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Comparison of Corneal Grafts Cultured in Serum-free Versus Corneal Grafts Cultured in Serum Supplemented Culture Media (SFM)

Primary Purpose

Fuch's Endothelial Dystrophy, Pseudophakic Bullous Keratopathy

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Corneal transplantation
Corneal transplantation
Sponsored by
Klinikum Chemnitz gGmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fuch's Endothelial Dystrophy focused on measuring penetrating keratoplasty, corneal transplantation, corneal grafting, corneal grafts, culture media, corneal culturing, in vitro culturing

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients between 50 and 85 years of age
  • Clinically proven Fuchs corneal dystrophy or secondary decompensation the corneal endothelium (e. g. after surgical intervention in the anterior segment of the eye)
  • Patient informed consent

Exclusion Criteria:

  • Previous penetrating keratoplasty
  • Corneal neovascularisation
  • Pathologic changes in the anterior segment of the eye (anterior / posterior synechiae, uveitis)
  • Glaucoma
  • Aphakia
  • Infectious diseases of the cornea
  • Neurodermitis
  • Participation of the patient in another clinical trial within the last four weeks that precede the recruitment
  • The patient is unlikely to comply with the requirements of the protocol
  • Previous or current abuse of medications, narcotics or alcohol
  • Pregnancy

Sites / Locations

  • Universitäts Augenklinik
  • Augenklinik, Klinikum Chemnitz gGmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Patients in this arm randomly receive a corneal graft cultured in a serum free culture medium

Patients in this arm randomly receive a corneal graft cultured in a serum supplemented culture medium

Outcomes

Primary Outcome Measures

The primary outcome is the endothelial cell density of the corneal grafts prior to and after the transplantation procedure

Secondary Outcome Measures

Secondary study outcomes are immune mediated graft rejection, non-immune mediated graft failure, as well as the incidence of corneal edema, corneal opacities and corneal neovascularisation.

Full Information

First Posted
February 13, 2008
Last Updated
December 7, 2010
Sponsor
Klinikum Chemnitz gGmbH
Collaborators
German Research Foundation, KKS Netzwerk
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1. Study Identification

Unique Protocol Identification Number
NCT00623584
Brief Title
Comparison of Corneal Grafts Cultured in Serum-free Versus Corneal Grafts Cultured in Serum Supplemented Culture Media
Acronym
SFM
Official Title
In Vitro and Clinical Comparison of Corneal Grafts Cultured in Serum Free Medium or Standard Serum Supplemented Medium in Patients With Degeneration of the Corneal Endothelium
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Klinikum Chemnitz gGmbH
Collaborators
German Research Foundation, KKS Netzwerk

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to compare the quality of corneal grafts cultured in a serum-free culture medium with a defined composition versus corneal grafts cultured in a standard serum supplemented culture medium transplanted in patients with decompensated corneal dystrophy
Detailed Description
The primary objective of this clinical trial is to test the equivalence of the quality of the corneal grafts cultured under serum free conditions to corneal grafts cultured in the Minimal Essential Medium supplemented with 2% fetal calf serum, based on a parallel comparison of the endothelial cell density of paired corneal grafts deriving from single donors at different time points before and after the grafting procedure. In addition, the safety of the clinical use of corneal grafts cultured in both media will be determined. The graft survival rate during the follow-up period will be quantified in regard to immune mediated graft rejection and non-immune mediated graft failure, as well as the incidence of corneal edema, corneal opacities and corneal neovascularisation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuch's Endothelial Dystrophy, Pseudophakic Bullous Keratopathy
Keywords
penetrating keratoplasty, corneal transplantation, corneal grafting, corneal grafts, culture media, corneal culturing, in vitro culturing

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients in this arm randomly receive a corneal graft cultured in a serum free culture medium
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients in this arm randomly receive a corneal graft cultured in a serum supplemented culture medium
Intervention Type
Procedure
Intervention Name(s)
Corneal transplantation
Intervention Description
Full thickness penetrating keratoplasty
Intervention Type
Procedure
Intervention Name(s)
Corneal transplantation
Intervention Description
Full thickness penetrating keratoplasty
Primary Outcome Measure Information:
Title
The primary outcome is the endothelial cell density of the corneal grafts prior to and after the transplantation procedure
Time Frame
The measurment will be performed prior to and 1, 4, 12, 24, 36, 48 and 60 months after the transplantation
Secondary Outcome Measure Information:
Title
Secondary study outcomes are immune mediated graft rejection, non-immune mediated graft failure, as well as the incidence of corneal edema, corneal opacities and corneal neovascularisation.
Time Frame
1,4,12, 24, 36, 48 and 60 month after the transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients between 50 and 85 years of age Clinically proven Fuchs corneal dystrophy or secondary decompensation the corneal endothelium (e. g. after surgical intervention in the anterior segment of the eye) Patient informed consent Exclusion Criteria: Previous penetrating keratoplasty Corneal neovascularisation Pathologic changes in the anterior segment of the eye (anterior / posterior synechiae, uveitis) Glaucoma Aphakia Infectious diseases of the cornea Neurodermitis Participation of the patient in another clinical trial within the last four weeks that precede the recruitment The patient is unlikely to comply with the requirements of the protocol Previous or current abuse of medications, narcotics or alcohol Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katrin Engelmann, MD
Phone
+ 49 371 333 33230
Email
k.engelmann@skc.de
First Name & Middle Initial & Last Name or Official Title & Degree
Simo Murovski, MD
Phone
+ 49 371 6000020
Email
s.murovski@poliklinik-chemnitz.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrin Engelmann, MD
Organizational Affiliation
Klinikum Chemnitz GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäts Augenklinik
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gernot Duncker, MD
Phone
+49 345 557 1878
Email
gernot.duncker@medizin.uni-halle.de
First Name & Middle Initial & Last Name & Degree
Timm Bredehorn, MD
Phone
+ 49 345 557 1575
Email
timm.bredehorn@dso.de
Facility Name
Augenklinik, Klinikum Chemnitz gGmbH
City
Chemnitz
State/Province
Saxony
ZIP/Postal Code
091116
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrin Engelmann, MD
Phone
+ 49 371 333 33230
Email
k.engelmann@skc.de
First Name & Middle Initial & Last Name & Degree
Simo Murovski, MD
Phone
+ 49 371 6000020
Email
s.murovski@poliklinik-chemnitz.de
First Name & Middle Initial & Last Name & Degree
Katrin Engelmann, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
11760044
Citation
Hempel B, Bednarz J, Engelmann K. Use of a serum-free medium for long-term storage of human corneas. Influence on endothelial cell density and corneal metabolism. Graefes Arch Clin Exp Ophthalmol. 2001 Oct;239(10):801-5. doi: 10.1007/s004170100364.
Results Reference
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PubMed Identifier
11734511
Citation
Bednarz J, Doubilei V, Wollnik PC, Engelmann K. Effect of three different media on serum free culture of donor corneas and isolated human corneal endothelial cells. Br J Ophthalmol. 2001 Dec;85(12):1416-20. doi: 10.1136/bjo.85.12.1416.
Results Reference
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PubMed Identifier
11450479
Citation
Uphoff J, Bednarz J, Engelmann K. [Follow-up of endothelial cell density after perforating keratoplasty. Effect of donor and recipient-related factors]. Ophthalmologe. 2001 Jun;98(6):550-4. doi: 10.1007/s003470170117. German.
Results Reference
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PubMed Identifier
11520760
Citation
Moller-Pedersen T, Hartmann U, Moller HJ, Ehlers N, Engelmann K. Evaluation of potential organ culture media for eye banking using human donor corneas. Br J Ophthalmol. 2001 Sep;85(9):1075-9. doi: 10.1136/bjo.85.9.1075.
Results Reference
background
PubMed Identifier
11760040
Citation
Moller-Pedersen T, Hartmann U, Ehlers N, Engelmann K. Evaluation of potential organ culture media for eye banking using a human corneal endothelial cell growth assay. Graefes Arch Clin Exp Ophthalmol. 2001 Oct;239(10):778-82. doi: 10.1007/s004170100354.
Results Reference
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Comparison of Corneal Grafts Cultured in Serum-free Versus Corneal Grafts Cultured in Serum Supplemented Culture Media

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