Evaluating glaucoma using the P200TE device

Glaucoma Evaluation With the P200TE

This study is testing a new device called the P200TE to see if it can capture better images of the eyes in people with glaucoma to help manage their condition.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Optos, PLC (Industry-sponsored)
• Locations: 2 sites (Cajon, California and 1 other locations)
• Trial ID: NCT06305481 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the P200TE device in capturing images of glaucoma patients. Participants aged 22 and older with a history of visual field defects and specific optic nerve damage will be enrolled. The study aims to assess the device's ability to provide valuable imaging data that could enhance glaucoma management. By focusing on patients with confirmed glaucomatous changes, the study seeks to improve diagnostic accuracy and treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 22 or older with a history of visual field defects and confirmed glaucomatous optic nerve damage.

Not a fit: Patients without a history of glaucoma or those with visual acuity worse than 20/40 in the study eye may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic techniques for glaucoma, allowing for better management of the condition.

How similar studies have performed: While specific outcomes from similar studies using advanced imaging devices in glaucoma management are not detailed, the approach of utilizing specialized imaging technology is well-established in the field.

Eligibility criteria

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Where this trial is running

Cajon, California and 1 other locations

• Werner Optometry — Cajon, California, United States (Recruiting)
• Specialty Eyecare Centre — Bellevue, Washington, United States (Recruiting)

Conditions Glaucoma