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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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

Detailed Summary:

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 12 subjects will be enrolled.

Study Duration: Completion of active enrolment is anticipated to last approximately 12 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 pe
Sponsor: Eye-yon Medical

Current Primary Outcome: Treatment-related adverse events [ Time Frame: 6 months following EndoArt implantaion ]

frequency and severity of all treatment-related adverse events


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Subjective corneal clarity [ Time Frame: 12 months following EndoArt implantaion ]

    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
  • Pain as assessed by a Visual Analogue Scale (VAS) [ Time Frame: 12 months following EndoArt implantaion ]

    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.

  • • Measurement Best Corrected Distance Visual Acuity (BCDVA) [ Time Frame: 12 months following EndoArt implantaion ]
    Visual acuity on the distance chart with best manifest correction for that distance


Original Secondary Outcome: Same as current

Information By: Eye-yon Medical

Dates:
Date Received: February 19, 2017
Date Started: March 2017
Date Completion: November 2018
Last Updated: February 27, 2017
Last Verified: February 2017