DSAEK- Postoperative Positioning and Transplant Dislocation
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Corneal Transplantation Descemet Stripping Automated Endothelial Keratoplasty Fuchs' Endothelial Dystrophy Corneal Dystrophies, Hereditary |
Other: Postoperative positioning: Bed rest Other: Postoperative positioning: Sitting up |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | DSAEK- Postoperative Positioning and Transplant Dislocation |
- Graft dislocation measured by slit lamp examination [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
- Intraocular pressure (IOP) [ Time Frame: 5 years ] [ Designated as safety issue: No ]The intraocular pressure (IOP) is measured at every postoperative control
- Visual Acuity [ Time Frame: 5 years ] [ Designated as safety issue: No ]Visual Acuity is measured at every postoperative control
- Endothelial cell count of the graft [ Time Frame: 5 years ] [ Designated as safety issue: No ]Endothelial cell count of the graft is measured at every postoperative control
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | January 2018 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Postoperative positioning: Bed rest
Patients in this group must be lying down facing up 2 hours postoperatively
|
Other: 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
|
Other: Postoperative positioning: Sitting up
Patients in this group should be sitting up in a chair 2 hours postoperative
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Liv Drolsum, Prof,MD,PhD | +47 22 11 85 45 | LivKari.Drolsum@ulleval.no |
| Contact: Marit Sæthre, MD, PhD | +47 22 11 85 45 | marit.sathre@medisin.uio.no |
| Norway | |
| Departement of Ophthalmology, Oslo University Hospital, Norway | Recruiting |
| Oslo, Norway, N-0407 | |
| Contact: Liv Drolsum, Prof.,MD,PhD +47 22 11 85 45 LivKari.Drolsum@ulleval.no | |
| Contact: Marit Sæthre, MD, PhD +47 22 11 85 45 marit.sathre@medisin.uio.no | |
| Study Director: | Liv Drolsum, Prof.,MD,PhD | Department of Ophthalmology, Oslo University Hospital, Norway |
More Information
Publications:
| Responsible Party: | Prof. Liv Drolsum, MD, PhD, Department of Ophthalmology, Oslo University Hospital Ullevål, Norway |
| ClinicalTrials.gov Identifier: | NCT01206127 History of Changes |
| Other Study ID Numbers: | 239-08/344c(REK)-1 |
| Study First Received: | September 20, 2010 |
| Last Updated: | September 20, 2010 |
| Health Authority: | Norway: Oslo University Hospital, Ulleval, department of research (FoU) Norway:National Committee for Medical and Health Research Ethics Norway: Directorate of Health Norway: Norwegian Social Science Data Services |
Additional relevant MeSH terms:
|
Corneal Dystrophies, Hereditary Dislocations Fuchs' Endothelial Dystrophy Corneal Diseases |
Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013