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
  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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206127

Contacts
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

Locations
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   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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 July 23, 2014