Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

Helse Stavanger HF

Status: Terminated

Conditions: Macular Hole

Treatments: Other: Positioning measuring device

Study type: Interventional

Funder types: Other

Identifiers

NCT02295943

2014/879

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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205 participants in 1 patient group

Positioning measuring device

Other group

Description:

The supine time during the first postoperative day is measured

Treatment:

Other: Positioning measuring device