N/A
Completed N=10
Study Comparing the P200TE and the P200TxE in Glaucoma Patients
Source: ClinicalTrials.gov NCT03912584 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcomePrimary: Qualitative B-Scan Assessment — 2.78; 2.77; 2.08 Mean score on a scale (0-3)
Summary
The study evaluates the image quality between two OCT devices.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Qualitative B-Scan Assessment |
2.78; 2.77; 2.08 | — |
| SECONDARY Number of Participants With Adverse Events |
0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03912584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.