Prospective, Investigator-Initiated Study To Evaluate The Safety And Indicative Effectiveness Of Xenia™ Custom-Made Ocular Implant In Subjects Having Keratoconus.

To evaluate the safety and efficacy of Xenia custom-made implants in the treatment of advanced keratoconus.

IRB and CDSCO approved and CTRI registered (CTRI/2021/04/033197) clinical trial conducted at LV Prasad Eye Institute, Hyderabad, India, a tertiary care referral eye institute in South India

 7 eyes of 7 subjects (5 male and 2 female) diagnosed with advanced keratoconus were included. All patients were contact lens intolerant in the eye for surgery and had the best-corrected visual acuity (BCVA) of at least 20/40 in the other eye. The Xenia lenticule was inserted into a lamellar pocket created with the femtosecond laser at a depth of between 120 and 140 microns.

The BCVA improved from 0.89±0.13logMAR to 0.45±0.03logMAR. The mean corneal thickness(CT) increased from 354.71±9.30µm to 382.67±29.02µm, and the mean keratometry readings decreased from 68.09±4.41D to 43.80±4.04D. Statistically significant improvement was noticed in pre- and post-operative BCVA, CT, and K-readings. The Xenia lenticule was extracted for three individuals; two had an adverse event of a non-resolving epithelial defect, and the other was lost to follow-up. The stability of Xenia lenticule was maintained throughout the 1 year follow-up period.

Implantation of the Xenia lenticule in patients with advanced keratoconus provides an alternative to corneal transplantation and results in a significant improvement in visual acuity and a reduction of the corneal curvature and refractive power over a year of follow-up.