A Phase-2 Study On Novel Endothelial Keratoprosthesis In Chronic Endothelial Dysfunction: Interim Trial Reports

 To evaluate the safety and effectiveness of implanting a novel synthetic corneal endothelial substitute (endothelial keratoprosthesis) in cases with chronic endothelial dysfunction. 

 A phase-2 prospective open-label clinical safety & efficacy evaluation.

Cases of chronic corneal edema due to endothelial dysfunction following pseudophakic corneal edema and FECD, not associated with systemic diseases like Herpes Simplex or prior corneal surgeries were subjected to a central 6 mm synthetic endothelial implantable substitute after a central 7.0mm descemetorhexis & attached similar to endothelial keratoplasty and with C3F8 gas (85% fill in the AC). Pre & post-operative central pachymetry (in mic.), vision (in ETDRS characters), and pain & discomfort scores (ranging from 1-100) were analyzed in addition to re-bubbling rates & toxic reactions due to implants or any adverse events. The follow-up would be continued until 24 months.

12 cases were enrolled. The longest follow-up is 10 months and the lowest is 6 months. Vision at baseline was 9.75+/-1.7 ETDRS characters, which improved to 41.75+/-8.7 by Month-1 and retained after 6-Mon. at 55.59+/-7.1. Mean Central pachymetry reduced from 715 mic, to 504 by Month-1 & maintained at 492.5 by Month-6. Pain at presentation was 90.5+/-2.3 & 68.25+/-4.03 at 1- Mon, further reduced by Mon-6 (p=0.0001). No immunologic reactions to the implants or other adverse reactions were noticed. None were explanted. 3 cases needed re-bubbling (D7, D7, D12 & 21). For one subject who died after 6 months, post-mortem HPE reports revealed epithelialization & fibrosis along the implant edges to the cornea, favoring long-term device retention. 

Endothelial keratoprosthesis improved vision, reduced chronic edema caused by endothelial dysfunction & was not associated with adverse events or implant toxicities until month-6, & are continuously been monitored for safety.

Endothelial keratoprosthesis could be an alternative to EK procedures with no risks of associated rejection events or primary graft failures, could change the practice pattern of "Transplant to Implant Science" can be performed by any anterior segment surgeons, and reduce the backlog of transplant waiting lists.