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
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
Treatments tested in this trial
- The EndoArt® (Corneal Artificial Endothelial layer)
Treatment groups
123 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov