Alleviated Positioning for Small Macular Holes
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.
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
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Macular Hole
Intervention
Macular hole surgery with alleviated positioning, Macular hole surgery with no alleviated positioning
Location
Service d'Ophtalmolgie de l'Hôpital Lariboisière
Paris
France
75010
Status
Completed
Source
Assistance Publique - Hôpitaux de Paris
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00190164
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Macular Edema
Fluid accumulation in the outer layer of the MACULA LUTEA that results from intraocular or systemic insults. It may develop in a diffuse pattern where the macula appears thickened or it may acquire the characteristic petaloid appearance referred to as cystoid macular edema. Although macular edema may be associated with various underlying conditions, it is most commonly seen following intraocular surgery, venous occlusive disease, DIABETIC RETINOPATHY, and posterior segment inflammatory disease. (From Survey of Ophthalmology 2004; 49(5) 470-90)
Geographic Atrophy
A form of MACULAR DEGENERATION also known as dry macular degeneration marked by occurrence of a well-defined progressive lesion or atrophy in the central part of the RETINA called the MACULA LUTEA. It is distinguishable from WET MACULAR DEGENERATION in that the latter involves neovascular exudates.
Vitreoretinal Surgery
Specialized ophthalmic technique used in the surgical repair and or treatment of disorders that include retinal tears or detachment; MACULAR HOLES; hereditary retinal disease; AIDS-related retinal infections; ocular tumors; MACULAR DEGENERATION; DIABETIC RETINOPATHY; and UVEITIS.
Esophageal Perforation
An opening or hole in the ESOPHAGUS that is caused by TRAUMA, injury, or pathological process.
Uterine Perforation
A hole or break through the wall of the UTERUS, usually made by the placement of an instrument or INTRAUTERINE DEVICES.
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PubMed Articles
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