Protocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole|
- estimate variance and effect size order to inform power calculations for further studies. [ Time Frame: one year ] [ Designated as safety issue: No ]
- visual acuity and complications [ Time Frame: one year ] [ Designated as safety issue: No ]
- estimate recruitment rate and establish protocol/procedure [ Time Frame: one year ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
No Intervention: 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.
Experimental: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020760
|Gartnavel General Hospital|
|Glasgow, United Kingdom, G12 0YN|