Protocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)
NCT ID: NCT01020760
Last Updated: 2012-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2008-09-30
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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No posture
Patients will undergo routine phacoemulsification, pars plana vitrectomy, ILM peel and gas fluid exchange with 14% C3F8. They will be advised to avoid supine posturing for seven days after surgery, but will not be advised to posture in the face down or prone position.
No interventions assigned to this group
Face down posture
Patients will undergo routine phacoemulsification, pars plana vitrectomy, ILM peel and gas fluid exchange with 14% C3F8. They will be advised to posture in the face down or prone position for 50 minutes per hour for seven days.
Face down posture
Patients are requested to maintain a strict face down posture for 50 minutes out of every hour for seven days after surgery.
Interventions
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Face down posture
Patients are requested to maintain a strict face down posture for 50 minutes out of every hour for seven days after surgery.
Eligibility Criteria
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Inclusion Criteria
2. Able and willing to posture face-down for 10 days postoperatively
3. Agree to participate in the trial and able to give informed consent
Exclusion Criteria
2. Patients unable or unwilling to posture face-down for 10 days postoperatively
3. History of trauma that may have been causative
4. Age less than 16 years (in practice idiopathic macular hole is extremely rare in patients under 30 years).
5. Previous vitrectomy surgery
6. Additional retinal breaks occurring during surgery that necessitate post-operative posturing to prevent retinal detachment.
16 Years
ALL
No
Sponsors
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NHS Greater Glasgow and Clyde
OTHER
Responsible Party
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David Yorston
Consultant Ophthalmologist
Locations
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Gartnavel General Hospital
Glasgow, , United Kingdom
Countries
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References
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Yorston D, Siddiqui MA, Awan MA, Walker S, Bunce C, Bainbridge JW. Pilot randomised controlled trial of face-down posturing following phacovitrectomy for macular hole. Eye (Lond). 2012 Feb;26(2):267-71. doi: 10.1038/eye.2011.220. Epub 2011 Sep 23.
Other Identifiers
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Version 1
Identifier Type: -
Identifier Source: org_study_id
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