DSAEK- Postoperative Positioning and Transplant Dislocation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Graft dislocation measured by slit lamp examination
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Graft dislocation measured by slit lamp examination
Time Frame: 5 years
Graft dislocation is checked 2 hours postoperatively, they day after the surgery, 1 week after, 1 month, and then every 3. month for 1 year, and then every 6. months for 5 years.
Secondary Outcomes
- Intraocular pressure (IOP)(5 years)
- Visual Acuity(5 years)
- Endothelial cell count of the graft(5 years)