Back to resultsObjective Evaluation of Postoperative Positioning in Macular Hole Surgery
Primary Purpose
Macular Hole
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Positioning measuring device
Sponsored by
About this trial
This is an interventional treatment trial for Macular Hole
Eligibility Criteria
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
Sites / Locations
- Haukeland University Hospital
- Stavanger University Hospital
- University Hospital of North Norway
- Trondheim University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Positioning measuring device
Arm Description
The supine time during the first postoperative day is measured
Outcomes
Primary Outcome Measures
Macular hole closure
Secondary Outcome Measures
Time in supine sleeping position
Full Information
NCT ID
NCT02295943
First Posted
November 17, 2014
Last Updated
June 4, 2018
Sponsor
Helse Stavanger HF
Collaborators
Haukeland University Hospital, Trondheim University Hospital, University Hospital of North Norway
1. Study Identification
Unique Protocol Identification Number
NCT02295943
Brief Title
Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
Official Title
Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Could not meet primary and secondary outcome measures
Study Start Date
November 2014 (Actual)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
Collaborators
Haukeland University Hospital, Trondheim University Hospital, University Hospital of North Norway
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Hole
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positioning measuring device
Arm Type
Other
Arm Description
The supine time during the first postoperative day is measured
Intervention Type
Other
Intervention Name(s)
Positioning measuring device
Intervention Description
Vitrectomy, intraocular gas fill. The supine time during the first postoperative day is measured
Primary Outcome Measure Information:
Title
Macular hole closure
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Time in supine sleeping position
Time Frame
1 day after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vegard Forsaa, MD
Organizational Affiliation
Stavanger University Hospital, Department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Stavanger University Hospital
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
University Hospital of North Norway
City
Tromsø
ZIP/Postal Code
9038
Country
Norway
Facility Name
Trondheim University Hospital
City
Trondheim
ZIP/Postal Code
7030
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31044728
Citation
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.
Results Reference
derived
Learn more about this trial
Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
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