P200TE US Reference Database Study

Not Applicable

Active, not recruiting

• Conditions: Normal Eyes

• 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

Study Timeline

• Study Start: 2023-03-14
• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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)

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

Center for Sight; 🇺🇸 Venice, Florida, United States

Illinois College of Optometry; 🇺🇸 Chicago, Illinois, United States

New England College of Optometry; 🇺🇸 Roslindale, Massachusetts, United States

State University of New York, Clinical Vision Research; 🇺🇸 New York, New York, United States

Specialty Eye Care Centre; 🇺🇸 Bellevue, Washington, United States