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Alleviated Positioning for Small Macular Holes

NCT00190164 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2008-07-18

No results posted yet for this study

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.

Conditions

  • Macular Hole

Interventions

PROCEDURE

Macular hole surgery with alleviated positioning

Macular hole surgery with alleviated positioning

PROCEDURE

Macular hole surgery with no alleviated positioning

Macular hole surgery with no alleviated positioning

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Ramin TADAYONI, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2007-11-30
Completion
2008-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00190164 on ClinicalTrials.gov