NCT01020760|Completed
Protocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)
Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole
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Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole
Sponsor study identifier
interventional
30
1 country
1
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2010
Actual (reported)Study Completion
October 2010
Actual (reported)The purpose of this study is to determine the effect of postoperative posturing on the outcome of macular hole surgery. Current practice is divided; some individuals are advised to posture face-down for 10 days and others are advised that posturing is unnecessary. By evaluating the effect of posturing in a prospective randomised controlled trial the investigators hope to determine best practice, enabling surgeons and patients to make informed decisions regarding postoperative management.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
November 25, 2009
Actual (reported)November 26, 2009
Actual (reported)August 2010
Actual (reported)October 2010
Actual (reported)estimate variance and effect size order to inform power calculations for further studies.
one year
visual acuity and complications
one year
estimate recruitment rate and establish protocol/procedure
one year
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.
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.
Patients are requested to maintain a strict face down posture for 50 minutes out of every hour for seven days after surgery.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Gartnavel General Hospital
Glasgow, G12 0YN, United Kingdom
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.
30 participants (actual enrollment reported by the registry).
First Submitted
November 25, 2009
First Posted
November 26, 2009
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes
Contact the study team to confirm eligibility.
Primary Completion
August 2010
Actual (reported)Study Completion
October 2010
Actual (reported)Last Updated
April 26, 2012
Record last verified: 2012-04
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Source: ClinicalTrials.gov.
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