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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
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
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013