Clinical Trial: PCI Imaging System in Pediatric Ophthalmology

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Use of the PCI Wide Field Imaging System for Pediatric Ophthalmic Photography of the Posterior and Peripheral Retina

Brief Summary: The purpose of this study is to compare the RetCam (Clarity Medical Systems, Pleasanton, CA) to a new prototype pediatric imaging system, COSMOS, produced by Phoenix Clinical Incorporated (PCI) (Pleasanton, CA).

Detailed Summary:
Sponsor: Brenda Gallie

Current Primary Outcome:

• Comparison of the field of view in RetCam and COSMOS images [ Time Frame: 1 day ]
  Masked investigators will review images from the RetCam and the COSMOS. Field of view will be graded on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
• Comparison of the color in RetCam and COSMOS images [ Time Frame: 1 day ]
  Masked investigators will review images from the RetCam and the COSMOS. Color will be graded on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
• Comparison of the dynamic range in RetCam and COSMOS images [ Time Frame: 1 day ]
  Masked investigators will review images from the RetCam and the COSMOS. Dynamic range will be graded on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
• Comparison of the sharpness in RetCam and COSMOS images [ Time Frame: 1 day ]
  Masked investigators will compare images from the RetCam and the COSMOS and grade sharpness on a scale from 1-5, with 1 being the worst and 5 being the best. We will test for significant difference, at alpha level 0.05, between scores of the images taken by the RetCam and the COSMOS.
• Comparison of the detail in RetCam
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: The Hospital for Sick Children
  

  Dates:
  Date Received: November 5, 2015
  Date Started: October 2015
  Date Completion: October 2017
  Last Updated: October 13, 2016
  Last Verified: October 2016