title: Morphologic study of the cornea by in vivo confocal microscopy and optical coherence tomography after bifocal refractive corneal inlay implantation.
abstract: OBJECTIVE
  To evaluate the biocompatibility of the Flexivue Microlens intracorneal inlay based on healing of corneal wounds and analysis of corneal structural features using in vivo confocal microscopy (IVCM) and anterior segment optical coherence tomography (AS-OCT).
  
  
  METHODS
  Ophthalmology Department, Misericordia e Dolce Hospital, Prato, Italy.
  
  
  METHODS
  Case series.
  
  
  METHODS
  The intracorneal inlay was inserted in a stromal pocket created in the nondominant eye of emmetropic presbyopic patients using a femtosecond laser. In vivo confocal microscopy and AS-OCT examinations were performed preoperatively and 1, 6, and 12 months postoperatively.
  
  
  RESULTS
  The mean follow-up was 7.6 months. In the early postoperative period, IVCM showed intense cellular activity in the stroma around the inlay, edema, inflammation, and degenerative material deposition but normal regularity after 12 months. Anterior segment OCT showed a regular planar shape of the corneal pocket in all eyes. The mean of the side-cut angles was 30.7 degrees. The mean difference between the measured and planned pocket depth was 9.77 μm. At 1 month, hyperreflective areas beneath the inlay and microfolds were observed in 21 of the 52 eyes. After 12 months, the anterior segment profile was regular and interface pocket reflectivity decreased over time. Six patients had inlay removal postoperatively (3 before 6 months; 3 before 12 months); after removal, IVCM and AS-OCT showed clear corneas without signs of irregularity.
  
  
  CONCLUSIONS
  In vivo confocal microscopy and AS-OCT analysis showed that the inlay elicited a low-level wound-healing response in its immediate vicinity with no alteration in the corneal structures.
  
  
  BACKGROUND
  Dr. M. 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 Department of Ophthalmology (Malandrini, Canovetti, Menabuoni, C. Fantozzi, M. Fantozzi, Lenzetti), Misericordia e Dolce Hospital, Prato, and the Department of Ophthalmology (Martone, Balestrazzi), University of Siena, Siena, Italy. Electronic address: alexmalandrini@libero.it.
authors.forename: Alex
authors.initials: A
authors.lastname: Malandrini
authors.affiliation: From the Department of Ophthalmology (Malandrini, Canovetti, Menabuoni, C. Fantozzi, M. Fantozzi, Lenzetti), Misericordia e Dolce Hospital, Prato, and the Department of Ophthalmology (Martone, Balestrazzi), University of Siena, Siena, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Martone
authors.affiliation: From the Department of Ophthalmology (Malandrini, Canovetti, Menabuoni, C. Fantozzi, M. Fantozzi, Lenzetti), Misericordia e Dolce Hospital, Prato, and the Department of Ophthalmology (Martone, Balestrazzi), University of Siena, Siena, Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Canovetti
authors.affiliation: From the Department of Ophthalmology (Malandrini, Canovetti, Menabuoni, C. Fantozzi, M. Fantozzi, Lenzetti), Misericordia e Dolce Hospital, Prato, and the Department of Ophthalmology (Martone, Balestrazzi), University of Siena, Siena, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Menabuoni
authors.affiliation: From the Department of Ophthalmology (Malandrini, Canovetti, Menabuoni, C. Fantozzi, M. Fantozzi, Lenzetti), Misericordia e Dolce Hospital, Prato, and the Department of Ophthalmology (Martone, Balestrazzi), University of Siena, Siena, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Balestrazzi
authors.affiliation: From the Department of Ophthalmology (Malandrini, Canovetti, Menabuoni, C. Fantozzi, M. Fantozzi, Lenzetti), Misericordia e Dolce Hospital, Prato, and the Department of Ophthalmology (Martone, Balestrazzi), University of Siena, Siena, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Fantozzi
authors.affiliation: From the Department of Ophthalmology (Malandrini, Canovetti, Menabuoni, C. Fantozzi, M. Fantozzi, Lenzetti), Misericordia e Dolce Hospital, Prato, and the Department of Ophthalmology (Martone, Balestrazzi), University of Siena, Siena, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Lenzetti
authors.affiliation: From the Department of Ophthalmology (Malandrini, Canovetti, Menabuoni, C. Fantozzi, M. Fantozzi, Lenzetti), Misericordia e Dolce Hospital, Prato, and the Department of Ophthalmology (Martone, Balestrazzi), University of Siena, Siena, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Fantozzi
mesh_terms: D001672:Biocompatible Materials; D003315:Cornea / Q000473:pathology*; D003319:Corneal Stroma / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008422:Materials Testing; D018613:Microscopy, Confocal; D008875:Middle Aged; D011145:Polyvinyls; D011305:Presbyopia / Q000601:surgery*; D011446:Prospective Studies; D019736:Prostheses and Implants; D019919:Prosthesis Implantation; D013524:Surgical Flaps; D041623:Tomography, Optical Coherence; D014945:Wound Healing; D005465:Fluorocarbon Polymers
chemical_list: D001672:Biocompatible Materials; D011145:Polyvinyls; C024865:polyvinylidene fluoride; D005465:Fluorocarbon Polymers