EndoArt® Implantation in Subjects With Chronic Corneal Edema (NCT05139771) | Clinical Trial Compass
CompletedNot Applicable
EndoArt® Implantation in Subjects With Chronic Corneal Edema
France, Georgia52 participantsStarted 2021-09-30
Plain-language 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).
Who can participate
Age range40 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. History of ocular Herpetic keratitis.
✕
What they're measuring
1
The frequency of device related adverse events (safety)
Timeframe: 12 months
2
The severity of device related adverse events (safety).