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

EyeYon Medical

Status

Completed

Conditions

Chronic Cornel Edema

Treatments

Device: EndoArt® Artificial Endothelial Layer

Study type

Interventional

Funder types

Industry

Identifiers

NCT03069521

ECL00041

Details and patient eligibility

About

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

Full description

Title: Prospective, feasibility study to evaluate the safety of the EndoArt® for treatment of subjects suffering from corneal edema

Device: EndoArt® (Artificial Endothelial Layer)

Intended Use: The EndoArt® device is intended for use as an endothelial kearatoprosthesis in patients with chronic cornel edema

Study Design: Prospective open-label feasibility clinical study

Study Objectives: To evaluate the safety of the EndoArt® implanted in subjects suffering from corneal edema.

Study Hypothesis: Treatment with the EndoArt® is safe and may result in alleviating symptoms resulting from chronic corneal edema (corneal thickness).

Study population: Men and women suffering from a decrease in vision due to chronic corneal edema that meet the inclusion/exclusion criteria and provide written Informed Consent will enrolled in the study.

Enrollment: A total of up to 30 subjects will be enrolled.

Study Duration: Completion of active enrollment is anticipated to last approximately 18 months. The primary end point will be achieved when the final study subject has completed 6 month follow up. Subject will be followed up to 12 month.

Primary Safety Endpoint: The frequency and severity of all treatment-related adverse events, during and after implantation of the EndoArt® and throughout the 6 month follow-up period. Adverse events will be assessed on a continuous basis from the procedure through the study completion at 6 months. Related adverse events include: corneal perforation, melting, uncontrolled inflammation, severe infection.

Secondary Efficacy Endpoints: Corneal thickness, Subjective corneal clarity, Pain as assessed by a Visual Analogue Scale (VAS) Measurement Best Corrected Distance Visual Acuity (BCDVA)

Study Treatment: Subjects will be implanted with the EndoArt®

Enrollment

22 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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
Subject with low ocular pressure ≤6 mmHg or higher than 25 mmHg.
Subject with aphakica
Subject with pseudophakodonesis
Subject with large iris defect which can compromise intraoperative AC stability.
Subjects after corneal refractive surgery.
Subject with glaucoma shunt (e.g. Ahmend valve)
Subject with neurotrophic corneal history
Subject with history of persistent corneal erosion difficulties with epithelial growth (re-epithelization)
Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days