title: Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery.
abstract: OBJECTIVE
  To compare the efficacy and safety of intracameral (IC) administration at the beginning of cataract surgery, of Mydrane, a standardised ophthalmic combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%, to a standard topical regimen.
  
  
  METHODS
  In this international phase III, prospective, randomised study, the selected eye of 555 patients undergoing phacoemulsification with intraocular lens (IOL) implantation received 200 μL of Mydrane (Mydrane group) just after the first incision or a topical regimen of one drop each of tropicamide 0.5% and phenylephrine 10% repeated three times (reference group). The primary efficacy variable was achievement of capsulorhexis without additional mydriatics. The non-inferiority of Mydrane to the topical regimen was tested. The main outcome measures were pupil size, patient perception of ocular discomfort and safety.
  
  
  RESULTS
  Capsulorhexis without additional mydriatics was performed in 98.9% of patients and 94.7% in the Mydrane and reference groups, respectively. Both groups achieved adequate mydriasis (>7 mm) during capsulorhexis, phacoemulsification and IOL insertion. IOL insertion was classified as 'routine' in a statistically greater number of eyes in the Mydrane group compared with the reference group (p=0.047). Patients in the Mydrane group reported statistically greater comfort than the reference group before IOL insertion (p=0.034). Safety data were similar between groups.
  
  
  CONCLUSIONS
  Mydrane is an effective and safe alternative to standard eye drops for initiating and maintaining intraoperative mydriasis and analgesia. Patients who received IC Mydrane were significantly more comfortable before IOL insertion than the reference group. Surgeons found IOL insertion less technically challenging with IC Mydrane.
  
  
  BACKGROUND
  NCT02101359; Results.
authors.affiliation: Hôpital Bicêtre, APHP, South Paris University, Ophtalmology, Le Kremlin-Bicêtre, France.|Institute for Integrative Biology of the Cell (I2BC), Département de Virologie, CNRS, Gif/Yvette, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Labetoulle
authors.affiliation: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna, Austria.
authors.forename: Oliver
authors.initials: O
authors.lastname: Findl
authors.affiliation: Hôpital Purpan, CHU de Toulouse, Toulouse, France.
authors.forename: François
authors.initials: F
authors.lastname: Malecaze
authors.affiliation: Instituto Oftalmologico de Alicante, Alicante, Spain.
authors.forename: Jorge
authors.initials: J
authors.lastname: Alió
authors.affiliation: CHU Morvan, Brest, France.
authors.forename: Béatrice
authors.initials: B
authors.lastname: Cochener
authors.affiliation: Association for Innovation and Biomedical Research on Light and Image (AIBILI), Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
authors.forename: Conceição
authors.initials: C
authors.lastname: Lobo
authors.affiliation: Centre d'ophtalmologie, Lazreg, Algeria.
authors.forename: Sihem
authors.initials: S
authors.lastname: Lazreg
authors.affiliation: CHU Mustapha, Alger, Algérie.
authors.forename: Dahbia
authors.initials: D
authors.lastname: Hartani
authors.affiliation: Hôpital Pellegrin Tripode, Bordeaux, France.
authors.forename: Joseph
authors.initials: J
authors.lastname: Colin
authors.affiliation: Universitair Ziekenhuis Antwerpen, Edegem, Belgium.
authors.forename: Marie-José
authors.initials: MJ
authors.lastname: Tassignon
authors.affiliation: Umeå University Hospital, Umeå, Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Behndig
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000779:Anesthetics, Local / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019654:Lens Implantation, Intraocular / Q000379:methods; D008012:Lidocaine / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D015878:Mydriasis / Q000139:chemically induced*; D009184:Mydriatics / Q000008:administration & dosage; D009883:Ophthalmic Solutions; D017060:Patient Satisfaction; D018918:Phacoemulsification / Q000379:methods*; D010656:Phenylephrine / Q000008:administration & dosage*; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014331:Tropicamide / Q000008:administration & dosage*
chemical_list: D000779:Anesthetics, Local; D009184:Mydriatics; D009883:Ophthalmic Solutions; D010656:Phenylephrine; D008012:Lidocaine; D014331:Tropicamide
keywords: Clinical Trial; Conjunctiva; Cornea; Drugs; Inflammation