CompletedNot Applicable

Study to Evaluate the Safety of the EndoArt™ for Treatment of Subjects Suffering From Corneal Edema

Germany, Israel, Netherlands22 participantsStarted 2017-06-22

Plain-language summary

Prospective, feasibility study to evaluate the safety of the EndoArt® for treatment of 30 subjects suffering from corneal edema. Followed up for 12 months.

Who can participate

Age range

40 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

. Subject is over 40 years old
. Subject with chronic corneal edema.
. Subject with corneal thickness \>650 µm
. Subject with visual acuity 6/30 or worse (equivalent ETDRS)
. Subject with better visual acuity in the contralateral eye.
. Pseudophakic subject (anterior or posterior) with stable IOL.
. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.

Exclusion criteria

. Subject with best corrected visual acuity of 6/30 or worse in the fellow eye
. Subject with history of ocular Herpes keratitis
. Subject with severely scarred cornea (unfit for regular endothelial keratoplasty)
. Subject with irregular posterior cornea (e.g. post PKP)

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

Treatment-related adverse events

Timeframe: 6 months following EndoArt implantaion

Trial details

NCT IDNCT03069521

SponsorEye-yon Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-30

View on ClinicalTrials.gov More Chronic Cornel Edema trials