Healthy
Conditions
Brief summary
To collect data for a reference database.
Detailed description
Collection of multiple subjects to create a reference database.
Interventions
None listed
Sponsors
Topcon Medical Systems, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 (eyes without pathology) 4. IOP ≤ 21 mmHg bilaterally 5. BCVA 20/40 or better (each eye) 6. Both eyes must be free of eye disease
Exclusion criteria
1. Subjects unable to tolerate ophthalmic imaging 2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images 3. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \< 5% 4. 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% 5. Presence of any ocular pathology except for cataract 6. Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning 7. Narrow angle 8. History of leukemia, dementia or multiple sclerosis 9. Concomitant use of hydroxychloroquine and chloroquine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retinal Thickness | Day 1 |
Countries
United States
Outcome results
None listed