Macular HoleNCT00190190
Internal Limiting Membrane Peeling for Large Macular Holes
A study testing With Peeling of Limiting the Intern of the Retina and Internal limiting membrane peeling in people with Macular Hole, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Rational of the study: for macular holes larger than 400 µm the rate of failure is of more than 20%. It is for these eyes that it is necessary to show the benefit of internal limiting membrane (ILM) peeling in term of vision and success rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Hole
- What is being tested?
- With Peeling of Limiting the Intern of the Retina and Internal limiting membrane peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2005to May 2008
- 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
- Age equal to or higher than 18 years
- Patient presenting a TM idiopathic of stage 2, 3 or 4
- Macular hole > 400 µm in diameter
- Patient having been informed of the objectives and constraints of the study and having signed an informed consent
Who cannot join
- Patient age < 18 years.
- Patient having a strong myopia of the operated eye: correction carried or optimal >6 dioptres
- Patient MONOPHTHALMIA.
- Patient pseudophakia presenting an "insufficient" plan capsular CRYTALLINE.
- Patient presenting a cataract making impossible a good visualization of the bottom of eye.
- Patient presenting an important opacification capsular.
- Patient presenting an associated ocular pathology being able to interfere with the operation.
- Patient presenting a TM already operated of the eye to include
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Success Rate of a Procedure With Peeling of Limiting the Intern of the Retina Versus a Traditional Procedure Without Peeling of Limiting, at Patients Presenting a Macular Hole.
Rational of the study: for macular holes larger than 400 µm the rate of failure is of more than 20%. It is for these eyes that it is necessary to show the benefit of internal limiting membrane (ILM) peeling in term of vision and success rate. In order to test the benefit of this gesture, it is necessary to make a randomized study.
Primary objective: To show that the percentage of success (anatomical closing, confirmed by OCT) at third postoperative month is higher in the ILM peeling group.
Read more
Design of the study: Randomized multicentric study, in parallel groups, with individual benefit for the patient.
Tested Hypothesis: The success rate of the surgery of idiopathic macular holes larger than 400 µm is increased by the peeling of the MLI.
Awaited results: To show that the success rate of the surgery of idiopathic macular holes larger than 400 µm is improved by ILM peeling. This category could then have a success rate similar to the small holes. If this difference is not proven, it will remain no justification to continue this procedure which represents little risk but which is not either without consequence.
Read the detailed description
Rational of the study: for macular holes larger than 400 µm the rate of failure is of more than 20%. It is for these eyes that it is necessary to show the benefit of internal limiting membrane (ILM) peeling in term of vision and success rate. In order to test the benefit of this gesture, it is necessary to make a randomized study.
Primary objective: To show that the percentage of success (anatomical closing, confirmed by OCT) at three postoperative months is higher in the ILM peeling group.
Design of the study: Randomized multicentric study, in parallel groups, with individual benefit for the patient.
Tested Hypothesis: The success rate of the surgery of idiopathic macular holes larger than 400 µm is increased by the peeling of the MLI.
Secondary objectives: - Percentage of success according to the effective success of peeling (failure, partial peeling, peeling 360°) in the peeling group of the MLI. - Gain of ETDRS visual acuity in the third postoperative month.- Progression of cataract - Frequency of the complications.
Number of subjects and duration of the study: 80 patients older than 18 yo , presenting a macular hole > 400 µm, divided into two parallel groups will be included and followed up 3 months. The estimated total duration of the study is 27 months.
Statistical analysis: The percentages of success in the 2 groups will be compared by a Chi ² or Fisher exact test. The test Q of COCHRAN will be used to take into account the ordered character of the categories.
Intermediate Analysis: An intermediate analysis is envisaged. The procedure of adjustment of the risk of Lan and DeMets will be used.
Awaited results: To show that the success rate of the surgery of idiopathic macular holes larger than 400 µm is improved by ILM peeling. This category could then have a success rate similar to the small holes. If this difference is not proven, it will remain no justification to continue this procedure which represents little risk but which is not either without consequence.
- Conditions
- Macular Hole
- Being tested
- With Peeling of Limiting the Intern of the Retina, Internal limiting membrane peeling
- Keywords
- Macular hole, internal limiting membrane, retina, surgery
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With Peeling of Limiting the Intern of the RetinaProcedure or surgery
With Peeling of Limiting the Intern of the Retina
Internal limiting membrane peelingProcedure or surgery
Also called Traditional Procedure Without Peeling of Limiting
Traditional Procedure Without Peeling of Limiting
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | With Peeling of Limiting the Intern of the Retina Receives: Procedure: With Peeling of Limiting the Intern of the Retina |
| 2 | Active comparator | Traditional Procedure Without Peeling of Limiting Receives: Procedure: Internal limiting membrane peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of success (anatomical closing, confirmed by OCT) at third postoperative month, in both groups
Measured: at 3 months
Secondary outcomes (4)
Percentage of success according to the effective success of peeling (failure, partial peeling, peeling 360°) in the peeling group of the MLI.
Measured: at 3 months
Gain of ETDRS visual acuity in the third postoperative month
Measured: at 3 months
Progression of cataract
Measured: at 3 months
Frequency of the complications.
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular HoleStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Ramin TADAYONI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190190
- Sponsor's protocol ID
- P040604
- Other IDs
- PS040604
- Status last verified
- Jul 2007
- First submitted
- 13 Sep 2005
- Last updated
- 18 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Garcin T, Gaudric A, Sikorav A, Tadayoni R, Couturier A. Internal Limiting Membrane Peeling for Large Macular Holes Induces Only Structural Remodeling without Functional Impairment Over 12 Years. Ophthalmol Retina. 2025 Mar;9(3):253-262. doi: 10.1016/j.oret.2024.09.005. Epub 2024 Sep 12.
PubMed 39276867
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Success Rate of a Procedure With Peeling of Limiting the Intern of the Retina Versus a Traditional Procedure Without Peeling of Limiting, at Patients Presenting a Macular Hole.
- ClinicalTrials.gov ID
- NCT00190190
- Acronym / sponsor ID
- P040604
- Conditions
- Macular Hole
- Keywords
- Macular hole, internal limiting membrane, retina, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 19 Sep 2005 (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.
Rational of the study: for macular holes larger than 400 µm the rate of failure is of more than 20%. It is for these eyes that it is necessary to show the benefit of internal limiting membrane (ILM) peeling in term of vision and success rate. In order to test the benefit of this gesture, it is necessary to make a randomized study.
Primary objective: To show that the percentage of success (anatomical closing, confirmed by OCT) at third postoperative month is higher in the ILM peeling group.
Design of the study: Randomized multicentric study, in parallel groups, with individual benefit for the patient.
Tested Hypothesis: The success rate of the surgery of idiopathic macular holes larger than 400 µm is increased by the peeling of the MLI.
Awaited results: To show that the success rate of the surgery of idiopathic macular holes larger than 400 µm is improved by ILM peeling. This category could then have a success rate similar to the small holes. If this difference is not proven, it will remain no justification to continue this procedure which represents little risk but which is not either without consequence.
Detailed description
Rational of the study: for macular holes larger than 400 µm the rate of failure is of more than 20%. It is for these eyes that it is necessary to show the benefit of internal limiting membrane (ILM) peeling in term of vision and success rate. In order to test the benefit of this gesture, it is necessary to make a randomized study.
Primary objective: To show that the percentage of success (anatomical closing, confirmed by OCT) at three postoperative months is higher in the ILM peeling group.
Design of the study: Randomized multicentric study, in parallel groups, with individual benefit for the patient.
Tested Hypothesis: The success rate of the surgery of idiopathic macular holes larger than 400 µm is increased by the peeling of the MLI.
Secondary objectives: - Percentage of success according to the effective success of peeling (failure, partial peeling, peeling 360°) in the peeling group of the MLI. - Gain of ETDRS visual acuity in the third postoperative month.- Progression of cataract - Frequency of the complications.
Number of subjects and duration of the study: 80 patients older than 18 yo , presenting a macular hole > 400 µm, divided into two parallel groups will be included and followed up 3 months. The estimated total duration of the study is 27 months.
Statistical analysis: The percentages of success in the 2 groups will be compared by a Chi ² or Fisher exact test. The test Q of COCHRAN will be used to take into account the ordered character of the categories.
Intermediate Analysis: An intermediate analysis is envisaged. The procedure of adjustment of the risk of Lan and DeMets will be used.
Awaited results: To show that the success rate of the surgery of idiopathic macular holes larger than 400 µm is improved by ILM peeling. This category could then have a success rate similar to the small holes. If this difference is not proven, it will remain no justification to continue this procedure which represents little risk but which is not either without consequence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: With Peeling of Limiting the Intern of the RetinaWith Peeling of Limiting the Intern of the Retina |
| 2 | Active comparator | Procedure: Internal limiting membrane peelingTraditional Procedure Without Peeling of Limiting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age equal to or higher than 18 years
- Patient presenting a TM idiopathic of stage 2, 3 or 4
- Macular hole > 400 µm in diameter
- Patient having been informed of the objectives and constraints of the study and having signed an informed consent
Key exclusion criteria (8 listed)
- Patient age < 18 years.
- Patient having a strong myopia of the operated eye: correction carried or optimal >6 dioptres
- Patient MONOPHTHALMIA.
- Patient pseudophakia presenting an "insufficient" plan capsular CRYTALLINE.
- Patient presenting a cataract making impossible a good visualization of the bottom of eye.
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 |
|---|---|---|
| With Peeling of Limiting the Intern of the RetinaWith Peeling of Limiting the Intern of the Retina | Procedure or surgery | 1 |
| Internal limiting membrane peelingAlso: Traditional Procedure Without Peeling of LimitingTraditional Procedure Without Peeling of Limiting | Procedure or surgery | 2 |
Primary outcome
percentage of success (anatomical closing, confirmed by OCT) at third postoperative month, in both groups
Time frame: at 3 months
4 secondary outcomes
Percentage of success according to the effective success of peeling (failure, partial peeling, peeling 360°) in the peeling group of the MLI.
Time frame: at 3 months
Gain of ETDRS visual acuity in the third postoperative month
Time frame: at 3 months
Progression of cataract
Time frame: at 3 months
Frequency of the complications.
Time frame: at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2008.
- Derived from this study: PubMed 39276867Garcin T, Gaudric A, Sikorav A, Tadayoni R, Couturier A. Internal Limiting Membrane Peeling for Large Macular Holes Induces Only Structural Remodeling without Functional Impairment Over 12 Years. Ophthalmol Retina. 2025 Mar;9(3):253-262. doi: 10.1016/j.oret.2024.09.005. Epub 2024 Sep 12.
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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.
Ramin TADAYONI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With Peeling of Limiting the Intern of the Retina and Internal limiting membrane peeling in people with Macular Hole, run by Assistance Publique - Hôpitaux de Paris 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 4 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: finished, as of the sponsor's last update on 18 Jul 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
percentage of success (anatomical closing, confirmed by OCT) at third postoperative month, in both groups (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00190190, which also lists 1 linked publication.
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 18 Jul 2008.