title: Combined hydrogel inlay and laser in situ keratomileusis to compensate for presbyopia in hyperopic patients: one-year safety and efficacy.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Private clinic, Tijuana, Mexico.
  
  
  METHODS
  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.
authors.affiliation: From Codet Vision Institute (Chayet), Tijuana, Baja California, and Laser Ocular Hidalgo (Barragan Garza), Monterrey, Nuevo Leone, Mexico.
authors.forename: Arturo
authors.initials: A
authors.lastname: Chayet
authors.forename: Enrique
authors.initials: E
authors.lastname: Barragan Garza
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003319:Corneal Stroma / Q000601:surgery*; D023882:Dominance, Ocular; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate; D006956:Hyperopia / Q000503:physiopathology / Q000601:surgery*; D020731:Keratomileusis, Laser In Situ / Q000379:methods*; D054018:Lasers, Excimer / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011305:Presbyopia / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D019919:Prosthesis Implantation; D012029:Refraction, Ocular / Q000502:physiology; D013524:Surgical Flaps; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
chemical_list: D020136:Hydrogel, Polyethylene Glycol Dimethacrylate