Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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


Condition Intervention Phase
Full Thickness Macular Hole
Procedure: Postoperative face-down posturing
Procedure: Postoperative non-posturing group
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole

Further study details as provided by Moorfields Eye Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Anatomical closure of the macula hole assessed 6 weeks following surgery by ocular coherence tomography. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visual acuity assessed 6 weeks following surgery by Snellen charts. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: January 2005
Study Completion Date: October 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Face-down posturing group
Postoperative face-down positioning for 10 days after surgery.
Procedure: Postoperative face-down posturing
Postoperative face-down posturing for 10 days after surgery.
Active Comparator: Non-posturing group
avoid a face-up position for 10 days after surgery
Procedure: Postoperative non-posturing group
avoid a face-up position only for 10 days after surgery

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226160

Locations
United Kingdom
Moorfileld's Eye Hospital
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01226160     History of Changes
Other Study ID Numbers: 06/Q0603/100/01
Study First Received: October 21, 2010
Last Updated: October 21, 2010
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Retinal Perforations
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on November 24, 2014