PCI Imaging System in Pediatric Ophthalmology

Brenda Gallie

Status: Terminated

Conditions: Retinoblastoma

Treatments: Device: RetCam; Device: COSMOS; Procedure: Examination under anaesthetic (EUA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02617862

Sickkids

Details and patient eligibility

About

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).

Enrollment: 6 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

PCI imaging system

Experimental group

Treatment:

Procedure: Examination under anaesthetic (EUA)

Device: COSMOS

Device: RetCam