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 range

18 Years

Sex

ALL

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%

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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%