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Trial record 21 of 1068 for:    scale | Norway

Air Tamponade in Macular Holes < 400 μm

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ClinicalTrials.gov Identifier: NCT02028481
Recruitment Status : Completed
First Posted : January 7, 2014
Last Update Posted : October 27, 2016
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Helse Stavanger HF

Brief Summary:
Macular hole is a hole formation which takes place in the center of the retina. Such a hole needs surgical steps in order to close. Closure of the macular hole will lead to a substantially improvement of vision in most cases. Following macular hole surgery a tamponade of intraocular gas is normally injected in order to keep the macula dry for the postoperative period. Postoperative face down position for a week was earlier standard. Several authors report of good closure rates with both air tamponade or lack of face down positioning. In this study standard pars plana vitrectomy with peeling of the internal limiting membrane (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down positioning will not be used. Only macular holes less than 400 μm will be included.

Condition or disease Intervention/treatment Phase
Macular Holes Procedure: Postoperative air tamponade Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Air Tamponade in Macular Holes < 400 μm
Study Start Date : December 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: Postoperative air tamponade
Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.
Procedure: Postoperative air tamponade
Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.




Primary Outcome Measures :
  1. Closure rate of macular hole [ Time Frame: 1 month after enrollment ]

Other Outcome Measures:
  1. Visual gain after 6 months of follow up [ Time Frame: 6 months after enrollment ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary macular hole less than 400 μm in diameter
  • Duration of symptoms less than 36 months
  • Informed consent

Exclusion Criteria:

  • Previous vitreomacular surgery
  • Myopia more than 6 diopters
  • Ocular trauma
  • Disease affecting visual function

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): NCT02028481


Locations
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Norway
Stavanger University Hospital, Department of Ophthalmology
Stavanger, Norway, 4016
Sponsors and Collaborators
Helse Stavanger HF
Haukeland University Hospital
Investigators
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Study Director: Vegard Forsaa, MD Helse Stavanger HF

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Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT02028481     History of Changes
Other Study ID Numbers: 2012815b1
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Helse Stavanger HF:
Macular hole
Vitreoretinal surgery
Macular surgery
Air tamponade
Additional relevant MeSH terms:
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Retinal Perforations
Retinal Diseases
Eye Diseases