Alleviated Positioning for Small Macular Holes

Macular Hole Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190164
• Other study ID #: P031004
• Secondary ID: CRC03140
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: July 17, 2008
• Start date: August 2005
• Est. completion date: June 2008

Study information

• Verified date: July 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Hole
• Retinal Perforations

Intervention

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

Locations

Country	Name	City	State
France	Service d'Ophtalmolgie de l'Hôpital Lariboisière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of the successes defined by anatomical closure at third postoperative month.		during the 3 months	No
Secondary	Gain of ETDRS visual acuity in the third postoperative month.		during the 3 months	No
Secondary	Progression of cataract		during the 7 months	No
Secondary	Frequency of the complications		during the 7 months	Yes