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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00190164 |
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.
Condition | Intervention |
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Macular Hole |
Procedure: Macular hole surgery with alleviated positioning Procedure: Macular hole surgery with no alleviated positioning |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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. |
Enrollment: | 69 |
Study Start Date: | August 2005 |
Study Completion Date: | June 2008 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Macular hole surgery with alleviated positioning
|
Procedure: Macular hole surgery with alleviated positioning
Macular hole surgery with alleviated positioning
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2: No Intervention
Macular hole surgery with no alleviated positioning
|
Procedure: Macular hole surgery with no alleviated positioning
Macular hole surgery with no alleviated positioning
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Service d'Ophtalmolgie de l'Hôpital Lariboisière | |
Paris, France, 75010 |
Principal Investigator: | Ramin TADAYONI, MD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Research of Developpement ( Christophe AUCAN ) |
Study ID Numbers: | P031004, CRC03140 |
Study First Received: | September 12, 2005 |
Last Updated: | July 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00190164 |
Health Authority: | France: Ministry of Health |
Macular hole Vitrectomy positioning retina surgery |
Facies Eye Diseases Retinal Perforations Retinal Diseases |