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Trial record 22 of 1066 for:    scale | Norway

Air Tamponade 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: NCT01680068
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : December 6, 2013
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Helse Stavanger HF

Tracking Information
First Submitted Date  ICMJE September 3, 2012
First Posted Date  ICMJE September 6, 2012
Last Update Posted Date December 6, 2013
Study Start Date  ICMJE September 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
Closure rate of macular hole [ Time Frame: 1 month after enrollment ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2012)
Closure rate of macula hole [ Time Frame: 1 week after enrollment ]
Change History Complete list of historical versions of study NCT01680068 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
Closure rate in macular holes larger than 400 micrometer [ Time Frame: 1 month after enrollment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2012)
Closure rate in macular holes larger than 400 micrometer [ Time Frame: 1 week after enrollment ]
Current Other Pre-specified Outcome Measures
 (submitted: September 3, 2012)
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 Hole Surgery
Official Title  ICMJE Air Tamponade in Macular Hole Surgery
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.
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 Hole
Intervention  ICMJE Procedure: Pars plana vitrectomy and postoperative air tamponade
Pars plans vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.
Study Arms  ICMJE Experimental: Pars plana vitrectomy and 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: Pars plana vitrectomy and 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: December 4, 2013)
20
Original Estimated Enrollment  ICMJE
 (submitted: September 3, 2012)
50
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Idiopathic stage 2 - 4 macular hole
  • Duration of symptoms ≤ 36 months
  • Informed consent

Exclusion Criteria:

  • Previous vitreomacular surgery
  • Myopia ≥ 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 NCT01680068
Other Study ID Numbers  ICMJE 2012815b
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 December 2013

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