CompletedNot Applicable

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

Germany, Israel22 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 range40 Years

SexALL

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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)
✕. Subject who is suffering from infection of the cornea
✕. Patients with band keratopathy and/or limbal stem cell deficiency.
✕. Subject with clinical moderate to severe dry eye
✕. Subject with phthisis or phthisis suspect

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