Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2005-08-31
2008-06-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Macular hole surgery with alleviated positioning
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
Macular hole surgery with no alleviated positioning
Interventions
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Macular hole surgery with alleviated positioning
Macular hole surgery with alleviated positioning
Macular hole surgery with no alleviated positioning
Macular hole surgery with no alleviated positioning
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Department Clinical Research of Developpement
Principal Investigators
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Ramin TADAYONI, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Service d'Ophtalmolgie de l'Hôpital Lariboisière
Paris, , France
Countries
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Other Identifiers
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CRC03140
Identifier Type: -
Identifier Source: secondary_id
P031004
Identifier Type: -
Identifier Source: org_study_id