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Long term safety of artificial corneal lenticular implants in patients with advanced keratoconus and post LASIK ectasia

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First Author: A.Elmassry EGYPT

Co Author(s):    S. Rashad   M. Abdalla                 

Abstract Details

Purpose:

Purpose : To evaluate the safety and efficacy of implanting decellularized artificial Corneal lenticular implants in a femtosecond laser-assisted pocket for patients with advanced keratoconus and post-Lasik Ectasia.

Setting:

A prospective, non- randomised , non-comparative, interventional case series that was performed in Roayah vision center in Alexandria Egypt from June 2019 and followed up till September 2020

Methods:



Methods:

A prospective, non-randomized, non-comparative, interventional case series of implanting a corneal lenticular implant in seven eyes; six with advanced Keratoconus and clear cornea and one with advanced post Lasik ectasia with follow up for 15 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 then the artificial corneal lenticule (XENIA IMPLANT) was implanted inside the pocket followed by corneal cross-linking 3 months later for six out of seven eyes.

Results:

Mean age was 27.67±9 years. one eye had wrinkles and opacified graft, and it was exchanged 3 months postoperatively. Six eyes showed improvement in visual acuity at 1, 6 ,12 & 15 months with statistically significant (P=0.002 and 0.007). At 15months follow up; the mean central corneal thickness (CCT) 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 mmHg, the total higher-order aberrations decreased from 1.80 to 1.16 mmHG that was statistically significant. All grafts showed no haze.

Conclusions:



Conclusions:

The implantation of Artificial Corneal Lenticules followed by Corneal Cross-linking results in improvement of visual acuity, increase in corneal resistance and, an increase in central corneal thickness. It may be a safe and effective way to avoid Corneal transplantation (DALK) in patients with advanced Keratoconus with clear cornea. After 15 months of Implantation ; there is no immunological reaction of the implant in human eyes

Financial Disclosure: