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OpenTrials
Completed

NCT Number: NCT02011165

An Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

The macular hole formation takes place in the centre of the retina. A closure of the macular hole is believed to take place if the central retinal area is kept dry in the postoperative period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the supine position in the first postoperative days. The investigators use the "tennis ball technique" where a tennis ball is fastened in the back of the night shirt in order to help patients compliance in avoiding the supine sleeping position. The investigators have developed a positioning measuring device which can measure the extent of supine positioning time. Patients are to sleep two nights with the positioning measuring device, one night with a tennis ball in the back of the night shirt and one night without. Hereby the investigators search new knowledge concerning patients compliance and verification of the "tennis ball technique".

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital, Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pars plana vitrectomy for macular hole, vitreomacular traction or epiretinal membrane where intra ocular gas tamponade is used.
  • Informed consent

Exclusion criteria

  • Age less than 18 years

Treatment and study plan

Positioning measuring device

Procedure

A tennis ball in the night shirt will prevent supine position during sleep.

Other names: Measurement of time spent in the supine position

Primary outcomes

  1. Time in supine sleeping position

    Time frame: Two days

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • Haukeland University Hospital

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2013
Registry last updated
Dec 17, 2014

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

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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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