Clinical trial NCT02447120: Topcon 3D OCT-1 Maestro Reference Database Study II
Official title: Topcon 3D OCT-1 Maestro Reference Database Study II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Volunteers with Healthy Eyes
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2015-05-18
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects without eye disease

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%.

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%.

Eligibility criteria: 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

Primary outcomes:
measure: Retinal Thickness
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB School of Optometry
state: Alabama
city: Fullerton
country: United States
facility: Southern California College of Optometry
state: California
city: Livermore
country: United States
facility: Valley Eyecare Center
state: California
city: Pomona
country: United States
facility: Western University of Health Sciences
state: California
city: Chicago
country: United States
facility: Illinois College of Optometry
state: Illinois
city: Jamaica
country: United States
facility: New York VA
state: New York
city: New York
country: United States
facility: SUNY College of Optometry
state: New York
Study officials:
affiliation: Topcon Corporation
name: Charles Reisman, MS
role: STUDY_CHAIR
References: