Outcomes of Synthetic Corneal Endothelial Implant in Patients with Corneal Oedema with or without Prior Endothelial Keratoplasty: A Case Series.

PURPOSE: To evaluate the safety and efficacy of artificial endothelial layer (EndoArt®) implantation in patients with chronic corneal edema with or without prior endothelial keratoplasty at a tertiary referral center.

METHODS

This retrospective, non-comparative study reviewed medical records of consecutive patients who underwent EndoArt® (EyeYon Medical, Israel) implantation between December 2024 and November 2025. Patients with chronic corneal oedema and a minimum 12-week follow-up were included; eyes with prior penetrating keratoplasty were excluded. Primary outcome was central corneal thickness (CCT) measured by anterior segment optical coherence tomography. Secondary outcomes included best-corrected distance visual acuity (BCDVA), intraocular pressure, resuturing/rebubbling rates, and complications.

RESULTS

Nine eyes of nine patients were included (mean age: 72±17 years; 55% female). Four patients (44%) had previous failed endothelial keratoplasty. Mean follow-up was 27±14 weeks. Mean baseline CCT decreased significantly from 780±106μm [95% CI: 710.0, 861.3μm] to 574±107μm [95% CI 502.8, 643.1μm], postoperatively (adjusted for implant thickness), representing a 35% reduction (265±89 μm; 95% CI: -338.8 to -190.8μm; p<0.01). Mean BCDVA improved from 2.28±0.54 LogMAR [95% CI 1.87, 2.71 LogMAR] to 1.16±0.79 LogMAR [95% CI 0.55, 1.78 LogMAR]. Three patients (33%) achieved postoperative BCDVA of ≤0.5 LogMAR. Two patients (22%) required re-suturing; no rebubbling was performed. No endophthalmitis, inflammatory reactions, or chronic intraocular pressure elevation occurred.

CONCLUSION

Artificial corneal endothelial implant was associated with significant reduction in corneal thickness (35%) and improvements in visual acuity in eyes with chronic endothelial dysfunction, with or without prior endothelial keratoplasty. The procedure was feasible in complex eyes with prior failed endothelial keratoplasty and glaucoma drainage devices. EndoArt® represents a viable donor-tissue-independent alternative for high-risk patients in whom traditional keratoplasty carries a guarded prognosis.