Study Stopped
Proposed comparison (RetCam vs. COSMOS) was unfeasible. Device is now licensed in Canada.
PCI Imaging System in Pediatric Ophthalmology
The Use of the PCI Wide Field Imaging System for Pediatric Ophthalmic Photography of the Posterior and Peripheral Retina
1 other identifier
interventional
6
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedFebruary 12, 2018
February 1, 2018
1.9 years
November 5, 2015
February 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Comparison of the field of view in RetCam and COSMOS images
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.
1 day
Comparison of the color in RetCam and COSMOS images
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.
1 day
Comparison of the dynamic range in RetCam and COSMOS images
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.
1 day
Comparison of the sharpness in RetCam and COSMOS images
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.
1 day
Comparison of the detail in RetCam and COSMOS images
Masked investigators will review images from the RetCam and the COSMOS. Detail 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.
1 day
Comparison of the resolution in RetCam and COSMOS images
Masked investigators will review images from the RetCam and the COSMOS. Resolution 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.
1 day
Comparison of the evenness of illumination in RetCam and COSMOS images
Masked investigators will review images from the RetCam and the COSMOS. Evenness of illumination 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.
1 day
Study Arms (1)
PCI imaging system
EXPERIMENTALInterventions
The EUA is scheduled as part of the routine clinical management of children with various ophthalmic conditions.
The RetCam is a pediatric wide-field retinal camera that has been the mainstay for pediatric ophthalmic imaging since 1997. Imaging using the RetCam (during the EUA) is conducted as part of routine clinical magagement.
The COSMOS images will be captured (during the EUA) after the RetCam images. The COSMOS is designed to be used in the same way as the RetCam, but to produce higher quality images.
Eligibility Criteria
You may not qualify if:
- Any patient who has a cloudy cornea.
- Any patient whose RetCam imaging exam easily produces blanching of the optic nerve in the normal course of imaging.
- Any patient who has consented to the procedure, but whose course of examination has filled the time allotted, leaving no time to evaluate the COSMOS.
- Current patients undergoing clinically indicated EUA and RetCam imaging for surveillance and treatment of ophthalmic conditions at The Hospital for Sick Children.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brenda Gallielead
- Phoenix Clinical Inc.collaborator
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G1X8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brenda L Gallie, MD, FRCSC
The Hospital for Sick Children
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Ophthalmologist
Study Record Dates
First Submitted
November 5, 2015
First Posted
December 1, 2015
Study Start
October 1, 2015
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
February 12, 2018
Record last verified: 2018-02