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

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

Detailed Description
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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®

Official Title
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Prospective, Feasibility Study to Evaluate the Safety of the EndoArt™ for Treatment of Subjects Suffering From Corneal Edema

Conditions
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Chronic Cornel Edema

Intervention / Treatment
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* Device: EndoArt® Artificial Endothelial Layer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EndoArt®<br>EndoArt® Artificial Endothelial Layer | Device: EndoArt® Artificial Endothelial Layer<br>* device is intended for use as an endothelial kearatoprosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related adverse events | frequency and severity of all treatment-related adverse events | 6 months following EndoArt implantaion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective corneal clarity | corneal clarity will be graded by the investigator. Scoring is as follow: 0- clear 1-iris details can be seen 2- iris details are obscure 3- can hardly see the pupil 4- pupil or iris details ca not be seen | 12 months following EndoArt implantaion | 
| Pain as assessed by a Visual Analogue Scale (VAS) | VAS is a horizontal line, 100 mm in length, anchored by word descriptors at each end. The subject marks on the line the point that he feels represents his perception of his current state. | 12 months following EndoArt implantaion | 
| Measurement Best Corrected Distance Visual Acuity (BCDVA) | Visual acuity on the distance chart with best manifest correction for that distance | 12 months following EndoArt implantaion | 
| Corneal thickness | Corneal thickness will be measured by anterior segment Optical Coherence Tomography (OCT). | 12 months following EndoArt implantaion |