Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02295943

Enrollment

205

Registered

2014-11-20

Start date

2014-11-30

Completion date

2017-11-20

Last updated

2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Hole

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.

Interventions

OTHERPositioning measuring device

Vitrectomy, intraocular gas fill. The supine time during the first postoperative day is measured

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Macular hole closure	2 weeks

Secondary

Measure	Time frame
Time in supine sleeping position	1 day after enrollment

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026