EndoArt® Implantation in Subjects With Chronic Corneal Edema

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    80
  • sponsor
    Eye-yon Medical
Updated on 23 May 2022

Summary

The EndoArt® is intended to be used as an endothelial prosthesis in patients with chronic corneal edema.The EndoArt® (Artificial Endothelial layer) is a permanent implant, constructed of a clear, transparent, foldable, biologically compatible copolymer of hydroxyethyl methacrylate and methyl methacrylate. The peripheral surface of the EndoArt® has either one or more marks, to ensure the correct orientation of the implant. The device serves as a physical barrier blocking the influx of water from the AC of the eye into the cornea due to dysfunctional corneal endothelial layer. Together with evaporation from the anterior surface of the cornea it maintains corneal hydration and clarity.

The EndoArt® device is CE marked approved (approved for marketing by the European regulatory authority).

Description

This study is a prospective, multicenter, open-label, phase 2 clinical investigation assessing safety of EndoArt® implantation, in subjects with chronic corneal edema. Safety will be assessed by evaluating the rate of adverse events and adverse device effects throughout the study period. Exploratory efficacy endpoints will be assessed by measuring the change in corneal thickness from baseline, change in pain score from baseline and changes in visual acuity. Time to, and rate of, post-surgical rebubbling to facilitate adhesion of the device will be explored.

Subjects with chronic corneal edema that meet the inclusion/exclusion criteria will be the study target population. The study will encompass a total of up to 80 subjects who will complete the Protocol follow-up schedule. For the Primary endpoint, the frequency and severity of device related adverse events, from patient entry through the 6-month follow-up period will be analyzed. Adverse events will be assessed on a continuous basis and will continue to be collected for 12 months.

This clinical investigation is conducted in up to 12 (twelve) clinical sites in Europe (Germany, France, and Netherlands), Mexico, India and Israel. Additional sites may be considered.

This clinical investigation has been designed to provide continuous clinical evidence for the EndoArt® as part of its clinical follow up program.

Details
Condition Corneal Edema
Treatment THE ENDOART® IMPLANTATION (Artificial Endothelial layer)
Clinical Study IdentifierNCT05139771
SponsorEye-yon Medical
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Individuals must meet the following inclusion criteria at screening visit
Male or Female subjects 40-85 years of age
Have chronic corneal edema (for a minimum of 3 months) secondary to endothelial dysfunction
Have corneal thickness >600μm by OCT
Have best corrected distance visual acuity 6/19 (20/63) or worse (equivalent ETDRS= 60 letters) with subjective symptoms of impaired visual function
Subject with posterior pseudophakia and stable IOL
Willing and able to understand and sign informed consent prior to any study related procedure
Willing and able to follow study instructions (e.g., to lay on one's back for 4 hours post op), able to self-administer or have caregiver available to administer eyedrops as required by the protocol for the duration of the study, and able to attend study visits/assessments for the duration of the study

Exclusion Criteria

Individuals for participation will be ineligible for the study if any of the following
conditions apply
History of ocular Herpetic keratitis
Scarred cornea resulting in visual impairment with intact endothelium (cell density ≥
History of posterior vitrectomy
)
Post PKP
Have an irregular posterior cornea (e.g., post trauma)
Have a current infection of the cornea
Have band keratopathy and/or limbal stem cell deficiency
Have clinically severe dry eye disease which needs more than 4 drops of lubricant per
Phthisis bulbi or subject is at risk of developing phthisis
day
Subject with medically uncontrolled high intra ocular pressure
Aphakia
Anterior chamber IOL or fixated anterior chamber IOL
Pseudophakodonesis
Have large iris defect which could compromise intraoperative air bubble formation
Have undergone corneal refractive surgery
History of neurotrophic cornea
History of recurrent corneal erosion or persistent epithelial defect
Recurrent posterior, intermediate or anterior uveitis
Subject receiving regular intravitreal injection
IridoCorneal Endothelial (ICE) Syndrome or any rare disease/ syndrome creating
anatomical or physiological anomalies of the anterior chamber (e.g., corectopia)
Currently participating or have participated in an investigational study, other than
this study, within the past 60 days
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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