Air Tamponade in Macular Holes < 400 μm
Primary Purpose
Macular Holes
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Postoperative air tamponade
Sponsored by
About this trial
This is an interventional treatment trial for Macular Holes focused on measuring Macular hole, Vitreoretinal surgery, Macular surgery, Air tamponade
Eligibility Criteria
Inclusion Criteria:
- Primary macular hole less than 400 μm in diameter
- Duration of symptoms less than 36 months
- Informed consent
Exclusion Criteria:
- Previous vitreomacular surgery
- Myopia more than 6 diopters
- Ocular trauma
- Disease affecting visual function
Sites / Locations
- Stavanger University Hospital, Department of Ophthalmology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Postoperative air tamponade
Arm Description
Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.
Outcomes
Primary Outcome Measures
Closure rate of macular hole
Secondary Outcome Measures
Full Information
NCT ID
NCT02028481
First Posted
January 3, 2014
Last Updated
October 26, 2016
Sponsor
Helse Stavanger HF
Collaborators
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02028481
Brief Title
Air Tamponade in Macular Holes < 400 μm
Official Title
Air Tamponade in Macular Holes < 400 μm
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
Collaborators
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Macular hole is a hole formation which takes place in the center of the retina. Such a hole needs surgical steps in order to close. Closure of the macular hole will lead to a substantially improvement of vision in most cases. Following macular hole surgery a tamponade of intraocular gas is normally injected in order to keep the macula dry for the postoperative period. Postoperative face down position for a week was earlier standard. Several authors report of good closure rates with both air tamponade or lack of face down positioning. In this study standard pars plana vitrectomy with peeling of the internal limiting membrane (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down positioning will not be used. Only macular holes less than 400 μm will be included.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes
Keywords
Macular hole, Vitreoretinal surgery, Macular surgery, Air tamponade
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Postoperative air tamponade
Arm Type
Experimental
Arm Description
Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.
Intervention Type
Procedure
Intervention Name(s)
Postoperative air tamponade
Intervention Description
Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.
Primary Outcome Measure Information:
Title
Closure rate of macular hole
Time Frame
1 month after enrollment
Other Pre-specified Outcome Measures:
Title
Visual gain after 6 months of follow up
Time Frame
6 months after enrollment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary macular hole less than 400 μm in diameter
Duration of symptoms less than 36 months
Informed consent
Exclusion Criteria:
Previous vitreomacular surgery
Myopia more than 6 diopters
Ocular trauma
Disease affecting visual function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vegard Forsaa, MD
Organizational Affiliation
Helse Stavanger HF
Official's Role
Study Director
Facility Information:
Facility Name
Stavanger University Hospital, Department of Ophthalmology
City
Stavanger
ZIP/Postal Code
4016
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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Air Tamponade in Macular Holes < 400 μm
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