Triton Reference Database

Topcon

Status: Completed

Conditions: Healthy Eyes

Treatments: Device: Topcon DRI OCT Triton (plus)

Study type: Observational

Funder types: Industry

Identifiers

NCT03067675

Triton RDB

Details and patient eligibility

About

The objective of this study is to collect OCT measurement data on normal healthy eyes.

Full description

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%.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

500 participants in 1 patient group

Subjects Presenting With Normal Eyes

Description:

Subjects with no known ocular diseases will be scanned on the Topcon DRI OCT Triton (plus) device

Treatment:

Device: Topcon DRI OCT Triton (plus)