The Sensitivity of Clinical Outcomes to Centration on the Light-Constricted Pupil for a Shape-Changing Corneal Inlay.

PURPOSE: To assess the clinically acceptable range of inlay decentration with respect to the light-constricted pupil center and the coaxially sighted corneal light reflex (CSCLR) for an inlay (Raindrop Near Vision Inlay; ReVision Optics, Inc., Lake Forest, CA) that reshapes the anterior corneal surface.

METHODS: In this retrospective, observational cohort study of 115 patients with emmetropic or low hyperopic presbyopia who were implanted with a shape-changing corneal inlay, visual acuity, task performance (in good and dim light), reports of halos and glare, and satisfaction data were collected from the preoperative and 3-month postoperative examinations. Inlay centration with respect to the pupil center and CSCLR was determined from the center of the inlay effect derived from iTrace (Tracey Technologies, Houston, TX) wavefront measurements. Multivariate regression models assessed the influence of inlay position on visual outcomes.

RESULTS: On average, monocular uncorrected near visual acuity (UNVA) improved 4.9 ± 1.7 lines in the treated eye, with no loss in binocular distance vision. Eighty-three percent of implants were centered radially within 0.5 mm of the pupil center. Multivariate analysis of decentration with respect to both the pupil center and CSCLR revealed no significant interaction with the above clinical outcomes, with the exception of UNVA in the treated eye (all P > .05, α = 0.05). For decentration of less than 0.75 mm, the change in UNVA was less than 1 line.

CONCLUSIONS: Distance and near visual acuity, task performance, severity of halos and glare, and satisfaction were independent of radial decentration of the Raindrop Near Vision Inlay of less than 0.75 mm from the light-constricted pupil. [J Refract Surg. 2018;34(3):164-170.].