EndoArt® Implantation in Subjects With Chronic Corneal Edema

NCT05139771 | Completed

• 1 other identifier: CLI-E033
• Study Type: interventional
• Target: 52
• Locations: 6 countries
• Sites: 12

Brief 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).

Conditions

Corneal Edema

Keywords

Corneal edema; Chronic corneal edema; THE ENDOART®; Artificial Endothelial layer

Outcome Measures

Primary Outcomes (2)

• The frequency of device related adverse events (safety)

  Adverse events will be assessed on a continuous basis from baseline until follow-ups completion.

  12 months

• The severity of device related adverse events (safety).

  Adverse events will be assessed on a continuous basis from baseline until follow-ups completion.

  12 months

Secondary Outcomes (5)

• Change from baseline in central corneal thickness (CCT) postoperatively.

  6 months

• Incidence of primary post-surgical detachment of the device.

  12 months

• Rate of rebubbling post-op.

  12 months

• Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline.

  12 months

• Change in ocular pain score as assessed by a Visual Analogue Scale (VAS) from baseline.

  12 months

Study Arms (1)

EndoArt® Artificial Endothelial Layer

OTHER

EndoArt® is intended to be used as an endothelial prosthesis in patients with chronic corneal edema. One arm - all subjects will be implanted with EndoArt®.

Device: THE ENDOART® IMPLANTATION (Artificial Endothelial layer)

Interventions

THE ENDOART® IMPLANTATION (Artificial Endothelial layer) DEVICE

Implantation of EndoArt® is similar to other anterior segment surgical procedures such as DSAEK/DMEK.

Also known as: DSAEK, DMEK

EndoArt® Artificial Endothelial Layer

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 ≥ 1500).
• 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 day.
• Phthisis bulbi or subject is at risk of developing phthisis.
• 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

Sponsors & Collaborators

• Eye-yon Medical: lead

Study Sites (12)

Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)

Brest, 29200, France

Location

Hôpital Fondation A. de Rothschild

Paris, France

Location

Akhali Mzera Eye Clinic

Tbilisi, Georgia

Location

Caucasus Medical Center (CMC)

Tbilisi, Georgia

Location

Davinci Eye Medical Center

Tbilisi, Georgia

Location

High Technology Medical Center, University Clinic

Tbilisi, Georgia

Location

International Vision Correction Research Centre (IVCRC) Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Dr Agarwal's Eye Hospital

Tirunelveli, Tamil Nadu, 627003, India

Location

L V Prasad Eye Institute

Hyderabad, Telangana, 500034, India

Location

Rambam Medical Center

Haifa, Israel

Location

Assuta HaShalom

Tel Aviv, Israel

Location

Amsterdam MC (AMC)

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Corneal Edema

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: December 1, 2021
• Study Start: September 30, 2021
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: August 28, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GE (4); FR (2); NL (1); DE (1); IN (2); IL (2)