title: Bifocal refractive corneal inlay implantation to improve near vision in emmetropic presbyopic patients.
abstract: OBJECTIVE
  To evaluate the safety and effectiveness of the Flexivue Microlens corneal inlay for the improvement of near vision in emmetropic presbyopic patients.
  
  
  METHODS
  Ophthalmology Department, Misericordia e Dolce Hospital, Prato, Italy.
  
  
  METHODS
  Prospective interventional case series.
  
  
  METHODS
  Corneal inlay implantation was performed in nondominant eyes using a 150 kHz femtosecond laser (iFS). Refraction, uncorrected (UNVA) and corrected (CNVA) near visual acuities, uncorrected (UDVA) and corrected (CDVA) distance visual acuities, slitlamp evaluation, wavefront aberrometry, photopic and mesopic contrast sensitivity, anterior segment optical coherence tomography, endothelial cell density, and central corneal thickness measurements were assessed preoperatively and at each postoperative visit.
  
  
  RESULTS
  The study evaluated 81 eyes. In 26 eyes, the mean preoperative UNVA and UDVA were 0.76 logMAR and 0.00 logMAR, respectively, compared with 0.10 logMAR and 0.15 logMAR, respectively, 36 months postoperatively. Sixteen (62%) of 26 treated eyes lost more than 1 line of UDVA, and 5 (19%) lost more than 2 lines of UDVA. Two eyes (8%) lost more than 1 line of CDVA at 36 months. The mean binocular UDVA was 0.00 logMAR preoperatively and 0.02 logMAR at 36 months. The mean spherical aberration increased after surgery. Statistically significant differences in the mean mesopic and photopic contrast sensitivities at higher spatial frequencies were found between treated eyes and nontreated eyes. Explantation was performed in 6 treated eyes because of halos, glare, and a reduced UDVA.
  
  
  CONCLUSIONS
  The corneal inlay might be a safe and effective method of improving UNVA in emmetropic presbyopic patients.
  
  
  BACKGROUND
  Dr. Fantozzi is a member of the Presbia medical advisory board. No other author has a financial or proprietary interest in any material or method mentioned.
authors.affiliation: From the Ophthalmology Department (Malandrini, Menabuoni, Catanese, Corsani, Fantozzi), Misericordia e Dolce Hospital, Prato, and the Ophthalmology Department (Martone, Tosi, Balestrazzi), University of Siena, Siena, Italy.
authors.forename: Alex
authors.initials: A
authors.lastname: Malandrini
authors.affiliation: From the Ophthalmology Department (Malandrini, Menabuoni, Catanese, Corsani, Fantozzi), Misericordia e Dolce Hospital, Prato, and the Ophthalmology Department (Martone, Tosi, Balestrazzi), University of Siena, Siena, Italy. Electronic address: gianlucamartone@unisi.it.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Martone
authors.affiliation: From the Ophthalmology Department (Malandrini, Menabuoni, Catanese, Corsani, Fantozzi), Misericordia e Dolce Hospital, Prato, and the Ophthalmology Department (Martone, Tosi, Balestrazzi), University of Siena, Siena, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Menabuoni
authors.affiliation: From the Ophthalmology Department (Malandrini, Menabuoni, Catanese, Corsani, Fantozzi), Misericordia e Dolce Hospital, Prato, and the Ophthalmology Department (Martone, Tosi, Balestrazzi), University of Siena, Siena, Italy.
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Catanese
authors.affiliation: From the Ophthalmology Department (Malandrini, Menabuoni, Catanese, Corsani, Fantozzi), Misericordia e Dolce Hospital, Prato, and the Ophthalmology Department (Martone, Tosi, Balestrazzi), University of Siena, Siena, Italy.
authors.forename: Gian Marco
authors.initials: GM
authors.lastname: Tosi
authors.affiliation: From the Ophthalmology Department (Malandrini, Menabuoni, Catanese, Corsani, Fantozzi), Misericordia e Dolce Hospital, Prato, and the Ophthalmology Department (Martone, Tosi, Balestrazzi), University of Siena, Siena, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Balestrazzi
authors.affiliation: From the Ophthalmology Department (Malandrini, Menabuoni, Catanese, Corsani, Fantozzi), Misericordia e Dolce Hospital, Prato, and the Ophthalmology Department (Martone, Tosi, Balestrazzi), University of Siena, Siena, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Corsani
authors.affiliation: From the Ophthalmology Department (Malandrini, Menabuoni, Catanese, Corsani, Fantozzi), Misericordia e Dolce Hospital, Prato, and the Ophthalmology Department (Martone, Tosi, Balestrazzi), University of Siena, Siena, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Fantozzi
mesh_terms: D057128:Aberrometry; D000328:Adult; D001672:Biocompatible Materials; D002452:Cell Count; D015350:Contrast Sensitivity / Q000502:physiology; D003319:Corneal Stroma / Q000601:surgery*; D058453:Emmetropia / Q000502:physiology*; D004728:Endothelium, Corneal / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008768:Methylmethacrylates; D008875:Middle Aged; D009216:Myopia / Q000503:physiopathology / Q000601:surgery*; D011102:Polyhydroxyethyl Methacrylate; D011305:Presbyopia / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D019736:Prostheses and Implants; D019919:Prosthesis Implantation; D041623:Tomography, Optical Coherence; D014792:Visual Acuity / Q000502:physiology
chemical_list: D001672:Biocompatible Materials; D008768:Methylmethacrylates; D011102:Polyhydroxyethyl Methacrylate; C040206:HTR composite