Back to resultsPilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole
Primary Purpose
Full Thickness Macular Hole
Status
Completed
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Postoperative face-down posturing
Postoperative non-posturing group
Sponsored by
About this trial
This is an interventional treatment trial for Full Thickness Macular Hole
Eligibility Criteria
Inclusion Criteria:
- full thickness macular hole
- >16 years old
Exclusion Criteria:
- any history of previous intraocular surgery (including cataract surgery)
- history of ocular trauma
- history of visual loss greater than 1 year
Sites / Locations
- Moorfileld's Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Face-down posturing group
Non-posturing group
Arm Description
Postoperative face-down positioning for 10 days after surgery.
avoid a face-up position for 10 days after surgery
Outcomes
Primary Outcome Measures
Anatomical closure of the macula hole assessed 6 weeks following surgery by ocular coherence tomography.
Secondary Outcome Measures
Visual acuity assessed 6 weeks following surgery by Snellen charts.
Full Information
NCT ID
NCT01226160
First Posted
October 21, 2010
Last Updated
October 21, 2010
Sponsor
Moorfields Eye Hospital NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01226160
Brief Title
Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole
Official Title
Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Moorfields Eye Hospital NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a pilot randomised controlled trial (RCT) to investigate the effect of postoperative face-down positioning on the outcome of macular hole surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full Thickness Macular Hole
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Face-down posturing group
Arm Type
Experimental
Arm Description
Postoperative face-down positioning for 10 days after surgery.
Arm Title
Non-posturing group
Arm Type
Active Comparator
Arm Description
avoid a face-up position for 10 days after surgery
Intervention Type
Procedure
Intervention Name(s)
Postoperative face-down posturing
Intervention Description
Postoperative face-down posturing for 10 days after surgery.
Intervention Type
Procedure
Intervention Name(s)
Postoperative non-posturing group
Intervention Description
avoid a face-up position only for 10 days after surgery
Primary Outcome Measure Information:
Title
Anatomical closure of the macula hole assessed 6 weeks following surgery by ocular coherence tomography.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Visual acuity assessed 6 weeks following surgery by Snellen charts.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
full thickness macular hole
>16 years old
Exclusion Criteria:
any history of previous intraocular surgery (including cataract surgery)
history of ocular trauma
history of visual loss greater than 1 year
Facility Information:
Facility Name
Moorfileld's Eye Hospital
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole
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