Study Stopped
Could not meet primary and secondary outcome measures
Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
1 other identifier
interventional
205
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 17, 2014
CompletedFirst Posted
Study publicly available on registry
November 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2017
CompletedJune 6, 2018
June 1, 2018
3.1 years
November 17, 2014
June 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Macular hole closure
2 weeks
Secondary Outcomes (1)
Time in supine sleeping position
1 day after enrollment
Study Arms (1)
Positioning measuring device
OTHERThe supine time during the first postoperative day is measured
Interventions
Vitrectomy, intraocular gas fill. The supine time during the first postoperative day is measured
Eligibility Criteria
You may qualify if:
- Primary macular hole
- Duration less than 24 months
- Informed consent
You may not qualify if:
- Secondary macular hole i.e. trauma, excessive myopia (more than 6 dioptres)
- Previous vitreomacular surgery
- Age under 18 years
- Unable to sign
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helse Stavanger HFlead
- Haukeland University Hospitalcollaborator
- Trondheim University Hospitalcollaborator
- University Hospital of North Norwaycollaborator
Study Sites (4)
Haukeland University Hospital
Bergen, 5021, Norway
Stavanger University Hospital
Stavanger, 4011, Norway
University Hospital of North Norway
Tromsø, 9038, Norway
Trondheim University Hospital
Trondheim, 7030, Norway
Related Publications (1)
Lindtjorn B, Krohn J, Austeng D, Fossen K, Varhaug P, Basit S, Helgesen OH, Eide GE, Forsaa VA. Nonsupine Positioning after Macular Hole Surgery: A Prospective Multicenter Study. Ophthalmol Retina. 2019 May;3(5):388-392. doi: 10.1016/j.oret.2018.12.006. Epub 2018 Dec 31.
PMID: 31044728DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vegard Forsaa, MD
Stavanger University Hospital, Department of Ophthalmology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2014
First Posted
November 20, 2014
Study Start
November 1, 2014
Primary Completion
November 20, 2017
Study Completion
November 20, 2017
Last Updated
June 6, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share