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Trial record 22 of 1096 for:    scale | Norway

Air Tamponade in Macular Holes < 400 μm

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: 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

Tracking Information
First Submitted Date  ICMJE January 3, 2014
First Posted Date  ICMJE January 7, 2014
Last Update Posted Date October 27, 2016
Study Start Date  ICMJE December 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2014)
Closure rate of macular hole [ Time Frame: 1 month after enrollment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 3, 2014)
Visual gain after 6 months of follow up [ Time Frame: 6 months after enrollment ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Air Tamponade in Macular Holes < 400 μm
Official Title  ICMJE Air Tamponade in Macular Holes < 400 μm
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Macular Holes
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Procedure: Postoperative air tamponade
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2014)
13
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02028481
Other Study ID Numbers  ICMJE 2012815b1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Helse Stavanger HF
Study Sponsor  ICMJE Helse Stavanger HF
Collaborators  ICMJE Haukeland University Hospital
Investigators  ICMJE
Study Director: Vegard Forsaa, MD Helse Stavanger HF
PRS Account Helse Stavanger HF
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP