Transplant To Implant Science: Longitudinal Analysis Of Endothelial Tissue Substitutes

To evaluate the safety and effectiveness of implanting a novel synthetic corneal endothelial substitute(endothelial keratoprosthesis) in cases with pseudophakic chronic endothelial dysfunction, and its long-term safety.

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

A prospective open-label clinical safety & efficacy evaluation. 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 monthly.

12 cases were enrolled. The longest follow-up is 36 months, min. follow-up is 24 months. Baseline vision was 10.54+/-2.2 ETDRS characters, which improved to 41.75+/-8.7 characters by M-1 & retained at 56.72+/-13.1 characters by M-24. 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-24. The presenting pain was 91.9+/-2.3 & was 7.7+/-2.5 at M-12 (p<0.0001) and 6.5+/- 2.1 by M-24. 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). One subject died after 6 months, postmortem HPE reports revealed epithelialization & fibrosis along edges favoring long-term device retention.

Endothelial keratoprosthesis improved vision, and reduced edema caused by pseudophakic endothelial dysfunctions & was not associated with toxicities until month 24, & is continuously monitored. It could be an alternative to EK with no risks of rejections or graft failures, and could change the practice pattern of "Transplant to Implant Science". This could shorten the gap between needed corneal tissues and availability in the developing world.