Clinical trial NCT00190190: Internal Limiting Membrane Peeling for Large Macular Holes
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Hole
Keywords: Macular hole
internal limiting membrane
retina
surgery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: percentage of success (anatomical closing, confirmed by OCT) at third postoperative month, in both groups
timeFrame: at 3 months
Secondary outcomes:
measure: Percentage of success according to the effective success of peeling (failure, partial peeling, peeling 360°) in the peeling group of the MLI.
timeFrame: at 3 months
measure: Gain of ETDRS visual acuity in the third postoperative month
timeFrame: at 3 months
measure: Progression of cataract
timeFrame: at 3 months
measure: Frequency of the complications.
timeFrame: at 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Service d'Ophtalmolgie de l'Hôpital Lariboisière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Ramin TADAYONI, MD
role: PRINCIPAL_INVESTIGATOR
References: