Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole

This study has been completed.
Sponsor:
Information provided by:
Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01226160
First received: October 21, 2010
Last updated: NA
Last verified: August 2006
History: No changes posted

October 21, 2010
October 21, 2010
January 2005
February 2010   (final data collection date for primary outcome measure)
Anatomical closure of the macula hole assessed 6 weeks following surgery by ocular coherence tomography. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Visual acuity assessed 6 weeks following surgery by Snellen charts. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole
Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole

This is a pilot randomised controlled trial (RCT) to investigate the effect of postoperative face-down positioning on the outcome of macular hole surgery.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Full Thickness Macular Hole
  • Procedure: Postoperative face-down posturing
    Postoperative face-down posturing for 10 days after surgery.
  • Procedure: Postoperative non-posturing group
    avoid a face-up position only for 10 days after surgery
  • Experimental: Face-down posturing group
    Postoperative face-down positioning for 10 days after surgery.
    Intervention: Procedure: Postoperative face-down posturing
  • Active Comparator: Non-posturing group
    avoid a face-up position for 10 days after surgery
    Intervention: Procedure: Postoperative non-posturing group
Not Provided

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

Inclusion Criteria:

  • full thickness macular hole
  • >16 years old

Exclusion Criteria:

  • any history of previous intraocular surgery (including cataract surgery)
  • history of ocular trauma
  • history of visual loss greater than 1 year
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01226160
06/Q0603/100/01
Yes
Not Provided
Moorfields Eye Hospital NHS Foundation Trust
Not Provided
Not Provided
Moorfields Eye Hospital NHS Foundation Trust
August 2006

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