PCI Imaging System in Pediatric Ophthalmology

Not Applicable

Terminated

• Conditions: Retinoblastoma
• Interventions: Procedure: Examination under anaesthetic (EUA); Device: RetCam; Device: COSMOS

• Registration Number: NCT02617862
• Lead Sponsor: Brenda Gallie

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 Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-26
• Study First Posted: 2015-12-01
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-08
• Last Update Posted: 2018-02-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Current patients undergoing clinically indicated EUA and RetCam imaging for surveillance and treatment of ophthalmic conditions at The Hospital for Sick Children.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PCI imaging system	RetCam	-
PCI imaging system	COSMOS	-
PCI imaging system	Examination under anaesthetic (EUA)	-

Primary Outcome Measures

Name	Time	Method
Comparison of the field of view in RetCam and COSMOS images	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	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	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	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 resolution in RetCam and COSMOS images	1 day	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 detail in RetCam and COSMOS images	1 day	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 evenness of illumination in RetCam and COSMOS images	1 day	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.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada