NCT05615896TerminatedNot Applicable
Data Collection With the P200TE and P200TxE in Diseased Eyes for Clinical Developments
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Optos, PLC
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Collection of images
Study Overview
Brief Summary
The primary objective is to collect OCT scans on a modified P200TxE and P200TE.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female volunteers 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
- •Volunteers who can follow the instructions by the clinical staff at the clinical site;
- •Volunteers who agree to participate;
- •Volunteers who have been diagnosed with retina pathology with intra-retinal and/or subretinal fluid present in the posterior pole region.
Exclusion Criteria
- •Volunteers unable to tolerate ophthalmic imaging;
- •Volunteers with ocular media not sufficiently clear to obtain acceptable OCT images.
Arms & Interventions
P200TE Device First
Experimental
Intervention: Imaging Session (Device)
P200TxE Device First
Experimental
Intervention: Imaging Session (Device)
Outcomes
Primary Outcomes
Collection of images
Time Frame: 1 year
The primary endpoint will be the collection of OCT scans on the P200TE and P200TxE devices. The scans will be used by R\&D for development of a de-noising algorithm as well as other possible developments.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
P200TxE Diseased Eye Image CollectionRetinal DiseaseNCT06269666Optos, PLC100
Completed
Not Applicable
Navigated OCT Imaging With the P200TxERetinal DiseaseNCT04003831Optos, PLC26
Completed
Not Applicable
Image Collection of Normal Eyes for Development of an EU RDBHealthyNCT03783858Optos, PLC356
Completed
Not Applicable
P200TE US Reference Database StudyNormal EyesNCT05844852Optos, PLC954
Terminated
Not Applicable
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to MammographyTumors, BreastBreast CancerNCT02540083GE Healthcare94