Clinical trial NCT00190164: Alleviated Positioning for Small Macular Holes
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Hole
Keywords: Macular hole
Vitrectomy
positioning
retina
surgery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of the successes defined by anatomical closure at third postoperative month.
timeFrame: during the 3 months
Secondary outcomes:
measure: Gain of ETDRS visual acuity in the third postoperative month.
timeFrame: during the 3 months
measure: Progression of cataract
timeFrame: during the 7 months
measure: Frequency of the complications
timeFrame: during the 7 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Service d'Ophtalmolgie de l'Hôpital Lariboisière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Ramin TADAYONI, MD
role: PRINCIPAL_INVESTIGATOR
References: