Small aperture keratophakia for correction of presbyopia

Abstract

AbstractPurpose To assess the safety and efficacy of a small‐aperture optic device for the treatment of presbyopia in emmetropic presbyopes.Methods The Kamra Inlay, formerly known as the AcuFocus ACI corneal inlay (AcuFocus, Irvine, CA), is an ultrathin microperforated, opaque artificial aperture (3.8 mm outer diameter and 1.6 mm inner diameter) made of highly biocompatible polyvinylidene flouride (PVDF). A randomized pattern of minute holes allows nutritional flow through the implant to the anterior stroma. Following creation of a superior‐hinged flap in the non‐dominant eye, a Kamra inlay was centered on the stroma based on the first Purkinje reflex in 32 emmetropic patients with a mean age of 51.20 ± 2.2 years. Manifest refraction and visual acuity at three years postoperative are reported here. Four year data will be presented at the meeting.Results In the implanted eye, mean spherical equivalent shifted from 0.19 ± 0.22 D preop to 0.08 ± 0.68D at 3 years. Mean UNVA improved from J7/J8 to J1 at 3 years. Mean UIVA went from 20/40 preop to 20/25 at 3 years. Mean UDVA decreased slightly from 20/16 to 20/20 at 3 years. At 3 years, all eyes achieved UDVA of 20/32 or better. Mean binocular UDVA was 20/16. There were no explants. Two inlays had to be recentered due to initial misplacement. During the follow up period, no irritation, inflammatory reactions, or changes in corneal appearance were observed.Conclusion The Kamra corneal inlay improves near and intermediate vision without severe loss of distance visual acuity in emmetropic presbyopes by increasing the depth of field, based on the small aperture optics concept. Commercial interest