title: Range of refractive independence and mechanism of action of a corneal shape-changing hydrogel inlay: results and theory.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  Two multispecialty clinics, Monterrey and Tijuana, Mexico.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  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.
authors.affiliation: From the Gavin Herbert Eye Institute (Steinert), University of California, Irvine, Revision Optics, Inc. (Lang, Holliday, Roy), Lake Forest, California, the College of Optical Sciences/Ophthalmology (Schwiegerling), University of Arizona, Tucson, Arizona, USA; Laser Ocular Hidalgo (Barragán), Monterrey, and the Codet Aris Vision Institute (Chayet), Tijuana, Mexico. Electronic address: steinert@uci.edu.
authors.forename: Roger F
authors.initials: RF
authors.lastname: Steinert
authors.affiliation: From the Gavin Herbert Eye Institute (Steinert), University of California, Irvine, Revision Optics, Inc. (Lang, Holliday, Roy), Lake Forest, California, the College of Optical Sciences/Ophthalmology (Schwiegerling), University of Arizona, Tucson, Arizona, USA; Laser Ocular Hidalgo (Barragán), Monterrey, and the Codet Aris Vision Institute (Chayet), Tijuana, Mexico.
authors.forename: Jim
authors.initials: J
authors.lastname: Schwiegerling
authors.affiliation: From the Gavin Herbert Eye Institute (Steinert), University of California, Irvine, Revision Optics, Inc. (Lang, Holliday, Roy), Lake Forest, California, the College of Optical Sciences/Ophthalmology (Schwiegerling), University of Arizona, Tucson, Arizona, USA; Laser Ocular Hidalgo (Barragán), Monterrey, and the Codet Aris Vision Institute (Chayet), Tijuana, Mexico.
authors.forename: Alan
authors.initials: A
authors.lastname: Lang
authors.affiliation: From the Gavin Herbert Eye Institute (Steinert), University of California, Irvine, Revision Optics, Inc. (Lang, Holliday, Roy), Lake Forest, California, the College of Optical Sciences/Ophthalmology (Schwiegerling), University of Arizona, Tucson, Arizona, USA; Laser Ocular Hidalgo (Barragán), Monterrey, and the Codet Aris Vision Institute (Chayet), Tijuana, Mexico.
authors.forename: Adam
authors.initials: A
authors.lastname: Roy
authors.affiliation: From the Gavin Herbert Eye Institute (Steinert), University of California, Irvine, Revision Optics, Inc. (Lang, Holliday, Roy), Lake Forest, California, the College of Optical Sciences/Ophthalmology (Schwiegerling), University of Arizona, Tucson, Arizona, USA; Laser Ocular Hidalgo (Barragán), Monterrey, and the Codet Aris Vision Institute (Chayet), Tijuana, Mexico.
authors.forename: Keith
authors.initials: K
authors.lastname: Holliday
authors.affiliation: From the Gavin Herbert Eye Institute (Steinert), University of California, Irvine, Revision Optics, Inc. (Lang, Holliday, Roy), Lake Forest, California, the College of Optical Sciences/Ophthalmology (Schwiegerling), University of Arizona, Tucson, Arizona, USA; Laser Ocular Hidalgo (Barragán), Monterrey, and the Codet Aris Vision Institute (Chayet), Tijuana, Mexico.
authors.forename: Enrique
authors.initials: E
authors.lastname: Barragán Garza
authors.affiliation: From the Gavin Herbert Eye Institute (Steinert), University of California, Irvine, Revision Optics, Inc. (Lang, Holliday, Roy), Lake Forest, California, the College of Optical Sciences/Ophthalmology (Schwiegerling), University of Arizona, Tucson, Arizona, USA; Laser Ocular Hidalgo (Barragán), Monterrey, and the Codet Aris Vision Institute (Chayet), Tijuana, Mexico.
authors.forename: Arturo S
authors.initials: AS
authors.lastname: Chayet
mesh_terms: D001672:Biocompatible Materials; D003315:Cornea / Q000503:physiopathology*; D003319:Corneal Stroma / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011145:Polyvinyls; D011305:Presbyopia / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D019736:Prostheses and Implants; D019919:Prosthesis Implantation; D012029:Refraction, Ocular / Q000502:physiology*; D013524:Surgical Flaps; D011795:Surveys and Questionnaires; D014792:Visual Acuity / Q000502:physiology*; D005465:Fluorocarbon Polymers
chemical_list: D001672:Biocompatible Materials; D011145:Polyvinyls; C024865:polyvinylidene fluoride; D005465:Fluorocarbon Polymers