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Objective 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
Helse Stavanger HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Hole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

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
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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

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Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

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