Abstract

Purpose:To evaluate safety & effectiveness of novel endothelial keratoprosthesis in cases with chronic endothelial dysfunction.
Methods: Phase-2 safety & efficacy evaluation. Endothelial dysfunction not associated with Herpes or prior corneal surgeries was subjected to central 6mm synthetic endothelial implantable substitute (SES) after 7.0mm descemetorhexis & attached with gas. Pre & post-op pachymetry(mic.), vision (ETDRS characters), pain (1-100)were analyzed in addition to re-bubbling rates & toxic reactions.
Results:12 cases enrolled. Longest follow-up-16 months, Baseline vision was 10.54+/-2.2, which improved to 41.75+/-8.7 by M-1 & 60.72+/-13.1 by M-12. CCT reduced from 720 mic to 552 by M-1 & maintained at 491 by M-12. Presenting pain was 91.9+/-2.3 & 7.7+/-2.5 at M-12 (p=0.0001). No adverse reactions noticed. None explanted. 4 needed re-bubbling (D7, D7, D12 & 21,D7,D14&M3).
Conclusion: SES improved vision, reduced edema & was not associated with toxicities until M-12.