P200TE US Reference Database Study

Optos, PLC954 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

954

Conditions

Normal Eyes

Interventions

P200TEDEVICE

The P200TE provides OCT imaging including retinatopography and ONH (optic nerve head) scans.

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects 22 years of age or older on the date of informed consent 2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. 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. 4. BCVA (best corrected visual acuity) 20/40 or better(each eye) 5. Subject is able to comply with the study procedures Exclusion Criteria: 1. Subjects unable to tolerate ophthalmic imaging 2. 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 3. Subject with ocular media not sufficiently clear toobtain acceptable OCT images 4. .History of leukemia, dementia or multiple sclerosis

Locations (9)

Marshall B Ketchum University, Southern California College of Optometry

Anaheim, California, United States

Werner Optometry

San Diego, California, United States

Eyecare of San Diego

San Diego, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 year

GCC Thickness

The GCC Thickness

Time frame: 1 year

RNFL Thickness

The RNFL thickness

Time frame: 1 year

Optic Nerve Head

The ONH size

Time frame: 1 year

Secondary Outcomes

Adverse Events

Number of any adverse events associated with the clinical study to ensure device safety.

Time frame: 1 year

Data from ClinicalTrials.gov

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