Corneal Dystrophies, Hereditary, Corneal Transplantation, Descemet Stripping Automated Endothelial Keratoplasty, Fuchs' Endothelial Dystrophy
Conditions
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.
Interventions
OTHERPostoperative positioning: Bed rest
Patients in this group should be lying down facing up 2 hours postoperatively
OTHERPostoperative positioning: Sitting up
Patients in this group should be sitting up in a chair 2 hours postoperative
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft dislocation measured by slit lamp examination | 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
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure (IOP) | 5 years | The intraocular pressure (IOP) is measured at every postoperative control |
| Visual Acuity | 5 years | Visual Acuity is measured at every postoperative control |
| Endothelial cell count of the graft | 5 years | Endothelial cell count of the graft is measured at every postoperative control |
Countries
Norway
Contacts
Primary ContactLiv Drolsum, Prof,MD,PhD
Backup ContactMarit Sæthre, MD, PhD
Outcome results
None listed