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Completed

NCT Number: NCT05844852

P200TE US Reference Database Study

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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Key information

Conditions

Normal Eyes

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marshall B Ketchum University, Southern California College of Optometry, Anaheim, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

P200TE

Device

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

Primary outcomes

  1. Retinal Thickness

    Time frame: 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.

  2. GCC Thickness

    Time frame: 1 year

    The GCC Thickness

  3. RNFL Thickness

    Time frame: 1 year

    The RNFL thickness

  4. Optic Nerve Head

    Time frame: 1 year

    The ONH size

Secondary outcomes

  1. Adverse Events

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Optos, PLC

Industry

Registry information

Official study title

Optos P200TE US Reference Database Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 6, 2023
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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