An interventional study of Face down posture in Full Thickness Macular Hole, sponsored by NHS Greater Glasgow and Clyde. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2012-04-26.
Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Treatment
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.
156 studies on the registry are indexed under Retinal Perforations; 21 are open to participants now.
This study's enrollment of 30 is below the median of 44 across 104 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →NHS Greater Glasgow and Clyde is the lead sponsor of 215 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: 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.
estimate variance and effect size order to inform power calculations for further studies.
Time frame: one year
visual acuity and complications
Time frame: one year
estimate recruitment rate and establish protocol/procedure
Time frame: one year
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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NHS Greater Glasgow and Clyde