Topcon 3D OCT-1 Maestro Reference Database Study II



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2015
End Date:October 2015

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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%.

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%.

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
We found this trial at
7
sites
Livermore, California 94550
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Livermore, CA
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2575 Yorba Linda Boulevard
Fullerton, California 92831
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Fullerton, CA
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Birmingham, Alabama 35294
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Birmingham, AL
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Chicago, Illinois 60616
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Chicago, IL
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Jamaica, New York 11425
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Jamaica, NY
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New York, New York 10036
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New York, NY
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Pomona, California 91766
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Pomona, CA
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