- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00190164
Alleviated Positioning for Small Macular Holes
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.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Paris, France, 75010
- Service d'Ophtalmolgie de l'Hôpital Lariboisière
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Macular hole surgery with alleviated positioning
|
Macular hole surgery with alleviated positioning
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No Intervention: 2
Macular hole surgery with no alleviated positioning
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Macular hole surgery with no alleviated positioning
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of the successes defined by anatomical closure at third postoperative month.
Time Frame: during the 3 months
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during the 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gain of ETDRS visual acuity in the third postoperative month.
Time Frame: during the 3 months
|
during the 3 months
|
Progression of cataract
Time Frame: during the 7 months
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during the 7 months
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Frequency of the complications
Time Frame: during the 7 months
|
during the 7 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Ramin TADAYONI, MD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P031004
- CRC03140
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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