Alleviated Positioning for Small Macular Holes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Macular hole surgery with alleviated positioning |
Procedure: Macular hole surgery with alleviated positioning
Macular hole surgery with alleviated positioning
|
| No Intervention: 2 Macular hole surgery with no alleviated positioning |
Procedure: Macular hole surgery with no alleviated positioning
Macular hole surgery with no alleviated positioning
|
Outcome Measures
Primary Outcome Measures
- Frequency of the successes defined by anatomical closure at third postoperative month. [during the 3 months]
Secondary Outcome Measures
- Gain of ETDRS visual acuity in the third postoperative month. [during the 3 months]
- Progression of cataract [during the 7 months]
- Frequency of the complications [during the 7 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 years
-
Patient presenting an idiopathic macular hole of stage 2, 3 or 4
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Opening diameter of the macular hole ≤ 400 µm
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Patient having been informed of the objectives and constraints of the study and having signed an informed consent
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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:
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Patient having a strong myopia of the eye operated (correction carried or optimal > 6 dioptres)
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Patient MONOPHTALMIA
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Patient presenting a non contact plan capsular CRYSTALLINE being able to leave a passage of gas towards the former segment
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Patient presenting an associated ocular pathology -
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Patient presenting a TM already operated of the eye to include (repetition or failure after a first surgery)
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Patient refusing to sign an assent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service d'Ophtalmolgie de l'Hôpital Lariboisière | Paris | France | 75010 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Ramin TADAYONI, MD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P031004
- CRC03140