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OpenTrials
Completed

NCT Number: NCT01020760

Protocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)

The purpose of this study is to determine the effect of postoperative posturing on the outcome of macular hole surgery. Current practice is divided; some individuals are advised to posture face-down for 10 days and others are advised that posturing is unnecessary. By evaluating the effect of posturing in a prospective randomised controlled trial the investigators hope to determine best practice, enabling surgeons and patients to make informed decisions regarding postoperative management.

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Key information

Conditions

Full Thickness Macular Hole Eye Diseases Retinal Diseases Retinal Perforations

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients having surgery for idiopathic full thickness macular hole
  • Able and willing to posture face-down for 10 days postoperatively
  • Agree to participate in the trial and able to give informed consent

Exclusion criteria

  • History of visual loss suggesting a duration of macular hole greater than 12 months
  • Patients unable or unwilling to posture face-down for 10 days postoperatively
  • History of trauma that may have been causative
  • Age less than 16 years (in practice idiopathic macular hole is extremely rare in patients under 30 years).
  • Previous vitrectomy surgery
  • Additional retinal breaks occurring during surgery that necessitate post-operative posturing to prevent retinal detachment.

Treatment and study plan

Face down posture

Behavioral

Patients are requested to maintain a strict face down posture for 50 minutes out of every hour for seven days after surgery.

Primary outcomes

  1. estimate variance and effect size order to inform power calculations for further studies.

    Time frame: one year

Secondary outcomes

  1. visual acuity and complications

    Time frame: one year

  2. estimate recruitment rate and establish protocol/procedure

    Time frame: one year

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Registry information

Official study title

Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 26, 2009
Registry last updated
Apr 26, 2012

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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