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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01226160
First Posted: October 22, 2010
Last Update Posted: October 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Moorfields Eye Hospital NHS Foundation Trust
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226160


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

ClinicalTrials.gov Identifier: NCT01226160     History of Changes
Other Study ID Numbers: 06/Q0603/100/01
First Submitted: October 21, 2010
First Posted: October 22, 2010
Last Update Posted: October 22, 2010
Last Verified: August 2006

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases