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DSAEK- Postoperative Positioning and Transplant Dislocation

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Postoperative positioning: Bed rest
Postoperative positioning: Sitting up
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Departement of Ophthalmology, Oslo University Hospital, NorwayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Postoperative positioning: Bed rest

Postoperative positioning: Sitting up

Arm Description

Patients in this group must be lying down facing up 2 hours postoperatively

Patients in this group should be sitting up in a chair 2 hours postoperatively

Outcomes

Primary Outcome Measures

Graft dislocation measured by slit lamp examination
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)
The intraocular pressure (IOP) is measured at every postoperative control
Visual Acuity
Visual Acuity is measured at every postoperative control
Endothelial cell count of the graft
Endothelial cell count of the graft is measured at every postoperative control

Full Information

First Posted
September 20, 2010
Last Updated
September 20, 2010
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01206127
Brief Title
DSAEK- Postoperative Positioning and Transplant Dislocation
Official Title
DSAEK- Postoperative Positioning and Transplant Dislocation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Transplantation, Descemet Stripping Automated Endothelial Keratoplasty, Fuchs' Endothelial Dystrophy, Corneal Dystrophies, Hereditary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Postoperative positioning: Bed rest
Arm Type
Other
Arm Description
Patients in this group must be lying down facing up 2 hours postoperatively
Arm Title
Postoperative positioning: Sitting up
Arm Type
Other
Arm Description
Patients in this group should be sitting up in a chair 2 hours postoperatively
Intervention Type
Other
Intervention Name(s)
Postoperative positioning: Bed rest
Intervention Description
Patients in this group should be lying down facing up 2 hours postoperatively
Intervention Type
Other
Intervention Name(s)
Postoperative positioning: Sitting up
Intervention Description
Patients in this group should be sitting up in a chair 2 hours postoperative
Primary Outcome Measure Information:
Title
Graft dislocation measured by slit lamp examination
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Intraocular pressure (IOP)
Description
The intraocular pressure (IOP) is measured at every postoperative control
Time Frame
5 years
Title
Visual Acuity
Description
Visual Acuity is measured at every postoperative control
Time Frame
5 years
Title
Endothelial cell count of the graft
Description
Endothelial cell count of the graft is measured at every postoperative control
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liv Drolsum, Prof,MD,PhD
Phone
+47 22 11 85 45
Email
LivKari.Drolsum@ulleval.no
First Name & Middle Initial & Last Name or Official Title & Degree
Marit Sæthre, MD, PhD
Phone
+47 22 11 85 45
Email
marit.sathre@medisin.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liv Drolsum, Prof.,MD,PhD
Organizational Affiliation
Department of Ophthalmology, Oslo University Hospital, Norway
Official's Role
Study Director
Facility Information:
Facility Name
Departement of Ophthalmology, Oslo University Hospital, Norway
City
Oslo
ZIP/Postal Code
N-0407
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liv Drolsum, Prof.,MD,PhD
Phone
+47 22 11 85 45
Email
LivKari.Drolsum@ulleval.no
First Name & Middle Initial & Last Name & Degree
Marit Sæthre, MD, PhD
Phone
+47 22 11 85 45
Email
marit.sathre@medisin.uio.no

12. IPD Sharing Statement

Citations:
PubMed Identifier
20031230
Citation
Price MO, Gorovoy M, Benetz BA, Price FW Jr, Menegay HJ, Debanne SM, Lass JH. Descemet's stripping automated endothelial keratoplasty outcomes compared with penetrating keratoplasty from the Cornea Donor Study. Ophthalmology. 2010 Mar;117(3):438-44. doi: 10.1016/j.ophtha.2009.07.036. Epub 2010 Jan 19.
Results Reference
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PubMed Identifier
19875170
Citation
Price MO, Giebel AW, Fairchild KM, Price FW Jr. Descemet's membrane endothelial keratoplasty: prospective multicenter study of visual and refractive outcomes and endothelial survival. Ophthalmology. 2009 Dec;116(12):2361-8. doi: 10.1016/j.ophtha.2009.07.010. Epub 2009 Oct 28.
Results Reference
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PubMed Identifier
19417653
Citation
Dapena I, Ham L, Melles GR. Endothelial keratoplasty: DSEK/DSAEK or DMEK--the thinner the better? Curr Opin Ophthalmol. 2009 Jul;20(4):299-307. doi: 10.1097/ICU.0b013e32832b8d18.
Results Reference
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DSAEK- Postoperative Positioning and Transplant Dislocation

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