P200TE US Reference Database Study

Optos 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Normal Eyes
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92807
      • Marshall B Ketchum University, Southern California College of Optometry
    • San Diego, California, United States, 92019
      • Werner Optometry
    • San Diego, California, United States, 92103
      • Eyecare of San Diego
  • Florida
    • Venice, Florida, United States, 34292
      • Center For Sight
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Illinois College of Optometry
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • New England College of Optometry
    • Roslindale, Massachusetts, United States, 02131
      • New England College of Optometry
  • New York
    • New York, New York, United States, 10036
      • State University of New York, Clinical Vision Research
  • Washington
    • Bellevue, Washington, United States, 98004
      • Specialty Eye Care Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: OCT; Device: P200TE The P200TE provides OCT imaging including retina topography and ONH (optic nerve head) scans.	Device: P200TE; The P200TE provides OCT imaging including retinatopography and ONH (optic nerve head) scans.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
GCC Thickness	The GCC Thickness	1 year
RNFL Thickness	The RNFL thickness	1 year
Optic Nerve Head	The ONH size	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number of any adverse events associated with the clinical study to ensure device safety.	1 year

Collaborators and Investigators

• Sponsor: Optos, PLC

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: OPT1089

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No