OCT Reference Database

Completed

• Conditions: Healthy

• Registration Number: NCT01986478
• Lead Sponsor: Topcon Medical Systems, Inc.

Brief Summary

To collect data for a reference database.

Detailed Description

Collection of multiple subjects to create a reference database.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-15
• Study First Posted: 2013-11-18
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retinal Thickness	Day 1

Trial Locations

Locations (5)

Valley Eyecare Center; 🇺🇸 Livermore, California, United States

Keck School of Medicine; 🇺🇸 Los Angeles, California, United States

Horizon Eye Specialist & Laser Center; 🇺🇸 Scottsdale, Arizona, United States

Western University of Health Sciences; 🇺🇸 Pomona, California, United States

Stat University of New York College of Optometry; 🇺🇸 New York, New York, United States