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Internal Limiting Membrane Peeling for Large Macular Holes

Primary Purpose

Macular Hole

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
With Peeling of Limiting the Intern of the Retina
Internal limiting membrane peeling
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Hole focused on measuring Macular hole, internal limiting membrane, retina, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service d'Ophtalmolgie de l'Hôpital Lariboisière

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

With Peeling of Limiting the Intern of the Retina

Traditional Procedure Without Peeling of Limiting

Outcomes

Primary Outcome Measures

percentage of success (anatomical closing, confirmed by OCT) at third postoperative month, in both groups

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.
Gain of ETDRS visual acuity in the third postoperative month
Progression of cataract
Frequency of the complications.

Full Information

First Posted
September 13, 2005
Last Updated
July 16, 2008
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00190190
Brief Title
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

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Hole
Keywords
Macular hole, internal limiting membrane, retina, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
With Peeling of Limiting the Intern of the Retina
Arm Title
2
Arm Type
Active Comparator
Arm Description
Traditional Procedure Without Peeling of Limiting
Intervention Type
Procedure
Intervention Name(s)
With Peeling of Limiting the Intern of the Retina
Intervention Description
With Peeling of Limiting the Intern of the Retina
Intervention Type
Procedure
Intervention Name(s)
Internal limiting membrane peeling
Other Intervention Name(s)
Traditional Procedure Without Peeling of Limiting
Intervention Description
Traditional Procedure Without Peeling of Limiting
Primary Outcome Measure Information:
Title
percentage of success (anatomical closing, confirmed by OCT) at third postoperative month, in both groups
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
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
Title
Gain of ETDRS visual acuity in the third postoperative month
Time Frame
at 3 months
Title
Progression of cataract
Time Frame
at 3 months
Title
Frequency of the complications.
Time Frame
at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramin TADAYONI, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Ophtalmolgie de l'Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France

12. IPD Sharing Statement

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Internal Limiting Membrane Peeling for Large Macular Holes

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