SAFETY AND EFFICACY OF ENDOTHELIAL TISSUE SUBSTITUTES: RESULTS AT 3-YEAR FOLLOW-UP FROM INDIA

To assess the long-term safety and effectiveness of implanting a synthetic endothelial keratoprosthesis in cases with pseudophakic chronic endothelial dysfunction.

A prospective open-label clinical safety & efficacy evaluation (INDIA Study).

Endothelial dysfunction following pseudophakic corneal edema, which is not associated with systemic diseases like Herpes Simplex or prior corneal surgeries was subjected to a central 6.5 mm synthetic endothelial implantable substitute after a central 7.0mm descemetorhexis & attached with C3F8 gas (85% fill in the AC). Pre & post-operative central pachymetry (in mic.), vision (in ETDRS characters), and pain analog (1-100) were analyzed in addition to re-bubbling rates & toxic reactions due to implants, and followed up by the end of 3 years.

12 cases were enrolled, 2 subjects died, 9 completed FU by 36M. The longest FU is 48M, min. is 39M. Baseline vision was 10.54+/-2.2 ETDRS characters, which improved to 41.75+/-8.7 by M-1 & retained VA gains by 46.72+/-13.1 characters after M-36. Mean Central pachymetry reduced from 720 mic, to 552 mic. by M-1 & maintained at 491 mic. by M-12, and 521 microns by M-36. The presenting pain was 91.9+/-2.3 & was 7.7+/-2.5 at M-12 and 6.5+/- 2.1 by M-36 (all p<0.0001). No immunologic or other adverse reactions were noticed. None were explanted. 4 cases needed re-bubbling in early periods (D7, D7, D12 & 21,D7, D14&M3). 1 subject developed severe surface scarring after M-18.

Endothelial keratoprosthesis improved vision, reduced edema caused by pseudophakic endothelial dysfunctions & was not associated with toxicities until M-36, & is continuously monitored. It could be an alternative to EK with no risks of rejection or graft failures when tissue availability is challenging or the risk of rejection is greater.