P200TE US Reference Database Study
- Conditions
- Normal Eyes
- Interventions
- Device: P200TE
- Registration Number
- NCT05844852
- Lead Sponsor
- Optos, PLC
- Brief Summary
The objective of this study is to collect Optical Coherence Tomography (OCT) data to construct a reference database for the P200TE.
- Detailed Description
The objective of this study is to collect Optical Coherence Tomography (OCT) data on healthy eyes in order to develop a reference database for the P200TE device in order to determine the reference limits for the P200TE
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 800
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description OCT P200TE Device: P200TE The P200TE provides OCT imaging including retina topography and ONH (optic nerve head) scans.
- Primary Outcome Measures
Name Time Method Optic Nerve Head 1 year The ONH size
GCC Thickness 1 year The GCC Thickness
RNFL Thickness 1 year The RNFL thickness
Retinal Thickness 1 year The full thickness retina grid consists of a 9-sector circular grid pattern centered on the fovea and based on the ETDRS criteria.
- Secondary Outcome Measures
Name Time Method Adverse Events 1 year Number of any adverse events associated with the clinical study to ensure device safety.
Trial Locations
- Locations (8)
New England College of Optometry
🇺🇸Roslindale, Massachusetts, United States
Center for Sight
🇺🇸Venice, Florida, United States
Marshall B Ketchum University, Southern California College of Optometry
🇺🇸Anaheim, California, United States
Eyecare of San Diego
🇺🇸San Diego, California, United States
Illinois College of Optometry
🇺🇸Chicago, Illinois, United States
Specialty Eye Care Centre
🇺🇸Bellevue, Washington, United States
Werner Optometry
🇺🇸San Diego, California, United States
State University of New York, Clinical Vision Research
🇺🇸New York, New York, United States