Alleviated Positioning for Small Macular Holes

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190164
First received: September 12, 2005
Last updated: July 17, 2008
Last verified: July 2007
  Purpose

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
Macular Hole
Procedure: Macular hole surgery with alleviated positioning
Procedure: Macular hole surgery with no alleviated positioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Frequency of the successes defined by anatomical closure at third postoperative month. [ Time Frame: during the 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gain of ETDRS visual acuity in the third postoperative month. [ Time Frame: during the 3 months ] [ Designated as safety issue: No ]
  • Progression of cataract [ Time Frame: during the 7 months ] [ Designated as safety issue: No ]
  • Frequency of the complications [ Time Frame: during the 7 months ] [ Designated as safety issue: Yes ]

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
Experimental: 1
Macular hole surgery with alleviated positioning
Procedure: Macular hole surgery with alleviated positioning
Macular hole surgery with alleviated positioning
Other Name: 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
Other Name: Macular hole surgery with no alleviated positioning

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190164

Locations
France
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
  More Information

No publications provided

Responsible Party: Christophe AUCAN, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00190164     History of Changes
Other Study ID Numbers: P031004, CRC03140
Study First Received: September 12, 2005
Last Updated: July 17, 2008
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Macular hole
Vitrectomy
positioning
retina
surgery

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014