Air Tamponade in Macular Hole Surgery
This study has been completed.
Sponsor:
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01680068
First Posted: September 6, 2012
Last Update Posted: December 6, 2013
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Helse Stavanger HF
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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: | Intervention Model: Single Group Assignment Masking: None (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 ]
Secondary Outcome Measures:
- Closure rate in macular holes larger than 400 micrometer [ Time Frame: 1 month after enrollment ]
Other Outcome Measures:
- Visual gain after 6 months of follow up [ Time Frame: 6 months after enrollment ]
| 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
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| 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
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
| Responsible Party: | Helse Stavanger HF |
| ClinicalTrials.gov Identifier: | NCT01680068 History of Changes |
| Other Study ID Numbers: |
2012815b |
| First Submitted: | September 3, 2012 |
| First Posted: | September 6, 2012 |
| 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 |