Topcon 3D OCT-1 Maestro Reference Database Study II

Topcon

Status: Completed

Conditions: Healthy

Treatments: Device: 3D OCT-1 Maestro

Study type: Observational

Funder types: Industry

Identifiers

NCT02447120

Maestro_NDB_II

Details and patient eligibility

About

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%.

Full 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%.

Enrollment: 504 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

504 participants in 1 patient group

Normal Eyes

Description:

Subjects with no known ocular diseases will be scanned with the Maestro device

Treatment:

Device: 3D OCT-1 Maestro