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An Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

An Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02011165
Enrollment
43
Registered
2013-12-13
Start date
2013-10-31
Completion date
2014-12-31
Last updated
2014-12-17

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

Conditions

Macular Hole

Keywords

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

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.

Interventions

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

Sponsors

Haukeland University Hospital
CollaboratorOTHER
Helse Stavanger HF
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time in supine sleeping positionTwo days

Countries

Norway

Outcome results

None listed

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