Preliminary Evidence of Successful Near Vision Enhancement With a New Technique: PrEsbyopic Allogenic Refractive Lenticule (PEARL) Corneal Inlay Using a SMILE Lenticule

PURPOSE: To describe a new technique (PrEsbyopic Allogenic Refractive Lenticule [PEARL] inlay) using an allogenic corneal inlay prepared from a small incision lenticule extraction (SMILE) lenticule. METHODS: A SMILE lenticule of specified thickness (mean: 61.5 +/- 3.32 mu m) was trephined at the center to 1-mm diameter and implanted in the cornea on the coaxially sighted light reflex under a femtosecond laser-created cap of 120 mu m in the nondominant eye of presbyopic patients. RESULTS: Four emmetropic presbyopic patients underwent PEARL inlay implantation in the nondominant eye. In the operated eye, uncorrected near visual acuity at 33 cm improved from J8 to J2 in one and from J5, J6, and J7, respectively, to J2 in three operated eyes with improvement between three and five lines in all eyes. Uncorrected intermediate visual acuity ranged between J3 and J5 at 67 cm and uncorrected distance visual acuity remained 20/20 in the operated eye and binocularly. The patients were comfortable and reported independence from glasses for near, intermediate, and distance for all of their routine visual tasks for the 6-month follow-up period. There were no complaints of dysphotopsia or troublesome night glare/halos. All lenticules remained well centered during the follow-up and no lenticule-induced complications were seen. All patients reported satisfaction with the surgical procedure. Topography showed a central area of prolateness corresponding to the PEARL inlay. The inlay was not visible on naked eye examination. CONCLUSIONS: This preliminary study demonstrates the safety and efficacy of a PEARL corneal inlay for presbyopic correction. Further studies are recommended to determine long-term outcomes.