P200TE US Reference Database Study
Optos P200TE US Reference Database Study
1 other identifier
interventional
800
1 country
9
Brief Summary
The objective of this study is to collect Optical Coherence Tomography (OCT) data to construct a reference database for the P200TE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 14, 2023
CompletedFirst Submitted
Initial submission to the registry
March 30, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedApril 3, 2024
April 1, 2024
1.1 years
March 30, 2023
April 2, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Retinal Thickness
The full thickness retina grid consists of a 9-sector circular grid pattern centered on the fovea and based on the ETDRS criteria.
1 year
GCC Thickness
The GCC Thickness
1 year
RNFL Thickness
The RNFL thickness
1 year
Optic Nerve Head
The ONH size
1 year
Secondary Outcomes (1)
Adverse Events
1 year
Study Arms (1)
OCT
OTHERDevice: P200TE The P200TE provides OCT imaging including retina topography and ONH (optic nerve head) scans.
Interventions
The P200TE provides OCT imaging including retinatopography and ONH (optic nerve head) scans.
Eligibility Criteria
You may qualify if:
- Subjects 22 years of age or older on the date of informed consent
- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subjects presenting at the site with normal eyes (Cataracts, LASIK, PRK (photorefractive keratectomy), and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed.
- BCVA (best corrected visual acuity) 20/40 or better(each eye)
- Subject is able to comply with the study procedures
You may not qualify if:
- Subjects unable to tolerate ophthalmic imaging
- Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- Subject with ocular media not sufficiently clear toobtain acceptable OCT images
- History of leukemia, dementia or multiple sclerosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Optos, PLClead
Study Sites (9)
Marshall B Ketchum University, Southern California College of Optometry
Anaheim, California, 92807, United States
Werner Optometry
San Diego, California, 92019, United States
Eyecare of San Diego
San Diego, California, 92103, United States
Center for Sight
Venice, Florida, 34292, United States
Illinois College of Optometry
Chicago, Illinois, 60616, United States
New England College of Optometry
Boston, Massachusetts, 02215, United States
New England College of Optometry
Roslindale, Massachusetts, 02131, United States
State University of New York, Clinical Vision Research
New York, New York, 10036, United States
Specialty Eye Care Centre
Bellevue, Washington, 98004, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2023
First Posted
May 6, 2023
Study Start
March 14, 2023
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
April 3, 2024
Record last verified: 2024-04