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Postoperative Positioning After Surgery for Macular Holes

Primary Purpose

Macular Holes

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Vitrectomy & Intraocular gas fill
Postoperative face-down positioning
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Holes focused on measuring Macular Holes, Non face down positioning, Face down positioning

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Idiopathic macular hole stage II-IV
  • Informed consent
  • Duration of symptoms ≤ 24 months

Exclusion Criteria:

  • Previous vitreomacular surgery
  • Myopia ≥ 8 diopters
  • Ocular trauma
  • Disease affecting visual function (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)

Sites / Locations

  • Glostrup Hospital, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Face-down positioning

Non-face-down positioning

Arm Description

Patients advised face-down positioning after surgery for macular hole.

Patients advised non-face-down positioning after surgery for macular hole.

Outcomes

Primary Outcome Measures

Macular hole closure rate
Macular hole closure rate assessed by optical coherence tomography

Secondary Outcome Measures

ETDRS Visual Acuity Gain
Degree of postoperative head incline
Position Sensor
Degree of ocular gas fill

Full Information

First Posted
October 26, 2013
Last Updated
February 10, 2016
Sponsor
Glostrup University Hospital, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01974310
Brief Title
Postoperative Positioning After Surgery for Macular Holes
Official Title
A Randomized Clinical Trial of Face-down Protocol Versus Non-face-down Protocol After Surgery for Macular Holes.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated by surgically removing the vitreous gel and injecting intraocular gas. Following macular hole surgery, face-down positioning is often advised with the aim of improving the likelihood of macular hole closure. The current evidence of postoperative positioning protocols is insufficient to draw firm conclusions and guide practice. The investigators wish to compare non-face-down positioning and face-down positioning after surgery for macular holes in a randomized trial. Hypothesis: Non-face-down positioning is equivalent to face-down positioning after surgery for macular holes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes
Keywords
Macular Holes, Non face down positioning, Face down positioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Face-down positioning
Arm Type
Active Comparator
Arm Description
Patients advised face-down positioning after surgery for macular hole.
Arm Title
Non-face-down positioning
Arm Type
Experimental
Arm Description
Patients advised non-face-down positioning after surgery for macular hole.
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy & Intraocular gas fill
Intervention Type
Procedure
Intervention Name(s)
Postoperative face-down positioning
Primary Outcome Measure Information:
Title
Macular hole closure rate
Description
Macular hole closure rate assessed by optical coherence tomography
Time Frame
3 months
Secondary Outcome Measure Information:
Title
ETDRS Visual Acuity Gain
Time Frame
3 months
Title
Degree of postoperative head incline
Description
Position Sensor
Time Frame
3 days
Title
Degree of ocular gas fill
Time Frame
4 days
Other Pre-specified Outcome Measures:
Title
Frequency of the complications
Time Frame
During 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic macular hole stage II-IV Informed consent Duration of symptoms ≤ 24 months Exclusion Criteria: Previous vitreomacular surgery Myopia ≥ 8 diopters Ocular trauma Disease affecting visual function (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten la Cour, Professor
Organizational Affiliation
Glostrup University Hospital, Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
Glostrup Hospital, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

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Postoperative Positioning After Surgery for Macular Holes

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