Clinical trial NCT01206127: DSAEK- Postoperative Positioning and Transplant Dislocation
Official title: DSAEK- Postoperative Positioning and Transplant Dislocation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Corneal Transplantation
Descemet Stripping Automated Endothelial Keratoplasty
Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Corneal transplant is a surgical procedure where a damaged or diseased cornea is replaced by donated corneal tissue (the graft) in its entirety (penetrating keratoplasty) or in part (lamellar keratoplasty). One type of lamellar keratoplasty is DSAEK (Descemet's Stripping Automated Endothelial Keratoplasty), where only the damaged posterior section of the cornea is replaced.

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: Corneal transplant is a surgical procedure where a damaged or diseased cornea is replaced by donated corneal tissue (the graft) in its entirety (penetrating keratoplasty) or in part (lamellar keratoplasty). One type of lamellar keratoplasty is DSAEK (Descemet's Stripping Automated Endothelial Keratoplasty), where only the damaged posterior section of the cornea is replaced.

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.

Eligibility criteria: Inclusion Criteria:

* Corneal dystrophy requiring corneal transplantation
* Patients written permission
* Pseudophakia

Exclusion Criteria:

* Uncontrolled glaucoma
* Phakia or aphakia
* Shallow anterior chamber
* Fibrotic cornea
* Demented patients
* Claustrophobic patients
* Patients that do not want to participate

Primary outcomes:
measure: Graft dislocation measured by slit lamp examination
timeFrame: 5 years
Secondary outcomes:
measure: Intraocular pressure (IOP)
timeFrame: 5 years
measure: Visual Acuity
timeFrame: 5 years
measure: Endothelial cell count of the graft
timeFrame: 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Departement of Ophthalmology, Oslo University Hospital, Norway
Study officials:
affiliation: Department of Ophthalmology, Oslo University Hospital, Norway
name: Liv Drolsum, Prof.,MD,PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.