Safety and indicative effectiveness of porcine corneal lenticular implants in patients with advanced Keratoconus and post Lasik Ectasia: A retrospective clinical study

Abstract

Purpose: This study aimed to evaluate the safety and feasibility of implanting decellularized porcine corneal lenticules in a femtosecond laser-assisted pocket for patients with advanced keratoconus and post-Lasik ectasia. Methods: This is a retrospective clinical study of implanting a porcine corneal lenticular implant in seven eyes: Six with advanced keratoconus and clear cornea and one with advanced post-Lasik ectasia with a follow-up for 12 months. The lenticules are extracted from porcine tissue, subjected to a decellularization process, intensely cross-linked, sterilized and packed. They are 7 mm in diameter with at 100-120-micron thickness. The femtosecond laser was used to create an intra-stromal pocket, and then the lenticules were implanted inside the pocket followed by corneal cross-linking 3 months later for six out of seven eyes. Results: Five patients had keratoconus (6 eyes) and one patient (one eye) had post-Lasik ectasia. Visual acuity improved in all patients except for one case at 6 and 12 months and this was statistically significant (P=0.002 and 0.007). At one-year follow-up, the mean central corneal thickness increased from 389.43 ± 45.41 to 429.33± 63.20 µm, the maximum keratometry decreased from 64.8 ±5.11 to 62.82± 6.16 D, the mean corneal resistance factor (CRT) increased from 5.67 to 8.42, and the total higher-order aberrations decreased from 1.80 to 1.16. Both changes in the CCT and CRF were statistically significant. One eye had wrinkles and opacified graft, and it was exchanged 3 months postoperatively. Conclusion: Porcine corneal lenticules implantation is immunologically safe and well tolerated in patients with advanced keratoconus and post-Lasik ectasia and may be feasible as an alternative to keratoplasty.