A Foldable Nonpenetrating Keratoprosthesis: Medium to Long-Term Clinical Results in Patients with Corneal Blindness due to Noninflammatory Anterior Cornea Disease.

PURPOSE

To report the medium to long-term safety and performance outcomes of the KeraKlear nonpenetrating artificial cornea (KeraKlear) as the primary procedure in patients with corneal blindness due to noninflammatory anterior cornea disease.

METHODS

Fifteen patients with corneal blindness (preoperative visual acuity [VA] of ≥20/200) due to a non-inflammatory anterior corneal condition were included in this prospective, single-center study. Preoperative diagnoses included corneal scars, keratoconus, and corneal dystrophies. Diseased corneas were implanted with the KeraKlear (KeraMed Inc., Irvine, California, USA) by a single surgeon (JMV) using a femtosecond laser to create all incisions. Participants were followed up with for as long as 64 months. Uncorrected Snellen VA and postoperative complications were recorded.

RESULTS

The average age at the time of surgery was 49.6 years old and 67% of patients were female. The patients experienced an average improvement in uncorrected Snellen VA of 7.6 lines (-1.17 logMAR). Average uncorrected vision at the last visit was 20/100 (0.73 logMAR), and median uncorrected vision at the last visit was 20/70 (0.54 logMAR). One patient experienced extrusion of the KeraKlear due to infection. There were no cases of glaucoma, retroprosthetic membrane, or endophthalmitis, the three most common complications of penetrating keratoprostheses (KPro).

CONCLUSIONS

Medium and long-term outcomes of the KeraKlear indicate that this device is a viable alternative to corneal transplantation as a primary procedure in patients with non-inflammatory causes of corneal blindness, especially when corneal tissue is not available. The KeraKlear does not penetrate into the anterior chamber, and therefore, is less susceptible to the most common complications of penetrating KPro including endophthalmitis, glaucoma, and retroprosthetic membrane. The KeraKlear also has a comparable or improved adverse event rate compared to penetrating keratoplasty.