An Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

Completed

• Conditions: Macular Hole
• Interventions: Procedure: Positioning measuring device

• Registration Number: NCT02011165
• Lead Sponsor: Helse Stavanger HF

Brief Summary

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

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-13
• Primary Completion: 2014-11
• Status Verified: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tennis ball	Positioning measuring device	Night with tennis ball fastened in the back of the night shirt. A positioning measuring device mounted.
No tennis ball	Positioning measuring device	Night without tennis ball fastened in the back of the night shirt. A positioning measure device mounted.

Primary Outcome Measures

Name	Time	Method
Time in supine sleeping position	Two days

Trial Locations

Locations (2)

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Stavanger University Hospital, Department of Ophthalmology; 🇳🇴 Stavanger, Norway