DSAEK- Postoperative Positioning and Transplant Dislocation

This study is currently recruiting participants.

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

Tracking Information

First Received Date ^ICMJE

September 20, 2010

Last Updated Date

September 20, 2010

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

January 2018 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

DSAEK- Postoperative Positioning and Transplant Dislocation

Official Title ^ICMJE

DSAEK- Postoperative Positioning and Transplant Dislocation

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Corneal Transplantation
Descemet Stripping Automated Endothelial Keratoplasty
Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2018

Estimated Primary Completion Date

January 2018 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT01206127

Other Study ID Numbers ^ICMJE

239-08/344c(REK)-1

Has Data Monitoring Committee

Responsible Party

Prof. Liv Drolsum, MD, PhD, Department of Ophthalmology, Oslo University Hospital Ullevål, Norway

Study Sponsor ^ICMJE

Oslo University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Liv Drolsum, Prof.,MD,PhD

Department of Ophthalmology, Oslo University Hospital, Norway

Information Provided By

Oslo University Hospital

Verification Date

September 2010

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

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