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Completed

NCT Number: NCT01226160

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.

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Key information

Conditions

Full Thickness Macular Hole

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Moorfileld's Eye Hospital

London, EC1V 2PD, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative face-down posturing

Procedure

Postoperative face-down posturing for 10 days after surgery.

Postoperative non-posturing group

Procedure

avoid a face-up position only for 10 days after surgery

Primary outcomes

  1. Anatomical closure of the macula hole assessed 6 weeks following surgery by ocular coherence tomography.

    Time frame: 6 weeks

Secondary outcomes

  1. Visual acuity assessed 6 weeks following surgery by Snellen charts.

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Oct 22, 2010
Registry last updated
Oct 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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