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.

Age range18 Years

SexALL

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

✓. 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

✕. 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;
✕. Glaucoma hemi-field test "outside normal limits."
✕. Narrow angle
✕. History of leukemia, dementia or multiple sclerosis

Retinal Thickness

Timeframe: 1 Minute

NCT IDNCT03080714

SponsorTopcon Medical Systems, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-08-30