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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02295943
Date of registration:	17/11/2014
Prospective Registration:	No
Primary sponsor:	Helse Stavanger HF
Public title:	Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
Scientific title:	Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
Date of first enrolment:	November 2014
Target sample size:	205
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT02295943
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Norway

Contacts

Name:	Vegard Forsaa, MD
Address:
Telephone:
Email:
Affiliation:	Stavanger University Hospital, Department of Ophthalmology

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Macular Hole

Intervention(s)

Other: Positioning measuring device

Primary Outcome(s)

Macular hole closure [Time Frame: 2 weeks]

Secondary Outcome(s)

Time in supine sleeping position [Time Frame: 1 day after enrollment]

Secondary ID(s)

2014/879

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital of North Norway

Trondheim University Hospital

Haukeland University Hospital

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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