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Air Tamponade in Macular Hole Surgery

This study is currently recruiting participants.
Verified September 2012 by Helse Stavanger HF
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01680068
First received: September 3, 2012
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
  Purpose

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 the gas tamponade will be replaced by air. Postoperative face down positioning will not be used.


Condition Intervention
Idiopathic Macular Hole Stage II - IV
 Procedure: Pars plana postoperative air tamponade

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Air Tamponade in Macular Hole Surgery

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Closure rate of macula hole [ Time Frame: 1 week after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Closure rate in macular holes larger than 400 micrometer [ Time Frame: 1 week after enrollment ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Visual gain after 6 months of follow up [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pars plana postoperative air tamponade
Pars plane vitrectomy, internal limiting membrane peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.
 Procedure: Pars plana postoperative air tamponade
Pars plane vitrectomy, internal limiting membrane peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680068

Locations
Norway
Stavanger University Hospital, Department of Ophthalmology Recruiting
Stavanger, Norway, 4026
Contact: Vegard Forsaa, MD     +47 48152212     vegard.forsaa@sus.no    
Principal Investigator: Vegard Forsaa, MD            
Sponsors and Collaborators
Helse Stavanger HF
Haukeland University Hospital
Investigators
Study Director: Vegard Forsaa, MD Helse Stavanger HF
  More Information

No publications provided

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01680068     History of Changes
Other Study ID Numbers: 2012815b
Study First Received: September 3, 2012
Last Updated: September 17, 2012
Health Authority: Norway: Ethics Committee
Norway: Data Protection Authority

Keywords provided by Helse Stavanger HF:
Macular hole
Vitreoretinal surgery
Macular surgery
Air tamponade

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013