An interventional study of Postoperative air tamponade in Macular Holes, sponsored by Helse Stavanger HF. Completed at 1 site in Norway. Per ClinicalTrials.gov, last updated 2016-10-27.
Sponsored by Helse Stavanger HF · Not applicable, Interventional, and Treatment
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. Only macular holes less than 400 μm will be included.
156 studies on the registry are indexed under Retinal Perforations; 21 are open to participants now.
This study's enrollment of 13 is below the median of 44 across 104 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Helse Stavanger HF is the lead sponsor of 93 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.
Procedure: 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.
Closure rate of macular hole
Time frame: 1 month after enrollment
Visual gain after 6 months of follow up
Time frame: 6 months after enrollment
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Helse Stavanger HF