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

February 15, 2023 updated by: Eye-yon Medical

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

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

Study Overview

Status

Completed

Detailed 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®

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Heidelberg, Germany
        • International Vision Correction Research Centre (IVCRC) Universitätsklinikum Heidelberg
      • Ashkelon, Israel
        • Barzilai MC
      • Be'er Sheva, Israel
        • Soroka Medical Center
      • Haifa, Israel
        • Rambam Medical Center
      • Tel Aviv, Israel
        • Assuta Medical Center
      • Tel Aviv, Israel
        • Tel Aviv Souraski Medical Center
      • Amsterdam, Netherlands
        • AMC
      • Barcelona, Spain
        • IMO - Institut de Microcirurgia Ocular

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is over 40 years old
  2. Subject with chronic corneal edema.
  3. Subject with corneal thickness >650 µm
  4. Subject with visual acuity 6/30 or worse (equivalent ETDRS)
  5. Subject with better visual acuity in the contralateral eye.
  6. Pseudophakic subject (anterior or posterior) with stable IOL.
  7. 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:

  1. Subject with best corrected visual acuity of 6/30 or worse in the fellow eye
  2. Subject with history of ocular Herpes keratitis
  3. Subject with severely scarred cornea (unfit for regular endothelial keratoplasty)
  4. Subject with irregular posterior cornea (e.g. post PKP)
  5. Subject who is suffering from infection of the cornea
  6. Patients with band keratopathy and/or limbal stem cell deficiency.
  7. Subject with clinical moderate to severe dry eye
  8. Subject with phthisis or phthisis suspect
  9. Subject with low ocular pressure ≤6 mmHg or higher than 25 mmHg.
  10. Subject with aphakica
  11. Subject with pseudophakodonesis
  12. Subject with large iris defect which can compromise intraoperative AC stability.
  13. Subjects after corneal refractive surgery.
  14. Subject with glaucoma shunt (e.g. Ahmend valve)
  15. Subject with neurotrophic corneal history
  16. Subject with history of persistent corneal erosion difficulties with epithelial growth (re-epithelization)
  17. Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EndoArt®
EndoArt® Artificial Endothelial Layer
device is intended for use as an endothelial kearatoprosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-related adverse events
Time Frame: 6 months following EndoArt implantaion
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
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
12 months following EndoArt implantaion
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.

12 months following EndoArt implantaion
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
12 months following EndoArt implantaion
Corneal thickness
Time Frame: 12 months following EndoArt implantaion
Corneal thickness will be measured by anterior segment Optical Coherence Tomography (OCT).
12 months following EndoArt implantaion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2017

Primary Completion (Actual)

January 30, 2023

Study Completion (Actual)

January 30, 2023

Study Registration Dates

First Submitted

February 19, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECL00041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Cornel Edema

Clinical Trials on EndoArt® Artificial Endothelial Layer

3
Subscribe