NCT03069521

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

June 22, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

5.6 years

First QC Date

February 19, 2017

Last Update Submit

February 15, 2023

Conditions

Chronic Cornel Edema

Outcome Measures

Primary Outcomes (1)

  • Treatment-related adverse events

    frequency and severity of all treatment-related adverse events

    6 months following EndoArt implantaion

Secondary Outcomes (4)

  • Subjective corneal clarity

    12 months following EndoArt implantaion

  • Pain as assessed by a Visual Analogue Scale (VAS)

    12 months following EndoArt implantaion

  • Measurement Best Corrected Distance Visual Acuity (BCDVA)

    12 months following EndoArt implantaion

  • Corneal thickness

    12 months following EndoArt implantaion

Study Arms (1)

EndoArt®

OTHER

EndoArt® Artificial Endothelial Layer

Device: EndoArt® Artificial Endothelial Layer

Interventions

EndoArt® Artificial Endothelial LayerDEVICE

device is intended for use as an endothelial kearatoprosthesis

EndoArt®

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is over 40 years old
  • Subject with chronic corneal edema.
  • Subject with corneal thickness \>650 µm
  • Subject with visual acuity 6/30 or worse (equivalent ETDRS)
  • Subject with better visual acuity in the contralateral eye.
  • Pseudophakic subject (anterior or posterior) with stable IOL.
  • Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.

You may not qualify if:

  • Subject with best corrected visual acuity of 6/30 or worse in the fellow eye
  • Subject with history of ocular Herpes keratitis
  • Subject with severely scarred cornea (unfit for regular endothelial keratoplasty)
  • Subject with irregular posterior cornea (e.g. post PKP)
  • Subject who is suffering from infection of the cornea
  • Patients with band keratopathy and/or limbal stem cell deficiency.
  • Subject with clinical moderate to severe dry eye
  • Subject with phthisis or phthisis suspect
  • Subject with low ocular pressure ≤6 mmHg or higher than 25 mmHg.
  • Subject with aphakica
  • Subject with pseudophakodonesis
  • Subject with large iris defect which can compromise intraoperative AC stability.
  • Subjects after corneal refractive surgery.
  • Subject with glaucoma shunt (e.g. Ahmend valve)
  • Subject with neurotrophic corneal history
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

International Vision Correction Research Centre (IVCRC) Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Barzilai MC

Ashkelon, Israel

Location

Soroka Medical Center

Beersheba, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Assuta Medical Center

Tel Aviv, Israel

Location

Tel Aviv Souraski Medical Center

Tel Aviv, Israel

Location

AMC

Amsterdam, Netherlands

Location

IMO - Institut de Microcirurgia Ocular

Barcelona, Spain

Location

Study Design

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

Study Record Dates

First Submitted

February 19, 2017

First Posted

March 3, 2017

Study Start

June 22, 2017

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

February 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)NL(1)ES(1)IL(5)