PCI Imaging System in Pediatric Ophthalmology

Retinoblastoma Clinical Trial

Official title:

The Use of the PCI Wide Field Imaging System for Pediatric Ophthalmic Photography of the Posterior and Peripheral Retina

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02617862
• Other study ID #: Sickkids
• 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
• 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.

Related Conditions & MeSH terms

• Retinoblastoma

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