UnknownNot Applicable

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

Germany60 participantsStarted 2011-04

Plain-language 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

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: The measurment will be performed prior to and 1, 4, 12, 24, 36, 48 and 60 months after the transplantation

Trial details

NCT IDNCT00623584

SponsorKlinikum Chemnitz gGmbH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-04

Contact for this trial

Katrin Engelmann, MD

+ 49 371 333 33230 k.engelmann@skc.de

View on ClinicalTrials.gov More Fuch's Endothelial Dystrophy trials

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.