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

NCT ID: NCT00623584

Last Updated: 2010-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Fuch's Endothelial Dystrophy Pseudophakic Bullous Keratopathy

Keywords

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penetrating keratoplasty corneal transplantation corneal grafting corneal grafts culture media corneal culturing in vitro culturing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

Corneal transplantation

Intervention Type PROCEDURE

Full thickness penetrating keratoplasty

2

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

Group Type ACTIVE_COMPARATOR

Corneal transplantation

Intervention Type PROCEDURE

Full thickness penetrating keratoplasty

Interventions

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Corneal transplantation

Full thickness penetrating keratoplasty

Intervention Type PROCEDURE

Corneal transplantation

Full thickness penetrating keratoplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

KKS Netzwerk

NETWORK

Sponsor Role collaborator

Klinikum Chemnitz gGmbH

OTHER

Sponsor Role lead

Responsible Party

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Eye Clinic Chemnitz

Principal Investigators

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Katrin Engelmann, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Chemnitz GmbH

Locations

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Augenklinik, Klinikum Chemnitz gGmbH

Chemnitz, Saxony, Germany

Site Status

Universitäts Augenklinik

Halle, Saxony-Anhalt, Germany

Site Status

Countries

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Germany

Central Contacts

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Katrin Engelmann, MD

Role: CONTACT

Phone: + 49 371 333 33230

Email: [email protected]

Simo Murovski, MD

Role: CONTACT

Phone: + 49 371 6000020

Email: [email protected]

Facility Contacts

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Katrin Engelmann, MD

Role: primary

Simo Murovski, MD

Role: backup

Gernot Duncker, MD

Role: primary

Timm Bredehorn, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 11760044 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11734511 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11450479 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11520760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11760040 (View on PubMed)

Other Identifiers

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SKC001SFM08

Identifier Type: -

Identifier Source: org_study_id