Back to resultsPCI Imaging System in Pediatric Ophthalmology
Primary Purpose
Retinoblastoma
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Examination under anaesthetic (EUA)
RetCam
COSMOS
Sponsored by
About this trial
This is an interventional diagnostic trial for Retinoblastoma focused on measuring Diagnostic imaging, Retina, Pediatrics
Eligibility Criteria
Exclusion Criteria:
- 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.
Inclusion Criteria:
- Current patients undergoing clinically indicated EUA and RetCam imaging for surveillance and treatment of ophthalmic conditions at The Hospital for Sick Children.
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PCI imaging system
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02617862
First Posted
November 5, 2015
Last Updated
February 8, 2018
Sponsor
Brenda Gallie
Collaborators
Phoenix Clinical Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02617862
Brief Title
PCI Imaging System in Pediatric Ophthalmology
Official Title
The Use of the PCI Wide Field Imaging System for Pediatric Ophthalmic Photography of the Posterior and Peripheral Retina
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Proposed comparison (RetCam vs. COSMOS) was unfeasible. Device is now licensed in Canada.
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brenda Gallie
Collaborators
Phoenix Clinical Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinoblastoma
Keywords
Diagnostic imaging, Retina, Pediatrics
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PCI imaging system
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Examination under anaesthetic (EUA)
Intervention Description
The EUA is scheduled as part of the routine clinical management of children with various ophthalmic conditions.
Intervention Type
Device
Intervention Name(s)
RetCam
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
COSMOS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of the field of view in RetCam and COSMOS images
Description
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.
Time Frame
1 day
Title
Comparison of the color in RetCam and COSMOS images
Description
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.
Time Frame
1 day
Title
Comparison of the dynamic range in RetCam and COSMOS images
Description
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.
Time Frame
1 day
Title
Comparison of the sharpness in RetCam and COSMOS images
Description
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.
Time Frame
1 day
Title
Comparison of the detail in RetCam and COSMOS images
Description
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.
Time Frame
1 day
Title
Comparison of the resolution in RetCam and COSMOS images
Description
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.
Time Frame
1 day
Title
Comparison of the evenness of illumination in RetCam and COSMOS images
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Exclusion Criteria:
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.
Inclusion Criteria:
Current patients undergoing clinically indicated EUA and RetCam imaging for surveillance and treatment of ophthalmic conditions at The Hospital for Sick Children.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda L Gallie, MD, FRCSC
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
PCI Imaging System in Pediatric Ophthalmology
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