alleviated positioning for small macular holes

Conditions: Macular Hole

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.

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

Keywords: macular hole vitrectomy positioning retina surgery