NCT01986478CompletedNot Applicable
Topcon 3D OCT-1 Maestro and 3D OCT-2000 Optical Coherence Tomography Systems: Reference Database Study
Topcon Medical Systems, Inc.5 sites in 1 country389 target enrollmentStarted: October 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Topcon Medical Systems, Inc.
- Enrollment
- 389
- Locations
- 5
- Primary Endpoint
- Retinal Thickness
Study Overview
Brief Summary
To collect data for a reference database.
Detailed Description
Collection of multiple subjects to create a reference database.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects 18 years of age or older on the date of informed consent
- •Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- •Subjects presenting at the site with normal eyes (eyes without pathology)
- •IOP ≤ 21 mmHg bilaterally
- •BCVA 20/40 or better (each eye)
- •Both eyes must be free of eye disease
Exclusion Criteria
- •Subjects unable to tolerate ophthalmic imaging
- •Subject with ocular media not sufficiently clear to obtain acceptable OCT images
- •HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD < 5%
- •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%
- •Presence of any ocular pathology except for cataract
- •Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning
- •Narrow angle
- •History of leukemia, dementia or multiple sclerosis
- •Concomitant use of hydroxychloroquine and chloroquine
Outcomes
Primary Outcomes
Retinal Thickness
Time Frame: Day 1
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (5)
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