Health TrialsbyHealthPanel

EndoArt® Implantation in Subjects With Chronic Corneal Edema - US Study

ConditionCorneal Edema
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-85
SponsorEye-yon Medical

About this trial

The EndoArt® device is intended to treat patients with chronic corneal edema due to endothelial dysfunction, in whom prior multiple keratoplasty (EK/PK) have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty.

The EndoArt® (Corneal Artificial Endothelial layer) is a permanent synthetic implant. It is made of a clear, transparent, foldable, biologically compatible hydrophilic copolymer. The device serves as an inert physical barrier, blocking the ingress of fluid from the Anterior Chamber (AC) into the cornea.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female subjects 30-85 years of age.

Have chronic corneal edema (lasting at least 3 months) and have experienced at least 3 prior keratoplasty (EK/PK) failures.

Is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.

CCT of 650-1200 μm, not including DSAEK thickness.

Disqualifiers

No light perception or light perception.

Opaque scar in the visual axis that is indicated for PKP.

Irregular posterior cornea (e.g. post trauma) in the 6.5 mm central part of the cornea (EndoArt® diameter).

Current infection of the cornea.

Trial design

Design model

Single group

Treatments tested in this trial

  • The EndoArt® (Corneal Artificial Endothelial layer)

    Device

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

Treatment groups

123 Participants
are divided into 1 treatment group
Group A: EndoArt® Artificial Endothelial LayerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The rate of any device related SAE

SAEs may include, but are not limited to, e.g., secondary surgical intervention, severe infectious keratitis requiring hospitalization, and corneal perforation

Time frame
12 months
2

Improvement in visual acuity as measured by BCVA

The proportion of subjects achieving a change in visual acuity of at least 0.20 LogMAR for subjects with baseline BCVA better than 1.30 LogMAR, or a visual acuity of 1.30 LogMAR or better at 12 months postoperatively for subjects with baseline BCVA of 1.30 LogMAR or worse

Time frame
12 months

Secondary outcomes

1

All AE rate

Rate of each AE

Time frame
12 months
2

BCVA Success rate

BCVA Success rate of bad Vision Population (Baseline BCVA ≥ 1.30 LogMAR)

Time frame
12 months
3

CCT

Change in central corneal thickness as measured by OCT from baseline to 12 months

Time frame
12 months
4

Change in manifest refraction

The change in manifest refraction

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eye-yon Medical

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: