Glaucoma Evaluation With the P200TE
Completed · Not applicable
Conditions studied: Glaucoma
In brief
Images captured on the P200TE device on glaucoma patients
Key facts
- Study ID
- NCT06305481
- Run by
- Optos, PLC
- People needed
- 53
- Starts
- 2024-02-13
- Expected to finish
- 2024-10-23
- Last updated by the study team
- 2026-02-13
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Werner Optometry — Cajon, California, United States
- Specialty Eyecare Centre — Bellevue, Washington, United States
Full record on ClinicalTrials.gov
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