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OpenTrials
Completed

NCT Number: NCT02028481

Air Tamponade in Macular Holes < 400 μm

Macular hole is a hole formation which takes place in the center of the retina. Such a hole needs surgical steps in order to close. Closure of the macular hole will lead to a substantially improvement of vision in most cases. Following macular hole surgery a tamponade of intraocular gas is normally injected in order to keep the macula dry for the postoperative period. Postoperative face down position for a week was earlier standard. Several authors report of good closure rates with both air tamponade or lack of face down positioning. In this study standard pars plana vitrectomy with peeling of the internal limiting membrane (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down positioning will not be used. Only macular holes less than 400 μm will be included.

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Key information

Conditions

Macular Holes Eye Diseases Retinal Diseases Retinal Perforations

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stavanger University Hospital, Department of Ophthalmology

Stavanger, 4016, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary macular hole less than 400 μm in diameter
  • Duration of symptoms less than 36 months
  • Informed consent

Exclusion criteria

  • Previous vitreomacular surgery
  • Myopia more than 6 diopters
  • Ocular trauma
  • Disease affecting visual function

Treatment and study plan

Postoperative air tamponade

Procedure

Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.

Primary outcomes

  1. Closure rate of macular hole

    Time frame: 1 month after enrollment

Other outcomes

  1. Visual gain after 6 months of follow up

    Time frame: 6 months after enrollment

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • Haukeland University Hospital

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jan 7, 2014
Registry last updated
Oct 27, 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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