Protocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Yorston, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT01020760
First received: November 25, 2009
Last updated: April 25, 2012
Last verified: April 2012

November 25, 2009
April 25, 2012
September 2008
August 2010   (final data collection date for primary outcome measure)
estimate variance and effect size order to inform power calculations for further studies. [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01020760 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Protocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)
Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Full Thickness Macular Hole
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.
  • 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.
    Intervention: Behavioral: Face down posture
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. Erratum in: Eye (Lond). 2012 Feb;26(2):341.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients having surgery for idiopathic full thickness macular hole
  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:

  1. History of visual loss suggesting a duration of macular hole greater than 12 months
  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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01020760
Version 1
No
David Yorston, NHS Greater Glasgow and Clyde
NHS Greater Glasgow and Clyde
Not Provided
Not Provided
NHS Greater Glasgow and Clyde
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP