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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02617862
Other study ID # Sickkids
Secondary ID
Status Terminated
Phase N/A
First received November 5, 2015
Last updated February 8, 2018
Start date October 2015
Est. completion date September 2017

Study information

Verified date February 2018
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Examination under anaesthetic (EUA)
The EUA is scheduled as part of the routine clinical management of children with various ophthalmic conditions.
Device:
RetCam
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.
COSMOS
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.

Locations

Country Name City State
Canada The Hospital for Sick Children Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Brenda Gallie Phoenix Clinical Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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