Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

Not Applicable

Terminated

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

• Registration Number: NCT02295943
• 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 have developed a positioning measuring device which can measure the extent of supine positioning time. Patients are to carry the positioning measuring device during the first postoperative 24 hours. Hereby the investigators search new knowledge concerning patients compliance and its relation to macular hole closure.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-20
• Primary Completion: 2017-11-20
• Study Completion: 2017-11-20
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• Primary macular hole
• Duration less than 24 months
• Informed consent

Exclusion Criteria

• Secondary macular hole i.e. trauma, excessive myopia (more than 6 dioptres)
• Previous vitreomacular surgery
• Age under 18 years
• Unable to sign

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Positioning measuring device	Positioning measuring device	The supine time during the first postoperative day is measured

Primary Outcome Measures

Name	Time	Method
Macular hole closure	2 weeks

Secondary Outcome Measures

Name	Time	Method
Time in supine sleeping position	1 day after enrollment

Trial Locations

Locations (4)

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Stavanger University Hospital; 🇳🇴 Stavanger, Norway

Trondheim University Hospital; 🇳🇴 Trondheim, Norway

University Hospital of North Norway; 🇳🇴 Tromsø, Norway