Internal Limiting Membrane Peeling for Large Macular Holes - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00190190

Purpose

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.

Condition	Intervention
Macular Hole	Procedure: With Peeling of Limiting the Intern of the Retina Procedure: Internal limiting membrane peeling

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence 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.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

percentage of success (anatomical closing, confirmed by OCT) at third postoperative month, in both groups [ Time Frame: at 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Gain of ETDRS visual acuity in the third postoperative month [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
Progression of cataract [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
Frequency of the complications. [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]

Enrollment:	80
Study Start Date:	January 2005
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental With Peeling of Limiting the Intern of the Retina	Procedure: With Peeling of Limiting the Intern of the Retina With Peeling of Limiting the Intern of the Retina
2: Active Comparator Traditional Procedure Without Peeling of Limiting	Procedure: Internal limiting membrane peeling Traditional Procedure Without Peeling of Limiting

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190190

Locations

France
Service d'Ophtalmolgie de l'Hôpital Lariboisière
PARIS, France, 75010

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Ramin TADAYONI, MD

Assistance Publique - Hôpitaux de Paris

More Information

Responsible Party:	Department Clinical Research of Developpement ( Yannick VACHER )
Study ID Numbers:	P040604, PS040604
Study First Received:	September 13, 2005
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00190190
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Macular hole
internal limiting membrane
retina
surgery

Study placed in the following topic categories:

Eye Diseases
Retinal Perforations
Retinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009