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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014