P200TE US Reference Database Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2024-05-01

Brief Summary

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

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Detailed Description

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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

Conditions

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Normal Eyes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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OCT

Device: P200TE The P200TE provides OCT imaging including retina topography and ONH (optic nerve head) scans.

Group Type OTHER

P200TE

Intervention Type DEVICE

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

Interventions

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P200TE

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes