ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Macular Hole Procedure: Pars plana vitrectomy and postoperative air tamponade Not Applicable

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Air Tamponade in Macular Hole Surgery
Study Start Date : September 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013
Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

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

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01680068     History of Changes
Other Study ID Numbers: 2012815b
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013

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

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases
Temazepam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action