Glaucoma Evaluation With the P200TE

NCT06305481 | Completed FDA Device

• 1 other identifier: OPT1099
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

Images captured on the P200TE device on glaucoma patients

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Number of images collected

  1 year

Study Arms (1)

Imaging Device

OTHER

Various scans will be captured

Device: P200TE

Interventions

P200TE DEVICE

SLO and OCT imaging

Also known as: OCT Device

Imaging Device

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects were 22 years of age or older on the date of informed consent;
• Subjects were able to understand the written informed consent and willing to participate as evidenced by signing the informed consent;
• BCVA 20/40 or better in the study eye;
• History of visual field defects within the previous year from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings:
• On pattern deviation (PD), there existed a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; or Glaucoma hemi-field test "outside normal limits;"
• Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities: Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage; and Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.

You may not qualify if:

• Subjects unable to tolerate ophthalmic imaging;
• Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye;
• 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;
• No reliable visual field test result within the past year of the study visit, defined as fixation losses \> 33% or false positives \>33%, or false negatives \>33% in the study eye;
• Presence of any ocular pathology except glaucoma in the study eye.

Sponsors & Collaborators

• Optos, PLC: lead

Study Sites (2)

Werner Optometry

Cajon, California, 92019, United States

Location

Specialty Eyecare Centre

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: February 13, 2024
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (2)