Status:
UNKNOWN
Comparison of Corneal Grafts Cultured in Serum-free Versus Corneal Grafts Cultured in Serum Supplemented Culture Media
Lead Sponsor:
Klinikum Chemnitz gGmbH
Collaborating Sponsors:
German Research Foundation
KKS Netzwerk
Conditions:
Fuch's Endothelial Dystrophy
Pseudophakic Bullous Keratopathy
Eligibility:
All Genders
50-85 years
Phase:
NA
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 supple...
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 Me...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00623584
Start Date
April 1 2011
End Date
October 1 2012
Last Update
December 8 2010
Active Locations (2)
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1
Augenklinik, Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany, 091116
2
Universitäts Augenklinik
Halle, Saxony-Anhalt, Germany, 06120