Topcon 3D OCT-1 Maestro Reference Database Study II

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02447120

Enrollment

504

Registered

2015-05-18

Start date

2015-05-31

Completion date

2015-10-31

Last updated

2022-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Volunteers with Healthy Eyes

Brief 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 3D OCT-1 Maestro based on the percentile points for 1%, 5%, 95%, and 99%.

Detailed description

Interventions

DEVICE3D OCT-1 Maestro

OCT machines used for diagnostic purposes

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

for Normal Group 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. lOP \<= 21 mmHg bilaterally 5. BCVA 20/40 or better (each eye) 6. Both eyes must be free of eye disease

Exclusion criteria

for Normal Group 1. Subjects previously enrolled in either the Maestro AP study or the Maestro2 study 2. Subjects unable to tolerate ophthalmic imaging 3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images 4. 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% 5. Visual field defects consistent with glaucomatous optic nerve damage based on with 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. 6. Presence of any ocular pathology except for cataract 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	1 minute

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026