Evaluation of a New Surgical Technique for Macular Hole Which Was Not Closed After a Previous Surgery (ILMT)

Transposition of Internal Limiting Membrane in the Treatment of Macular Holes. A Descriptive Pilot Study

Macular hole is an infrequent retinal pathology (2 to 4/1000) which most often affects people aged over 60, and twice common in women than men.

The vast majority of cases are idiopathic. Without treatment, the macular hole evolves through a series of stages until the extension of the diameter (up to 500 microns and higher values). With a fully developed macular hole, patients complain of metamorphopsia and decreased visual acuity.

This pathology has clearly benefited from advances in microsurgery and better understanding of its pathophysiology. Macular hole treatment has evolved to include small-gauge pars plana vitrectomy with or without internal limiting membrane (ILM) peeling and placement of intraocular gas tamponade.

The postoperative closure rate is close to 80%, but strongly depends on the initial characteristics of the hole, its diameter remaining the main prognostic factor. Thus for macular holes <400 microns, the closure rate is close to 92% dropping to 56% for macular holes above 400 microns. In case of surgical failure, one or more reoperations can be proposed, but with a lower closure rate.

The quest for a surgical technique presenting a greater success rate is a common goal to all retinologists.

Here the investigators propose a new surgical technique, derived from the FLAP method, and consisting of an inner limiting membrane transposition.

The objective of this study is to evaluate the feasibility of a new surgical technique for the treatment of macular holes already operated but without macular hole closure, allowing these patients a new therapeutic alternative. The success of this technique will be confirmed by detecting postoperatively the presence of the transposed internal limiting membrane into the foveal region.

Study Overview

• Status: Completed
• Conditions: Retinal Perforations
• Intervention / Treatment: Procedure: internal limiting membrane transplantation (ILMT)

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Mulhouse, France, 68100
    • GHRMSA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient aged over 18,
2. Patient who already received at least a macular hole surgery,
3. Period of at least 4 months since last macular hole surgery,
4. Patient who underwent peeling of the internal limiting membrane,
5. Presents in OCT an open criteria macular hole,
6. The presence of a cataract in the preoperative clinical examination is not against indication. Its removal can be integrated to the surgery,
7. Patient who signed the consent form

Exclusion Criteria:

1. Patient with against-indication or surgical anesthetic,
2. Macular Hole "flat open" or closed,
3. No progressive macular pathology other than the presence of a macular hole (retinal detachment, Macular degeneration related to age) Idiopathic and secondary macular holes are eligible if they have already been operated with the prior internal limiting membrane coat.
4. Patient unaffiliated or not the beneficiary of a social security system, or equivalent health insurance,
5. Pregnant or breastfeeding women,
6. Absence of patient consent,
7. Patient in exclusion period involved in another study,
8. Patient on administrative or judicial supervision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ILMT; internal limiting membrane autologous transplantation (ILMT)	Procedure: internal limiting membrane transplantation (ILMT); internal limiting membrane autologous transplantation (ILMT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of the internal limiting membrane transposed into foveal region	8 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
The size and appearance of the macular hole will be assessed by optical coherence tomography (OCT)	8 weeks after surgery
Visual acuity will be assessed by clinical examination	8 weeks after surgery
The patient's visual comfort will be assessed using the NEI-VFQ-25 Quality of Life questionary	8 weeks after surgery

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Investigators: Principal Investigator: Patrick LENOBLE, MD, Groupe hospitalier de la région de Mulhouse et Sud Alsace

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (Estimate): October 27, 2016

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: vitrectomy; macular hole; macula; autologous transplantation; retina surgery; internal limiting membrane (ILM)
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: GHR n°872; 2016-A01431-50 (Registry Identifier: ID/RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO