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.].

Corneal remodeling after implantation of a shape-changing inlay concurrent with myopic or hyperopic laser in situ keratomileusis.

PURPOSE: To compare the induced addition (add)-power profile and epithelial remodeling between patients receiving hyperopic and myopic laser in situ keratomileusis (LASIK) concurrently with implantation of a corneal shape-changing inlay. SETTING: Specialty clinics in Monterrey and Tijuana, Mexico. DESIGN: Retrospective case series. METHODS: Preoperative hyperopic patients (mean spherical equivalent [SE] treatment +1.71 diopters [D] ± 0.51 [SD]) and myopic patients (mean SE treatment -2.48 ± 1.33 D) had implantation of a Raindrop Near Vision Inlay in the nondominant eye immediately after the excimer laser ablation in both eyes under a corneal flap. Monocular and binocular visual acuities were recorded at 6 m. Wavefront measurement analysis yielded the mean inlay add-power profile, and optical coherence tomography images yielded the mean epithelial remodeling profile. RESULTS: In the inlay eye in the hyperopic group (n = 34) and myopic group (n = 29), the mean uncorrected near visual acuity exceeded 20/25 (85% 20/25 or better), the mean uncorrected distance visual acuity (UDVA) was 20/32 (62% 20/32 or better), and the mean binocular UDVA was 20/18 (100% 20/25 or better). The add-power profiles for the hyperopic and myopic groups were similar. The epithelial thinning profiles were also the same, thinning centrally by approximately 19 µm, and were uncorrelated with the treated refractive error. CONCLUSIONS: After concurrent LASIK and inlay implantation, the visual acuity, induced add-power profile, and epithelial remodeling were the same, regardless of hyperopic or myopic treatment.

Structural Changes Induced by a Corneal Shape-Changing Inlay, Deduced From Optical Coherence Tomography and Wavefront Measurements.

PURPOSE: Changes to the anterior stroma and epithelium induced by a meniscus-shaped corneal inlay are presented. The hypothesis that local curvature is a driver of epithelial remodeling is tested. METHODS: Records of 30 subjects enrolled in a prospective clinical investigation of the inlay, implanted in emmetropic presbyopic subjects, were analyzed. The change to the anterior corneal surface was measured using wavefront techniques. The epithelial thinning profile was measured using Fourier domain optical coherence tomography. The stromal change was calculated from the two measurements. RESULTS: The inlay's volume displaced the stroma anterior to the inlay, which was reflected in the change of Bowman's layer shape. The epithelium anterior to the inlay thinned by 18.4 ± 7.1 µm. Peripheral to the inlay's diameter (2 mm), circumferential epithelial thickening extended the change to the anterior corneal surface to approximately twice the inlay diameter. The central anterior corneal surface rose by 9.8 ± 3.4 µm, creating a progressive add power profile. The epithelial thinning was linearly related to the curvature of the alteration to the anterior surface height, consistent with a theoretical model. CONCLUSIONS: When a meniscus-shaped corneal inlay is placed beneath a corneal flap, the flap's stroma takes on predominately the inlay's shape. The epithelium remodels within a zone approximately twice the inlay diameter, with an anterior corneal height change providing improved near and intermediate vision. The relationship between the epithelial, stromal, and anterior corneal surface changes confirms the hypothesis that epithelial changes are greatest in regions of greater local surface curvature.

Range of refractive independence and mechanism of action of a corneal shape-changing hydrogel inlay: results and theory.

PURPOSE: To demonstrate the independence of visual performance over a range of preoperative refraction and age in presbyopes implanted with a corneal shape-changing inlay (Raindrop Near Vision Inlay). SETTING: Two multispecialty clinics, Monterrey and Tijuana, Mexico. DESIGN: Prospective case series. METHODS: The nondominant eyes of patients were implanted with the hydrogel corneal inlay beneath a femtosecond flap, centered on the pupil. Clinical outcomes included uncorrected near, intermediate, and distance visual acuity (UNVA, UIVA, and UDVA) and patient-assessed task performance in good light and dim light. Statistical analyses assessed the dependencies on preoperative age (45 to 60 years) and preoperative manifest refraction spherical equivalent (MRSE) (-0.5 to +1.5 diopters [D]). Using the inlay effect derived from wavefront measurements, an eye model was created through which letter charts were simulated. RESULTS: The study evaluated eyes of 188 patients. Postoperative UNVA, UIVA, and task performance at these distances in good light was independent of age and preoperative MRSE (P > .05). Postoperative UDVA was weakly dependent on preoperative MRSE, but distance task performance in good light was not (P > .05). In the treated eye, the mean postoperative UNVA was 20/25, UIVA was 20/25, and UDVA was 20/32. The clinical outcomes are explained by consideration of zones within the pupil generating good near, intermediate, and distance image quality. This was confirmed by visual acuity simulations. CONCLUSIONS: The continuous center-near power profile induced by the corneal shape-changing inlay provides good visual acuity and performance from distance through near over a 2.0 D range of preoperative refraction and presbyopic age. FINANCIAL DISCLOSURE: Drs. Steinert, Schwiegerling, Barragán-Garza, and Chayet are consultants to Revision Optics, Inc. Drs. Lang and Holliday and Mr. Roy are employees of Revision Optics, Inc. Drs. Steinert, Schwiegerling, Barragán-Garza, and Chayet have no financial or proprietary interest in any material or method mentioned.

Combined hydrogel inlay and laser in situ keratomileusis to compensate for presbyopia in hyperopic patients: one-year safety and efficacy.

PURPOSE: To perform a feasibility study of the safety and efficacy of a corneal-contouring inlay with concurrent laser in situ keratomileusis (LASIK) to treat hyperopic presbyopia. SETTING: Private clinic, Tijuana, Mexico. DESIGN: Prospective interventional case series. METHODS: Hyperopic patients received LASIK in both eyes and a corneal inlay under the femtosecond laser flap in the nondominant eye. The inlay is designed to reshape the anterior corneal curvature, creating a near-center multifocal refractive effect. Main safety outcomes were retention of preoperative corrected distance and near visual acuities and reports of adverse events. Efficacy was determined through measurements of near, intermediate, and distance visual acuities and patient questionnaires on visual task ability and satisfaction. RESULTS: The study enrolled 16 patients. All eyes with an inlay achieved an uncorrected near visual acuity (UNVA) of 20/32 or better by the 1-week postoperative examination and at every visit thereafter. The mean monocular and binocular UNVA was 20/27 or better at all visits. The mean binocular uncorrected distance visual acuity improved significantly from 20/53 preoperatively to 20/19 postoperatively (P<10(-5)). One inlay was explanted during the study. At 1 year, all 14 patients analyzed were satisfied or very satisfied with their near, distance, and overall vision. CONCLUSIONS: The hydrogel corneal inlay with concurrent LASIK improved uncorrected near, intermediate, and distance visual acuity in hyperopic presbyopic patients with high patient satisfaction and visual task ability. This represents a new indication for this recently developed technology.