Study Comparing the P200TE and the P200TxE in Glaucoma Patients

Qualitative OCT Image Grading Study Comparing the P200TE and the P200TxE in Glaucoma Patients

The study evaluates the image quality between two OCT devices.

The objective of this study is to collect OCT scans to compare the qualitative B scan images produced by the P200TxE to the P200TE device in glaucoma subjects.

Inclusion Criteria:

• Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
• Subjects who can follow the instructions by the clinical staff at the clinical site,
• Subjects who agree to participate in the study;
• Subjects who have been diagnosed with glaucoma in the study eye as confirmed by the investigator;

Exclusion Criteria:

• Subjects unable to tolerate ophthalmic imaging;
• Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
• Subjects with any clinically significant ocular pathology except glaucoma, as determined by self-report and/or investigator assessment on the day of the study visit;
• Subjects who are not reliably tested with at least one Humphrey Field Analyzer (HFA) visual field (24-2 or 30-2, white on white) measured on the day of the study visit or within the previous year from the study visit, defined as fixation losses > 20% or false positives > 33%, or false negatives > 33%;
• Subjects with history of dementia or multiple sclerosis