Abstract
Corneal inlays are a relatively new treatment option for presbyopia. Using biological inlays, derived from lenticules extracted from small incision lenticule extraction, may offer advantages over commercialized synthetic inlays in the aspect of biocompatibility. We conducted a non-human primate study to evaluate the safety, predictability, efficacy and tissue response after autogeneic, decellularized xenogeneic and xenogeneic lenticule implantation. The lenticule implantation effectively resulted in central corneal steepening (simulated keratometric values increased by 1.8–2.3 diopters), central hyper-prolate changes (asphericity Q values changed by −0.26 to −0.36), corneal anterior surface elevation (7.7–9.3 μm) and reasonable effective zone (1.5–1.8 times of the lenticule physical diameter), with no differences among the three groups. Slit lamp microscopy, transmission electron microscopy, confocal microscopy, histology and immunohistochemistry analyses confirmed the biocompatibility of the autogeneic and decellularized lenticules, whereas one eye in the xenogeneic group developed corneal stromal rejection during the study period. Our results showed that lenticule implantation has the potential for the management of presbyopia, and provide the basis for future clinical studies. The decellularization process may increase the potential utilization of lenticules without changing the efficacy.
Highlights
Presbyopia affects individuals older than 40 years and is the most common refractive error[1]
We demonstrated that implanting a lenticule derived from Small incision lenticule extraction (SMILE) has the potential for the management of presbyopia
It effectively resulted in corneal central steepening, central hyper-prolate changes, reasonable corneal anterior surface elevation and effective zone, and acceptable predictability with no differences in the autogeneic and decellularized xenogeneic groups
Summary
Presbyopia affects individuals older than 40 years and is the most common refractive error[1]. Small incision lenticule extraction (SMILE) is a small-incision, femtosecond laser refractive lenticule extraction (ReLEx) procedure It has become clinically available in Europe and Asia as an alternative to laser-assisted in situ keratomileusis (LASIK) for the correction of myopia and myopic astigmatism since 2012, and was approved www.nature.com/scientificreports/. It has been described to be used as a corneal patch graft for the management of corneal micro-perforation or partial-thickness corneal defect[11], and for the treatment of keratoconus or hyperopia, by transplanting the lenticule into stroma[12,13,14,15] No postoperative complications, such as allogeneic rejection or corneal haze, were reported in these studies[11,12,13,14,15], the sample size was small. The use of decellularized biological inlays may offer advantages over synthetic inlays in the aspect of biocompatibility
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