Journal of cataract and refractive surgery · 2015
Range of refractive independence and mechanism of action of a corneal shape-changing hydrogel inlay: results and theory.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Steinert Roger F, Schwiegerling Jim, Lang Alan, Roy Adam, Holliday Keith, Barragán Garza Enrique, Chayet Arturo S
Аннотация
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.
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.