DSAEK- Postoperative Positioning and Transplant Dislocation
NCT ID: NCT01206127
Last Updated: 2010-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2010-09-30
2018-01-31
Brief Summary
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The purpose of this study is to investigate how immediate postoperative positioning of the patient affects the dislocation rate of the corneal graft. Since this is a new surgical method, little scientific documentation has been published in this area.
Detailed Description
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To get the graft in the right position inside the eyes anterior chamber, the anterior chamber is fully filled with air, and the patient is placed in a supine position looking facing up for different amount of time depending on the surgeon. In this way the air bubble will press the graft in the right position and prevent dislocation. Our experience is that since the anterior chamber of the eye already is fully filled with air, it does not matter how the patient is positioned postoperatively regarding graft dislocation.
Our hypothesis is that the immediate postoperative positioning is insignificant. If this can be significantly proved this may enhance the patients comfort postoperatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Postoperative positioning: Bed rest
Patients in this group must be lying down facing up 2 hours postoperatively
Postoperative positioning: Bed rest
Patients in this group should be lying down facing up 2 hours postoperatively
Postoperative positioning: Sitting up
Patients in this group should be sitting up in a chair 2 hours postoperatively
Postoperative positioning: Sitting up
Patients in this group should be sitting up in a chair 2 hours postoperative
Interventions
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Postoperative positioning: Bed rest
Patients in this group should be lying down facing up 2 hours postoperatively
Postoperative positioning: Sitting up
Patients in this group should be sitting up in a chair 2 hours postoperative
Eligibility Criteria
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Inclusion Criteria
* Patients written permission
* Pseudophakia
Exclusion Criteria
* Phakia or aphakia
* Shallow anterior chamber
* Fibrotic cornea
* Demented patients
* Claustrophobic patients
* Patients that do not want to participate
18 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Department of Ophthalmology, Oslo University Hospital Ullevål, Norway
Principal Investigators
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Liv Drolsum, Prof.,MD,PhD
Role: STUDY_DIRECTOR
Department of Ophthalmology, Oslo University Hospital, Norway
Locations
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Departement of Ophthalmology, Oslo University Hospital, Norway
Oslo, Oslo County, Norway
Countries
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Central Contacts
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Facility Contacts
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References
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Price MO, Gorovoy M, Benetz BA, Price FW Jr, Menegay HJ, Debanne SM, Lass JH. Descemet's stripping automated endothelial keratoplasty outcomes compared with penetrating keratoplasty from the Cornea Donor Study. Ophthalmology. 2010 Mar;117(3):438-44. doi: 10.1016/j.ophtha.2009.07.036. Epub 2010 Jan 19.
Price MO, Giebel AW, Fairchild KM, Price FW Jr. Descemet's membrane endothelial keratoplasty: prospective multicenter study of visual and refractive outcomes and endothelial survival. Ophthalmology. 2009 Dec;116(12):2361-8. doi: 10.1016/j.ophtha.2009.07.010. Epub 2009 Oct 28.
Dapena I, Ham L, Melles GR. Endothelial keratoplasty: DSEK/DSAEK or DMEK--the thinner the better? Curr Opin Ophthalmol. 2009 Jul;20(4):299-307. doi: 10.1097/ICU.0b013e32832b8d18.
Other Identifiers
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239-08/344c(REK)-1
Identifier Type: -
Identifier Source: org_study_id