Air Tamponade in Macular Hole Surgery
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ClinicalTrials.gov Identifier: NCT01680068 |
Recruitment Status :
Completed
First Posted : September 6, 2012
Last Update Posted : December 6, 2013
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Condition or disease | Intervention/treatment | Phase |
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Macular Hole | Procedure: Pars plana vitrectomy and postoperative air tamponade | Not Applicable |
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 |
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.
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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. |
- Closure rate of macular hole [ Time Frame: 1 month after enrollment ]
- Closure rate in macular holes larger than 400 micrometer [ Time Frame: 1 month after enrollment ]
- Visual gain after 6 months of follow up [ Time Frame: 6 months after enrollment ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Norway | |
Stavanger University Hospital, Department of Ophthalmology | |
Stavanger, Norway, 4016 |
Study Director: | Vegard Forsaa, MD | Helse Stavanger HF |
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 |
Macular hole Vitreoretinal surgery Macular surgery Air tamponade |
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