DSAEK- Postoperative Positioning and Transplant Dislocation

Sponsor
Oslo University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01206127
Collaborator
(none)
40
1
2
88
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Postoperative positioning: Bed rest
  • Other: Postoperative positioning: Sitting up
N/A

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
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
DSAEK- Postoperative Positioning and Transplant Dislocation
Study Start Date :
Sep 1, 2010
Anticipated Primary Completion Date :
Jan 1, 2018
Anticipated Study Completion Date :
Jan 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Other: 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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Intraocular pressure (IOP) [5 years]

    The intraocular pressure (IOP) is measured at every postoperative control

  2. Visual Acuity [5 years]

    Visual Acuity is measured at every postoperative control

  3. Endothelial cell count of the graft [5 years]

    Endothelial cell count of the graft is measured at every postoperative control

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Departement of Ophthalmology, Oslo University Hospital, Norway Oslo Norway N-0407

Sponsors and Collaborators

  • Oslo University Hospital

Investigators

  • Study Director: Liv Drolsum, Prof.,MD,PhD, Department of Ophthalmology, Oslo University Hospital, Norway

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01206127
Other Study ID Numbers:
  • 239-08/344c(REK)-1
First Posted:
Sep 21, 2010
Last Update Posted:
Sep 21, 2010
Last Verified:
Sep 1, 2010

Study Results

No Results Posted as of Sep 21, 2010