Alleviated Positioning for Small Macular Holes

Not Applicable

Completed

• Conditions: Macular Hole
• Interventions: Procedure: Macular hole surgery with alleviated positioning; Procedure: Macular hole surgery with no alleviated positioning

• Registration Number: NCT00190164
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Status Verified: 2007-07
• Primary Completion: 2007-11
• Study Completion: 2008-06
• Last Update Submitted: 2008-07-17
• Last Update Posted: 2008-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Macular hole surgery with alleviated positioning	Macular hole surgery with alleviated positioning
2	Macular hole surgery with no alleviated positioning	Macular hole surgery with no alleviated positioning

Primary Outcome Measures

Name	Time	Method
Frequency of the successes defined by anatomical closure at third postoperative month.	during the 3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service d'Ophtalmolgie de l'Hôpital Lariboisière; 🇫🇷 Paris, France