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

Chronic Cornel Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069521
• Other study ID #: ECL00041
• Status: Completed
• Phase: N/A
• Start date: June 22, 2017
• Est. completion date: January 30, 2023

Study information

• Verified date: February 2023
• Source: Eye-yon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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®

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Cornel Edema
• Corneal Edema
• Edema

Intervention

Device:
• EndoArt® Artificial Endothelial Layer
device is intended for use as an endothelial kearatoprosthesis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eye-yon Medical

Countries where clinical trial is conducted

Germany,  Israel,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-related adverse events	frequency and severity of all treatment-related adverse events	6 months following EndoArt implantaion
Secondary	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
Secondary	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
Secondary	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
Secondary	Corneal thickness	Corneal thickness will be measured by anterior segment Optical Coherence Tomography (OCT).	12 months following EndoArt implantaion