P200TE US Reference Database Study

Optos

Status

Active, not recruiting

Conditions

Normal Eyes

Treatments

Device: P200TE

Study type

Interventional

Funder types

Industry

Identifiers

NCT05844852

OPT1089

Details and patient eligibility

About

The objective of this study is to collect Optical Coherence Tomography (OCT) data to construct a reference database for the P200TE.

Full 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

Enrollment

800 estimated patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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