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An Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

NCT ID: NCT02011165

Last Updated: 2014-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

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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".

Detailed Description

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Conditions

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Macular Hole

Keywords

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Macular hole Vitrectomy Gas tamponade Vitreomacular traction in danger of macular hole formation Epiretinal membrane in danger of macular hole formation

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Tennis ball

Night with tennis ball fastened in the back of the night shirt. A positioning measuring device mounted.

Positioning measuring device

Intervention Type PROCEDURE

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

No tennis ball

Night without tennis ball fastened in the back of the night shirt. A positioning measure device mounted.

Positioning measuring device

Intervention Type PROCEDURE

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

Interventions

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Positioning measuring device

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

Intervention Type PROCEDURE

Other Intervention Names

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Measurement of time spent in the supine position

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vegard Forsaa, MD

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Stavanger University Hospital, Department of Ophthalmology

Stavanger, , Norway

Site Status

Countries

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Norway

References

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Forsaa VA, Raeder S, Hashemi LT, Krohn J. Short-term postoperative non-supine positioning versus strict face-down positioning in macular hole surgery. Acta Ophthalmol. 2013 Sep;91(6):547-51. doi: 10.1111/j.1755-3768.2012.02464.x. Epub 2012 Jul 25.

Reference Type BACKGROUND
PMID: 22830524 (View on PubMed)

Other Identifiers

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REK2013/781

Identifier Type: -

Identifier Source: org_study_id