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Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02295943
Recruitment Status : Terminated (Could not meet primary and secondary outcome measures)
First Posted : November 20, 2014
Last Update Posted : June 6, 2018
Sponsor:
Collaborators:
Haukeland University Hospital
Trondheim University Hospital
University Hospital of North Norway
Information provided by (Responsible Party):
Helse Stavanger HF

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.

Condition or disease Intervention/treatment Phase
Macular Hole Other: Positioning measuring device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
Actual Study Start Date : November 2014
Actual Primary Completion Date : November 20, 2017
Actual Study Completion Date : November 20, 2017

Arm Intervention/treatment
Positioning measuring device
The supine time during the first postoperative day is measured
Other: Positioning measuring device
Vitrectomy, intraocular gas fill. The supine time during the first postoperative day is measured




Primary Outcome Measures :
  1. Macular hole closure [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Time in supine sleeping position [ Time Frame: 1 day after enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295943


Locations
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Norway
Haukeland University Hospital
Bergen, Norway, 5021
Stavanger University Hospital
Stavanger, Norway, 4011
University Hospital of North Norway
Tromsø, Norway, 9038
Trondheim University Hospital
Trondheim, Norway, 7030
Sponsors and Collaborators
Helse Stavanger HF
Haukeland University Hospital
Trondheim University Hospital
University Hospital of North Norway
Investigators
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Principal Investigator: Vegard Forsaa, MD Stavanger University Hospital, Department of Ophthalmology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT02295943    
Other Study ID Numbers: 2014/879
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Retinal Perforations
Retinal Diseases
Eye Diseases