DSAEK- Postoperative Positioning and Transplant Dislocation

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2010 by Oslo University Hospital
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01206127
First received: September 20, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

September 20, 2010
September 20, 2010
September 2010
January 2018   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
DSAEK- Postoperative Positioning and Transplant Dislocation
DSAEK- Postoperative Positioning and Transplant Dislocation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Corneal Transplantation
  • Descemet Stripping Automated Endothelial Keratoplasty
  • Fuchs' Endothelial Dystrophy
  • Corneal Dystrophies, Hereditary
  • 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 postoperative
  • Postoperative positioning: Bed rest
    Patients in this group must be lying down facing up 2 hours postoperatively
    Intervention: Other: Postoperative positioning: Bed rest
  • Postoperative positioning: Sitting up
    Patients in this group should be sitting up in a chair 2 hours postoperatively
    Intervention: Other: Postoperative positioning: Sitting up

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
January 2018
January 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
 
NCT01206127
239-08/344c(REK)-1
No
Prof. Liv Drolsum, MD, PhD, Department of Ophthalmology, Oslo University Hospital Ullevål, Norway
Oslo University Hospital
Not Provided
Study Director: Liv Drolsum, Prof.,MD,PhD Department of Ophthalmology, Oslo University Hospital, Norway
Oslo University Hospital
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP