Principal Investigator: Emil Chynn, M.D.
Sponsor: New Vision, Inc.
Protocol Number: 3.0
Study Title: “Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking at an Irradiance of 18mW/cm2, 30mW/cm2, 45mW/cm2 in Eyes with Keratoconus or Ectasia”
At a previously convened IRB meeting of IntegReview held on November 17, 2015, approval for the above referenced study was granted. The following protocol information has previously been approved;
protocol(s), Version 3.0 dated 10-05-2015.
Upon review of the study site(s) information and your qualifications as a principal investigator for this study, the following action was taken on December 17, 2015 through expedited review by Charles Ryan, Ph.D.:
Investigative site(s) as submitted with initial submission documents
Informed Consent, English language, dated December 17, 2015
The Board also reviewed previous study information for the device(s).
The Board has determined this study to be of non-significant risk.
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