Retinal PerforationsILMTNCT02946372
Evaluation of a New Surgical Technique for Macular Hole Which Was Not Closed After a Previous Surgery
A study testing internal limiting membrane transplantation (ILMT) in people with Retinal Perforations, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Perforations
- What is being tested?
- internal limiting membrane transplantation (ILMT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged over 18,
- Patient who already received at least a macular hole surgery,
- Period of at least 4 months since last macular hole surgery,
- Patient who underwent peeling of the internal limiting membrane,
- Presents in OCT an open criteria macular hole,
- The presence of a cataract in the preoperative clinical examination is not against indication. Its removal can be integrated to the surgery,
- Patient who signed the consent form
Who cannot join
- Patient with against-indication or surgical anesthetic,
- Macular Hole "flat open" or closed,
- 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.
- Patient unaffiliated or not the beneficiary of a social security system, or equivalent health insurance,
- Pregnant or breastfeeding women,
- Absence of patient consent,
- Patient in exclusion period involved in another study,
- Patient on administrative or judicial supervision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Retinal Perforations
- Being tested
- internal limiting membrane transplantation (ILMT)
- Keywords
- retina surgery, macula, macular hole, internal limiting membrane (ILM), vitrectomy, autologous transplantation
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internal limiting membrane transplantation (ILMT)Procedure or surgery
internal limiting membrane autologous transplantation (ILMT)
| Study group | Role | What they receive |
|---|---|---|
| ILMT | Experimental | internal limiting membrane autologous transplantation (ILMT) Receives: Procedure: internal limiting membrane transplantation (ILMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of the internal limiting membrane transposed into foveal region
Measured: 8 weeks after surgery
Secondary outcomes (3)
The size and appearance of the macular hole will be assessed by optical coherence tomography (OCT)
Measured: 8 weeks after surgery
Visual acuity will be assessed by clinical examination
Measured: 8 weeks after surgery
The patient's visual comfort will be assessed using the NEI-VFQ-25 Quality of Life questionary
Measured: 8 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionFeb 2017
- Study completionJun 2017
Why it stopped: Principal investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal PerforationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick LENOBLE, MD, Principal investigator, Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946372
- Sponsor's protocol ID
- GHRMSA 872
- Other IDs
- 2016-A01431-50
- Acronym
- ILMT
- Status last verified
- Aug 2017
- First submitted
- 25 Oct 2016
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transposition of Internal Limiting Membrane in the Treatment of Macular Holes. A Descriptive Pilot Study
- ClinicalTrials.gov ID
- NCT02946372
- Acronym / sponsor ID
- ILMT / GHRMSA 872
- Conditions
- Retinal Perforations
- Keywords
- retina surgery, macula, macular hole, internal limiting membrane (ILM), vitrectomy, autologous transplantation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator left the institution
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ILMT | Experimental | Procedure: internal limiting membrane transplantation (ILMT)internal limiting membrane autologous transplantation (ILMT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient aged over 18,
- Patient who already received at least a macular hole surgery,
- Period of at least 4 months since last macular hole surgery,
- Patient who underwent peeling of the internal limiting membrane,
- Presents in OCT an open criteria macular hole,
Key exclusion criteria (8 listed)
- Patient with against-indication or surgical anesthetic,
- Macular Hole "flat open" or closed,
- 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.
- Patient unaffiliated or not the beneficiary of a social security system, or equivalent health insurance,
- Pregnant or breastfeeding women,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| internal limiting membrane transplantation (ILMT)internal limiting membrane autologous transplantation (ILMT) | Procedure or surgery | ILMT |
Primary outcome
Presence of the internal limiting membrane transposed into foveal region
Time frame: 8 weeks after surgery
3 secondary outcomes
The size and appearance of the macular hole will be assessed by optical coherence tomography (OCT)
Time frame: 8 weeks after surgery
Visual acuity will be assessed by clinical examination
Time frame: 8 weeks after surgery
The patient's visual comfort will be assessed using the NEI-VFQ-25 Quality of Life questionary
Time frame: 8 weeks after surgery
Results and safety
The study was stopped early (reason given: Principal investigator left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick LENOBLE, MD principal investigator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internal limiting membrane transplantation (ILMT) in people with Retinal Perforations, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal investigator left the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of the internal limiting membrane transposed into foveal region (time frame: 8 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.