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OpenTrials
Completed

NCT Number: NCT01974310

Postoperative Positioning After Surgery for Macular Holes

Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated by surgically removing the vitreous gel and injecting intraocular gas. Following macular hole surgery, face-down positioning is often advised with the aim of improving the likelihood of macular hole closure. The current evidence of postoperative positioning protocols is insufficient to draw firm conclusions and guide practice. The investigators wish to compare non-face-down positioning and face-down positioning after surgery for macular holes in a randomized trial.

Hypothesis: Non-face-down positioning is equivalent to face-down positioning after surgery for macular holes.

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Key information

Conditions

Macular Holes Eye Diseases Retinal Diseases Retinal Perforations

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glostrup Hospital, University of Copenhagen

Copenhagen, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Idiopathic macular hole stage II-IV
  • Informed consent
  • Duration of symptoms ≤ 24 months

Exclusion criteria

  • Previous vitreomacular surgery
  • Myopia ≥ 8 diopters
  • Ocular trauma
  • Disease affecting visual function (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)

Treatment and study plan

Vitrectomy & Intraocular gas fill

Procedure

Postoperative face-down positioning

Procedure

Primary outcomes

  1. Macular hole closure rate

    Time frame: 3 months

    Macular hole closure rate assessed by optical coherence tomography

Secondary outcomes

  1. ETDRS Visual Acuity Gain

    Time frame: 3 months

  2. Degree of postoperative head incline

    Time frame: 3 days

    Position Sensor

  3. Degree of ocular gas fill

    Time frame: 4 days

Other outcomes

  1. Frequency of the complications

    Time frame: During 3 months

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

A Randomized Clinical Trial of Face-down Protocol Versus Non-face-down Protocol After Surgery for Macular Holes.

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Nov 1, 2013
Registry last updated
Feb 11, 2016

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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