OCT Reference Database



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:5/3/2014
Start Date:October 2013
End Date:April 2014
Contact:Michael Sinai, PhD
Email:msinai@topcon.com
Phone:760-476-3305

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Topcon 3D OCT-1 Maestro and 3D OCT-2000 Optical Coherence Tomography Systems: Reference Database Study

To collect data for a reference database.

Collection of multiple subjects to create a reference database.

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
We found this trial at
5
sites
Los Angeles, California 90033
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Los Angeles, CA
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Livermore, California 94550
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Livermore, CA
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New York, NY
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Pomona, California 91766
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Pomona, CA
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Scottsdale, Arizona 85054
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Scottsdale, AZ
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