PCI Imaging System in Pediatric Ophthalmology (NCT02617862) | Clinical Trial Compass
TerminatedNot Applicable
PCI Imaging System in Pediatric Ophthalmology
Stopped: Proposed comparison (RetCam vs. COSMOS) was unfeasible. Device is now licensed in Canada.
Canada6 participantsStarted 2015-10
Plain-language 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).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of the field of view in RetCam and COSMOS images
Timeframe: 1 day
2
Comparison of the color in RetCam and COSMOS images
Timeframe: 1 day
3
Comparison of the dynamic range in RetCam and COSMOS images
Timeframe: 1 day
4
Comparison of the sharpness in RetCam and COSMOS images
Timeframe: 1 day
5
Comparison of the detail in RetCam and COSMOS images
Timeframe: 1 day
6
Comparison of the resolution in RetCam and COSMOS images
Timeframe: 1 day
7
Comparison of the evenness of illumination in RetCam and COSMOS images