Topcon 3D OCT-1 Maestro Reference Database Study II
Study Details
Study Description
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%.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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%.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Normal Eyes Subjects with no known ocular diseases will be scanned with the Maestro device |
Device: 3D OCT-1 Maestro
OCT machines used for diagnostic purposes
|
Outcome Measures
Primary Outcome Measures
- Retinal Thickness [1 minute]
Eligibility Criteria
Criteria
Inclusion Criteria for Normal Group
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Subjects 18 years of age or older on the date of informed consent
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Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
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Subjects presenting at the site with normal eyes (eyes without pathology)
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lOP <= 21 mmHg bilaterally
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BCVA 20/40 or better (each eye)
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Both eyes must be free of eye disease
Exclusion Criteria for Normal Group
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Subjects previously enrolled in either the Maestro AP study or the Maestro2 study
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Subjects unable to tolerate ophthalmic imaging
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Subject with ocular media not sufficiently clear to obtain acceptable OCT images
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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%
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Visual field defects consistent with glaucomatous optic nerve damage based on with at least one of the following two findings:
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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;
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Glaucoma hemi-field test "outside normal limits."
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Presence of any ocular pathology except for cataract
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Narrow angle
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History of leukemia, dementia or multiple sclerosis
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Concomitant use of hydroxychloroquine and chloroquine
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UAB School of Optometry | Birmingham | Alabama | United States | 35233 |
| 2 | Southern California College of Optometry | Fullerton | California | United States | 92831 |
| 3 | Valley Eyecare Center | Livermore | California | United States | 94550 |
| 4 | Western University of Health Sciences | Pomona | California | United States | 91716 |
| 5 | Illinois College of Optometry | Chicago | Illinois | United States | 60616 |
| 6 | New York VA | Jamaica | New York | United States | 11425 |
| 7 | SUNY College of Optometry | New York | New York | United States | 10036 |
Sponsors and Collaborators
- Topcon Medical Systems, Inc.
Investigators
- Study Chair: Charles Reisman, MS, Topcon Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Maestro_NDB_II