internal limiting membrane of the posterior pole is removed

Procedure: Intervention group

Interventions

Control group PROCEDURE

Vitrectomy and gas tamponade without internal limiting membrane peeling

Control group

Intervention group PROCEDURE

Vitrectomy, internal limiting membrane peeling and gas tamponade

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years old
• With macula-off retinal detachment complicated by grade B proliferative vitreoretinopathy

You may not qualify if:

• 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)

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Related Publications (6)

• 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.

  PMID: 31126280 RESULT

• 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.

  PMID: 7488586 RESULT

• 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.

  PMID: 29299741 RESULT

• 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.

  PMID: 30024983 RESULT

• 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.

  PMID: 29621507 RESULT

• 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.

  PMID: 29282562 RESULT

MeSH Terms

Conditions

Retinal Detachment; Vitreoretinopathy, Proliferative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jean-Baptiste CONART, Prof

  Brabois Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Baptiste CONART, Prof

CONTACT

+33383155101; jbconart@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 13, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share