CompletedNot Applicable

Triton Agreement and Precision Study

United States88 participantsStarted 2017-03-13

Plain-language summary

To Compare the agreement and precision between the Topcon DRI OCT Triton and the 3D OCT-1 Maestro with RDB.

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 bilaterally (cataracts are acceptable)
. IOP ≤ 21 mmHg bilaterally
. BCVA 20/40 or better bilaterally

Exclusion criteria

. Subjects unable to tolerate ophthalmic imaging
. Subjects 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 based on 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;

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

Retinal Thickness

Timeframe: 1 Minute

Trial details

NCT IDNCT03080714

SponsorTopcon Medical Systems, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-08-30

View on ClinicalTrials.gov More Healthy Eyes trials