PCI Imaging System in Pediatric Ophthalmology

NCT ID: NCT02617862

Last Updated: 2018-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-09-30

Brief Summary

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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

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Conditions

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Retinoblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PCI imaging system

Group Type EXPERIMENTAL

Examination under anaesthetic (EUA)

Intervention Type PROCEDURE

The EUA is scheduled as part of the routine clinical management of children with various ophthalmic conditions.

RetCam

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Interventions

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Examination under anaesthetic (EUA)

The EUA is scheduled as part of the routine clinical management of children with various ophthalmic conditions.

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phoenix Clinical Inc.

INDUSTRY

Sponsor Role collaborator

Brenda Gallie

OTHER

Sponsor Role lead

Responsible Party

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Brenda Gallie

Ophthalmologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Brenda L Gallie, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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Sickkids

Identifier Type: -

Identifier Source: org_study_id

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