Triton Reference Database

Launched by TOPCON CORPORATION · Feb 24, 2017

Keywords

ClinConnect Summary

The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon DRI OCT Triton based on the percentile points for 1%, 5%, 95%, and 99%.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Subjects 18 years of age or older on the date of informed consent
• • 2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
• • 3. Subjects presenting at the site with normal eyes bilaterally (cataracts are acceptable)
• • 4. IOP ≤ 21 mmHg bilaterally
• • 5. BCVA 20/40 or better bilaterally
• • Exclusion Criteria
• • 1. Subjects unable to tolerate ophthalmic imaging
• • 2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images
• • 3. 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%
• 4. Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings:
• • 1. 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;
• • 2. Glaucoma hemi-field test "outside normal limits."
• • 5. Narrow angle
• • 6. History of leukemia, dementia or multiple sclerosis
• • 7. Concomitant use of hydroxychloroquine and chloroquine