PCI Imaging System in Pediatric Ophthalmology

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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

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).

Study Type

Interventional

Primary Outcome

Comparison of the field of view in RetCam and COSMOS images

Condition

Retinoblastoma

Intervention

Examination under anaesthetic (EUA)

Study Arms / Comparison Groups

 PCI imaging system
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

6

Start Date

October 2015

Completion Date

September 2017

Primary Completion Date

September 2017

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.

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Brenda L Gallie, MD, FRCSC, ,

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT02617862

Organization ID

Sickkids

Responsible Party

Sponsor-Investigator

Study Sponsor

Brenda Gallie

Collaborators

 Phoenix Clinical Inc.

Study Sponsor

Brenda L Gallie, MD, FRCSC, Principal Investigator, The Hospital for Sick Children

Verification Date

February 2018