Alleviated Positioning for Small Macular Holes

Not Applicable

Completed

• Conditions: Macular Hole

• 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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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