Novel New Disc Type Artificial Cornea ; Phase 3 Clinical Trial
Published 2025 - 43rd Congress of the ESCRS
Reference: PP06.18 | Type: Poster | DOI: 10.82333/ve0f-nq52
Authors: Hungwon Tchah* 1 , Hun Lee 2 , Ho Seok chung 3 , Jae Yong Kim 2
1ophthalmology,University of Ulsan,se,Korea, Republic Of, 2ophthalmology,Asan Medical Center,se,Korea, Republic Of;ophthalmology,University of Ulsan,se,Korea, Republic Of, 3ophthalmology,University of Ulsan,ssese,Korea, Republic Of;ophthalmology,Asan Medical Center,oulse,Korea, Republic Of
Purpose
To evaluate the efficacy and biocompatibility of a novel artificial cornea in a human clinical trial.
Setting
University setting Phase 3 Clinical tiral
Methods
The novel artificial cornea is a disc-shaped device composed of a new PMMA polymer central optic section (diameter 6 mm), which resembles the Alphacor shape, and a porous skirt (2 mm) designed to enhance cellular infiltration. A 300-degree corneal peritomy was performed, followed by the creation of a corneal flap. After the removal of the central posterior cornea (diameter 3 mm), the artificial cornea was inserted, and the flap was sutured back into its original position. The central visual axis was established using a trephine (diameter 2 mm) 4 weeks postoperatively. Outcomes, including slit-lamp examination, uncorrected visual acuity (UCVA), and tactile intraocular pressure (IOP), were evaluated.
Results
Artificial corneas were implanted in 9 patients. The average follow-up period was 5 months (range: 224 months). Suture release and conjunctival tissue adhesion were observed; however, the implants were maintained successfully in 8 out of 9 patients. One patient required removal of the artificial cornea due to corneal flap melting at 3 months postoperatively, despite an improvement in UCVA from hand motions (HM) to 0.1. In one patient, the artificial cornea was maintained for up to 24 months. Best-corrected visual acuity (BCVA) improved in all patients postoperatively, with UCVA improving from HM to at least 0.1. No infections or significant increases in tactile IOP were observed during follow-up.
Conclusions
The novel artificial cornea shows promise for human use and appears to be safe. However, further studies are necessary to confirm its long-term efficacy and safety.