Air Tamponade in Macular Hole Surgery

This study has been completed.
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01680068
First received: September 3, 2012
Last updated: December 4, 2013
Last verified: December 2013
  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 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.


Condition Intervention
Macular Hole
Procedure: Pars plana vitrectomy and 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 macular hole [ Time Frame: 1 month after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Closure rate in macular holes larger than 400 micrometer [ Time Frame: 1 month 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 ]

Enrollment: 20
Study Start Date: September 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Norway
Stavanger University Hospital, Department of Ophthalmology
Stavanger, Norway, 4016
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: December 4, 2013
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 September 30, 2014