Topcon 3D OCT-1 Maestro Reference Database Study II

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

504 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-10-31

Brief Summary

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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%.

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Detailed Description

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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%.

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal Eyes

Subjects with no known ocular diseases will be scanned with the Maestro device

3D OCT-1 Maestro

Intervention Type DEVICE

OCT machines used for diagnostic purposes

Interventions

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3D OCT-1 Maestro

OCT machines used for diagnostic purposes

Intervention Type DEVICE

Eligibility Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes