Alleviated Positioning for Small Macular Holes

Study Overview
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Brief Summary
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Rational of the study: There are arguments to think that the closure of macular holes can be obtained without a strict positioning under certain conditions, i.e. hole size ≤ 400 µm, if the patient avoids the position laid down on the back. In order to be able to confirm these observations, it is necessary to make a randomized study with an adequate number of patients. Aim of the study: To show that the percentage of success (anatomical closure confirmed by OCT) is not lower in the group without positioning. Tested Hypothesis: The absence of strict positioning is at least as effective on the success of the surgery of small macular holes as the imposition of a strict positioning. Expected results: To show that the success rate of the surgery of the idiopathic macular holes of 400 µm or less is not decreased by the replacement of a strict positioning (face-down 22h/24) by a simple instruction of avoiding the position laid down on the back, thus avoiding the patients this painful part of the treatment and allowing a reduction in the duration of hospitalization and consequently a reduction in the cost of the treatment.

Detailed Description
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Rational of the study: There are arguments to think that the closure of macular holes can be obtained without a strict positioning under certain conditions, i.e. hole size ≤ 400 µm, if the patient avoids the position laid down on the back. In order to be able to confirm these observations, it is necessary to make a randomized study with an adequate number of patients. Main Aim of the study: To show that the percentage of success (anatomical closure confirmed by OCT) is not lower in the group without positioning. Tested Hypothesis: The absence of strict positioning is at least as effective on the success of the surgery of small macular holes as the imposition of a strict positioning. Primary outcome: Frequency of the successes defined by anatomical closing. Secondary objectives: To show the non inferiority of the technique without positioning by the following variables: - ETDRS visual acuity in the third postoperative month. - Progression of cataract - Frequency of the complications. Design of the study: Randomized multicentric study, in parallel groups, open, with individual benefit for the patient. Number of subjects and duration of the study: 68 patients, divided into two parallel groups, of more than 18 years, presenting a hole ≤ 400 µm, will be included and followed over a period of 3 months. The estimated total duration of the study is 27 months. Data analysis: In the case of this equivalence clinical trial the margin of non inferiority was fixed at 15%. The secondary criteria will consequently be analyzed. Expected results: To show that the success rate of the surgery of the idiopathic macular holes of 400 µm or less is not decreased by the replacement of a strict positioning (face-down 22h/24) by a simple instruction of avoiding the position laid down on the back, thus avoiding the patients this painful part of the treatment and allowing a reduction in the duration of hospitalization and consequently a reduction in the cost of the treatment.

Official Title
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Evaluation of the Success Rate of a Procedure Without Strict Positioning Post Surgical Versus With Positioning Face Towards the Strict Ground, at Patients Presenting a Macular Hole. Study of Non-Inferiority.

Conditions
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Macular Hole

Intervention / Treatment
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* Procedure: Macular hole surgery with alleviated positioning
* Procedure: Macular hole surgery with no alleviated positioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patient presenting an idiopathic macular hole of stage 2, 3 or 4 Opening diameter of the macular hole ≤ 400 µm Patient having been informed of the objectives and constraints of the study and having signed an informed consent Patient not presenting a per-operational complication having required a complementary gesture or a modification of the usual procedure, with the only exception of discovering a retinal tear, flat, located between 10 and 2h and having required only a treatment by cryo. Exclusion Criteria: Patient having a strong myopia of the eye operated (correction carried or optimal > 6 dioptres) Patient MONOPHTALMIA Patient presenting a non contact plan capsular CRYSTALLINE being able to leave a passage of gas towards the former segment Patient presenting an associated ocular pathology - Patient presenting a TM already operated of the eye to include (repetition or failure after a first surgery) Patient refusing to sign an assent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Macular hole surgery with alleviated positioning | Procedure: Macular hole surgery with alleviated positioning<br>* Macular hole surgery with alleviated positioning<br>|
| No Intervention: 2<br>Macular hole surgery with no alleviated positioning | Procedure: Macular hole surgery with no alleviated positioning<br>* Macular hole surgery with no alleviated positioning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of the successes defined by anatomical closure at third postoperative month. |  | during the 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gain of ETDRS visual acuity in the third postoperative month. |  | during the 3 months | 
| Progression of cataract |  | during the 7 months | 
| Frequency of the complications |  | during the 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular hole, Vitrectomy, positioning, retina, surgery