Internal Limiting Membrane Peeling in Retinal Detachment Surgery (IMPURITY)

September 9, 2022 updated by: Central Hospital, Nancy, France

Internal Limiting Membrane Peeling in Macula-off Retinal Detachment With Grade B Proliferative Vitreoretinopathy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
The internal limiting membrane is not removed
Procedure: Control group
Vitrectomy and gas tamponade without internal limiting membrane peeling
Other: Intervention group
The internal limiting membrane of the posterior pole is removed
Procedure: Intervention group
Vitrectomy, internal limiting membrane peeling and gas tamponade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary anatomical success rate
Time Frame: 12 months after surgery
Primary retinal reattachment rate
12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcomes #1
Time Frame: 12 months after surgery
Visual acuity (Logarithm of the Minimum Angle of Resolution)
12 months after surgery
Functional outcomes #2
Time Frame: 12 months after surgery
Degree of metamorphopsia (M-CHARTS)
12 months after surgery
Anatomical outcomes #1
Time Frame: 12 months after surgery
Integrity of the photoreceptor layer on Spectral Domain Optical Coherence Tomography
12 months after surgery
Anatomical outcomes #2
Time Frame: 12 months after surgery
Incidence of epiretinal membrane
12 months after surgery
Anatomical outcomes #3
Time Frame: 12 months after surgery
Incidence of cystoid macular edema
12 months after surgery
Anatomical outcomes #4
Time Frame: 12 months after surgery
Incidence of DONFL appearance
12 months after surgery
Functional outcomes #3
Time Frame: 12 months after surgery
Retinal sensitivity on microperimetry testing
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Jean-Baptiste CONART, Prof, Brabois Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

September 1, 2026

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

September 9, 2022

First Submitted That Met QC Criteria

September 9, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 9, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A00665-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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