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P200TE Agreement and Precision Study | Clinical Trials | Clareo Health

TERMINATEDNA

P200TE Agreement and Precision Study

NCT05536401•Optos, PLC

Summary

This study is a prospective comparative, randomized, single center study to assess agreement and precision of the P200TE in comparison to the predicate device in normal subjects, subjects with glaucoma, and subjects with retinal disease.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subjects 22 years of age or older on the date of informed consent
•2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
•3. Subjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens
•4. BCVA 20/40 or better (each eye) on the date of the study visit
•1. Subjects 22 years of age or older on the date of informed consent
•2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
•3. BCVA 20/40 or better in the study eye
•4. 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:
•1. On pattern deviation (PD), there exists 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;
•2. Glaucoma hemi-field test "outside normal limits."
+8 more criteria

Exclusion Criteria

•1. Subjects unable to tolerate ophthalmic imaging
•2. Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
•3. 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
•4. Presence of any ocular pathology except for cataract in either eye
•1. Subjects unable to tolerate ophthalmic imaging
•2. Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
•3. 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
•4. No reliable Humphrey Field Analyzer (HFA) visual field (24-2 Sita Standard or Fast, white on white) 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
•5. Presence of any ocular pathology except glaucoma in the study eye
•1. Subjects unable to tolerate ophthalmic imaging
+3 more criteria

Locations (1)

Illinois College of Optometry

Chicago, Illinois, United States

Key Dates

Start Date

September 2, 2022

Primary Completion Date

September 20, 2022

Completion Date

September 20, 2022

Last Updated

November 17, 2022

Enrollment

ACTUAL participants

Conditions

Retina DiseaseGlaucomaNormal

Interventions

P200TE

DEVICE

Predicate Device

DEVICE

Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making

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Normal Physiology

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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P200TE Agreement and Precision Study

Inclusion Criteria

Exclusion Criteria

Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making

Targeting Real World Usage In Stroke Treatment

Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

MRI Study of Musculoskeletal Function

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