Alleviated Positioning for Small Macular Holes

• Frequency of the successes defined by anatomical closure at third postoperative month. [ Time Frame: during the 3 months ] [ Designated as safety issue: No ]
  

• Gain of ETDRS visual acuity in the third postoperative month. [ Time Frame: during the 3 months ] [ Designated as safety issue: No ]
  
• Progression of cataract [ Time Frame: during the 7 months ] [ Designated as safety issue: No ]
  
• Frequency of the complications [ Time Frame: during the 7 months ] [ Designated as safety issue: Yes ]
  

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.