Article Text

Download PDFPDF

Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery
  1. Marc Labetoulle1,2,
  2. Oliver Findl3,
  3. François Malecaze4,
  4. Jorge Alió5,
  5. Béatrice Cochener6,
  6. Conceição Lobo7,
  7. Sihem Lazreg8,
  8. Dahbia Hartani9,
  9. Joseph Colin10,
  10. Marie-José Tassignon11,
  11. Anders Behndig12
  12. on behalf of the Intracameral Mydrane Study 2 Group
    1. 1Hôpital Bicêtre, APHP, South Paris University, Ophtalmology, Le Kremlin-Bicêtre, France
    2. 2Institute for Integrative Biology of the Cell (I2BC), Département de Virologie, CNRS, Gif/Yvette, France
    3. 3Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna, Austria
    4. 4Hôpital Purpan, CHU de Toulouse, Toulouse, France
    5. 5Instituto Oftalmologico de Alicante, Alicante, Spain
    6. 6CHU Morvan, Brest, France
    7. 7Association for Innovation and Biomedical Research on Light and Image (AIBILI), Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal
    8. 8Centre d'ophtalmologie, Lazreg, Algeria
    9. 9CHU Mustapha, Alger, Algérie
    10. 10Hôpital Pellegrin Tripode, Bordeaux, France
    11. 11Universitair Ziekenhuis Antwerpen, Edegem, Belgium
    12. 12Umeå University Hospital, Umeå, Sweden
    1. Correspondence to Professor Marc Labetoulle, Service d'Ophtalmologie, Hôpital Bicêtre, APHP, Université Paris Sud. 94275 Le Kremlin-Bicêtre, France; marc.labetoulle{at}bct.aphp.fr

    Abstract

    Background/aims 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.

    Trial registration number NCT02101359; Results.

    • Clinical Trial
    • Conjunctiva
    • Cornea
    • Drugs
    • Inflammation

    This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

    View Full Text

    Statistics from Altmetric.com

    Supplementary materials

    • Supplementary Data

      This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    Linked Articles

    • At a glance
      Keith Barton Jost Jonas James Chodosh