Glaucoma Evaluation With the P200TE

Optos

Status

Enrolling

Conditions

Glaucoma

Treatments

Device: P200TE

Study type

Interventional

Funder types

Industry

Identifiers

NCT06305481

OPT1099

Details and patient eligibility

About

Images captured on the P200TE device on glaucoma patients

Enrollment

75 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.