Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190164
Status:
COMPLETED
Last Update Posted:
2008-07-18
First Post:
2005-09-12
Brief Title:
Alleviated Positioning for Small Macular Holes
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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 22h24 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
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 22h24 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
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 ie 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 22h24 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
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 22h24 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CRC03140 | None | None | None |