Fuch's Endothelial DystrophySFMNCT00623584
Comparison of Corneal Grafts Cultured in Serum-free Versus Corneal Grafts Cultured in Serum Supplemented Culture Media
A study testing Corneal transplantation in people with Fuch's Endothelial Dystrophy and Pseudophakic Bullous Keratopathy, run by Klinikum Chemnitz gGmbH at 2 sites in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Fuch's Endothelial Dystrophy, Pseudophakic Bullous Keratopathy
- What is being tested?
- Corneal transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Augenklinik, Klinikum Chemnitz gGmbH
Chemnitz, Saxony, 091116
Katrin Engelmann, MD, + 49 371 333 33230, k.engelmann@skc.de
Simo Murovski, MD, + 49 371 6000020, s.murovski@poliklinik-chemnitz.de
Universitäts Augenklinik
Halle, Saxony-Anhalt, 06120
Gernot Duncker, MD, +49 345 557 1878, gernot.duncker@medizin.uni-halle.de
Timm Bredehorn, MD, + 49 345 557 1575, timm.bredehorn@dso.de
About this study
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
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
Read the 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.
- Being tested
- Corneal transplantation
- Keywords
- penetrating keratoplasty, corneal transplantation, corneal grafting, corneal grafts, culture media, corneal culturing, in vitro culturing
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal transplantationProcedure or surgery
Full thickness penetrating keratoplasty
Corneal transplantationProcedure or surgery
Full thickness penetrating keratoplasty
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients in this arm randomly receive a corneal graft cultured in a serum free culture medium Receives: Procedure: Corneal transplantation |
| 2 | Active comparator | Patients in this arm randomly receive a corneal graft cultured in a serum supplemented culture medium Receives: Procedure: Corneal transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the endothelial cell density of the corneal grafts prior to and after the transplantation procedure
Measured: The measurment will be performed prior to and 1, 4, 12, 24, 36, 48 and 60 months after the transplantation
Secondary outcomes (1)
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.
Measured: 1,4,12, 24, 36, 48 and 60 month after the transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startApr 2011
- Primary completionApr 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fuch's Endothelial DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum Chemnitz gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, KKS Netzwerk
- Investigators
- Katrin Engelmann, MD, Principal investigator, Klinikum Chemnitz GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623584
- Sponsor's protocol ID
- SKC001SFM08
- Acronym
- SFM
- Status last verified
- Dec 2010
- First submitted
- 13 Feb 2008
- Last updated
- 8 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11760044Bednarz 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.
PubMed 11734511Uphoff 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.
PubMed 11450479Moller-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.
PubMed 11520760Moller-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.
PubMed 11760040
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00623584
- Acronym / sponsor ID
- SFM / SKC001SFM08
- Keywords
- penetrating keratoplasty, corneal transplantation, corneal grafting, corneal grafts, culture media, corneal culturing, in vitro culturing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Klinikum Chemnitz gGmbHUniversity, hospital or other
- Collaborators
- German Research Foundation, KKS Netzwerk
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 26 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Corneal transplantationPatients in this arm randomly receive a corneal graft cultured in a serum free culture medium |
| 2 | Active comparator | Procedure: Corneal transplantationPatients in this arm randomly receive a corneal graft cultured in a serum supplemented culture medium |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Previous penetrating keratoplasty
- Corneal neovascularisation
- Pathologic changes in the anterior segment of the eye (anterior / posterior synechiae, uveitis)
- Glaucoma
- Aphakia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corneal transplantationFull thickness penetrating keratoplasty | Procedure or surgery | 1 |
| Corneal transplantationFull thickness penetrating keratoplasty | Procedure or surgery | 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2010.
- Background: PubMed 11760044Hempel 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.
- Background: PubMed 11734511Bednarz 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.
- Background: PubMed 11450479Uphoff 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.
- Background: PubMed 11520760Moller-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.
- Background: PubMed 11760040Moller-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrin Engelmann, MD principal investigator
Klinikum Chemnitz GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal transplantation in people with Fuch's Endothelial Dystrophy and Pseudophakic Bullous Keratopathy, run by Klinikum Chemnitz gGmbH at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrin Engelmann, MD (+ 49 371 333 33230, k.engelmann@skc.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00623584, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2010.