Study Comparing the P200TE and the P200TxE in Glaucoma Patients

Study Overview
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Brief Summary
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The study evaluates the image quality between two OCT devices.

Detailed Description
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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.

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

Conditions
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Glaucoma

Intervention / Treatment
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* Device: P200TE
* Device: P200TxE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Optical Coherence Tomographer<br> | Device: P200TE<br>* The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.<br>Device: P200TxE<br>* The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative B-Scan Assessment | Scores will be based on a 4 point grading scale (0 to 3), with 0 corresponding to failure, 1 is poor, 2 is fair, and 3 is good. The four point scale is defined as follows: 0 indicates the scan is a failure, and contains no clinically useful information. No relevant structures are visible in the scan. indicates the condition of the structure or feature being assessed is poor, and it contains very limited clinical utility. indicates the condition of the structure or feature being assessed is fair or average. It contains some useful clinical information and therefore provides adequate clinical utility. indicates the condition of the structure or feature being assessed is good. It contains useful clinical information. The clinical utility is high or good. | 1 day (start: April 29, 2019 - completed: April 30, 2019) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form. No AEs were recorded during this study. | 1 day |