Safety and Indicative Effectiveness of Porcine Corneal Lenticular Implants in Patients with Advanced Keratoconus and Post Lasik Ectasia: A Retrospective Clinical Study

• Published in: Clinical ophthalmology (Auckland, N.Z.) N.Z.), 2021-01, Vol.15, p.3165-3171
• Main Authors: Massry, Ahmed El, Ibrahim, Osama, Abdalla, Moones, Osman, Ihab, Mahmoud, Shahira
• Format: Article
• Language: English
• Subjects: Care and treatment; Clinical trials; Contact lenses; Cornea; Disease; ectasia; femtosecond; Keratoconus; keratoplasty; Lasers; Original Research; Patients; Safety and security measures; Tomography; Transplants & implants
• ISSN: 1177-5483; 1177-5467; 1177-5483
• DOI: 10.2147/OPTH.S325666

Purpose: This study aimed to evaluate the safety and feasibility of implanting decellularized porcine comeal 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 [+ or -] 45.41 to 429.33[+ or -] 63.20 gm, the maximum keratometry decreased from 64.8 [+ or -]5.11 to 62.82[+ or -] 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. Keywords: keratoconus, keratoplasty, femtosecond, ectasia