Clinical trial · Interventional
PCI Imaging System in Pediatric Ophthalmology
The Use of the PCI Wide Field Imaging System for Pediatric Ophthalmic Photography of the Posterior and Peripheral Retina
NCT02617862CI-TRIAL-00031627terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Proposed comparison (RetCam vs. COSMOS) was unfeasible. Device is now licensed in Canada.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Retinoblastoma | Retinoblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| COSMOS | Device | — | UNRESOLVED |
| Examination under anaesthetic (EUA) | Procedure | — | UNRESOLVED |
| RetCam | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PCI imaging system
- interventionNames
- Procedure: Examination under anaesthetic (EUA)
- Device: RetCam
- Device: COSMOS
Primary outcomes (7)
- measure
- Comparison of the field of view in RetCam and COSMOS images
- timeFrame
- 1 day
- description
- 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.
- measure
- Comparison of the color in RetCam and COSMOS images
- timeFrame
- 1 day
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
* 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.
References
Publications (0)
Data not yet available
No reference posted for this study.