Air Tamponade in Macular Holes < 400 μm
This trial has been completed.
|Treatment||postoperative air tamponade|
|Sponsor||Helse Stavanger HF|
|Collaborator||Haukeland University Hospital|
|Start date||December 2013|
|End date||September 2015|
|Trial size||13 participants|
|Trial identifier||NCT02028481, 2012815b1|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Closure rate of macular hole
time frame: 1 month after enrollment
Male or female participants of any age.
Inclusion Criteria: - Primary macular hole less than 400 μm in diameter - Duration of symptoms less than 36 months - Informed consent Exclusion Criteria: - Previous vitreomacular surgery - Myopia more than 6 diopters - Ocular trauma - Disease affecting visual function
|Official title||Air Tamponade in Macular Holes < 400 μm|
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