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TerminatedNCT02946372ILMTUpdated Nov 20, 2025

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

An interventional study of internal limiting membrane transplantation (ILMT) in Retinal Perforations, sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.

Sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace · Not applicable, Interventional, and Treatment

Why this study was terminated
Principal investigator left the institution
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Retinal Perforations

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Keywords

  • retina surgery
  • macula
  • macular hole
  • internal limiting membrane (ILM)
  • vitrectomy
  • autologous transplantation
03

In context

Retinal Perforations

139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.

This study's enrollment of 16 is below the median of 50 across 94 interventional studies indexed under Retinal Perforations.

Browse Retinal Perforations studies →

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    ILMT

    internal limiting membrane autologous transplantation (ILMT)

    Procedure: internal limiting membrane transplantation (ILMT)

Interventions

  • Procedureinternal limiting membrane transplantation (ILMT)

    internal limiting membrane autologous transplantation (ILMT)

06

What researchers measure

Primary outcomes

  1. Presence of the internal limiting membrane transposed into foveal region

    Time frame: 8 weeks after surgery

Secondary outcomes

  1. The size and appearance of the macular hole will be assessed by optical coherence tomography (OCT)

    Time frame: 8 weeks after surgery

  2. Visual acuity will be assessed by clinical examination

    Time frame: 8 weeks after surgery

  3. The patient's visual comfort will be assessed using the NEI-VFQ-25 Quality of Life questionary

    Time frame: 8 weeks after surgery

07

Study locations

1 site
  • GHRMSA
    Mulhouse, 68100, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02946372
Lead sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Responsible party
Sponsor
First posted
Oct 27, 2016
Start date
Nov 2016
Primary completion
Feb 2017
Completion
Jun 2017
Last update
Nov 20, 2025

Study contacts

Patrick LENOBLE, MD
principal investigator · Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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