Internal Limiting Membrane Peeling for Large Macular Holes

NCT ID: NCT00190190

Last Updated: 2008-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2008-05-31

Brief 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. 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.

Conditions

Macular Hole

Keywords

Macular hole; internal limiting membrane; retina; surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

With Peeling of Limiting the Intern of the Retina

Group Type: EXPERIMENTAL

With Peeling of Limiting the Intern of the Retina

Intervention Type: PROCEDURE

With Peeling of Limiting the Intern of the Retina

2

Traditional Procedure Without Peeling of Limiting

Group Type: ACTIVE_COMPARATOR

Internal limiting membrane peeling

Intervention Type: PROCEDURE

Traditional Procedure Without Peeling of Limiting

Interventions

With Peeling of Limiting the Intern of the Retina

With Peeling of Limiting the Intern of the Retina

Intervention Type: PROCEDURE

Internal limiting membrane peeling

Traditional Procedure Without Peeling of Limiting

Intervention Type: PROCEDURE

Other Intervention Names

Traditional Procedure Without Peeling of Limiting

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Department Clinical Research of Developpement

Principal Investigators

Ramin TADAYONI, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service d'Ophtalmolgie de l'Hôpital Lariboisière

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 39276867 (View on PubMed)

Other Identifiers

PS040604

Identifier Type: -

Identifier Source: secondary_id

P040604

Identifier Type: -

Identifier Source: org_study_id