CompletedNot Applicable

Clinical Study of the Optic Disc Parameters

United States109 participantsStarted 2014-10

Plain-language summary

Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, and Full Retinal 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)
✓. lOPs 21mmHg bilaterally
✓. BCVA 20/40 or better (each eye)
✓. Both eyes must be free of eye disease

Exclusion criteria

✕. Subjects that have participated in any previous study using 3D OCT-1 Maestro device.
✕. 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 abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \< 5%
✕. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses\> 33% or false positives \> 25%, or false negatives \> 25%
✕. Presence of any ocular pathology except for cataract
✕. Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning
✕. Narrow angle

What they're measuring

Optic Disc Measurements (Optic Disc Size)

Timeframe: 1 Hour

Retinal Nerve Fiber Layer (RNFL) Thickness Measurements

Timeframe: 1 Hour

Full Retinal Thickness Measurement

Timeframe: 1 Hour

Optic Disc Measurement (Cup Size)

Timeframe: 1 Hour

Trial details

NCT IDNCT02277119

SponsorTopcon Medical Systems, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-01

Results submitted2016-05-31

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)
✓. lOPs 21mmHg bilaterally
✓. BCVA 20/40 or better (each eye)
✓. Both eyes must be free of eye disease

Exclusion criteria

✕. Subjects that have participated in any previous study using 3D OCT-1 Maestro device.
✕. 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 abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \< 5%
✕. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses\> 33% or false positives \> 25%, or false negatives \> 25%
✕. Presence of any ocular pathology except for cataract
✕. Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning
✕. Narrow angle