An Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
1 other identifier
observational
43
1 country
2
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".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 4, 2013
CompletedFirst Posted
Study publicly available on registry
December 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 17, 2014
December 1, 2014
1.1 years
December 4, 2013
December 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time in supine sleeping position
Two days
Study Arms (2)
Tennis ball
Night with tennis ball fastened in the back of the night shirt. A positioning measuring device mounted.
No tennis ball
Night without tennis ball fastened in the back of the night shirt. A positioning measure device mounted.
Interventions
A tennis ball in the night shirt will prevent supine position during sleep.
Eligibility Criteria
Patients undergoing pars plana vitrectomy for macular hole formation, or conditions as epiretinal menbrane or vitreomacular traction where a macular hole formation is likely.
You may qualify if:
- Pars plana vitrectomy for macular hole, vitreomacular traction or epiretinal membrane where intra ocular gas tamponade is used.
- Informed consent
You may not qualify if:
- Age less than 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helse Stavanger HFlead
- Haukeland University Hospitalcollaborator
Study Sites (2)
Haukeland University Hospital
Bergen, 5021, Norway
Stavanger University Hospital, Department of Ophthalmology
Stavanger, 4026, Norway
Related Publications (1)
Forsaa VA, Raeder S, Hashemi LT, Krohn J. Short-term postoperative non-supine positioning versus strict face-down positioning in macular hole surgery. Acta Ophthalmol. 2013 Sep;91(6):547-51. doi: 10.1111/j.1755-3768.2012.02464.x. Epub 2012 Jul 25.
PMID: 22830524BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vegard Forsaa, MD
Helse Stavanger HF
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2013
First Posted
December 13, 2013
Study Start
October 1, 2013
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
December 17, 2014
Record last verified: 2014-12