CompletedNot Applicable

Maestro Agreement and Precision Study II

United States101 participantsStarted 2015-05

Plain-language summary

Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, Full Retinal Thickness, and Ganglion Cell Thickness between the Maestro and iVue OCT devices.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects 18 years of age or older on the date of informed consent
✓. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
✓. Subjects presenting at the site with normal eyes (eyes without pathology)
✓. lOP \<=21 mmHg bilaterally
✓. BCVA 20/40 or better (each eye)
✓. Both eyes must be free of eye disease

Exclusion criteria

✕. Subjects previously enrolled in either the Maestro AP study or the Maestro2 study
✕. Subjects unable to tolerate ophthalmic imaging
✕. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
✕. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses\> 20% or false positives\> 33%, or false negatives\> 33%
✕. Visual field defects consistent with glaucomatous optic nerve damage with at least one of the following two findings:
✕. 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;

What they're measuring

Optic Disc Measurements (Optic Disc/Cup Size)

Timeframe: 1 Hour

Retinal Nerve Fiber Layer (RNFL) Thickness Measurements At Different Clock Hours

Timeframe: 1 Hour

Full Retinal Thickness Measurements

Timeframe: 1 Hour

Ganglion Cell Thickness Measurements

Timeframe: 1 Hour

Trial details

NCT IDNCT02376868

SponsorTopcon Medical Systems, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-09

View on ClinicalTrials.gov More Normal Healthy Subjects With No Known Ocular Diseases trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects 18 years of age or older on the date of informed consent
✓. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
✓. Subjects presenting at the site with normal eyes (eyes without pathology)
✓. lOP \<=21 mmHg bilaterally
✓. BCVA 20/40 or better (each eye)
✓. Both eyes must be free of eye disease

Exclusion criteria

✕. Subjects previously enrolled in either the Maestro AP study or the Maestro2 study
✕. Subjects unable to tolerate ophthalmic imaging
✕. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
✕. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses\> 20% or false positives\> 33%, or false negatives\> 33%
✕. Visual field defects consistent with glaucomatous optic nerve damage with at least one of the following two findings:
✕. 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;