Eyes With Retinal Diseases, Glaucomatous Eyes, Normal Healthy Subjects With No Known Ocular Diseases
Conditions
Brief summary
Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, Full Retinal Thickness, and Ganglion Cell Thickness between the Maestro and iVue OCT devices.
Interventions
DEVICE3D OCT-1 Maestro
OCT machines used for diagnostic purposes
DEVICEiVue
OCT machines used for diagnostic purposes
Sponsors
Topcon Medical Systems, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 with at least one of the following two findings: 1. 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; 2. 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 Inclusion Criteria for Glaucoma 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. BCVA 20/40 or better in the study eye 4. Visual field defects consistent with glaucomatous optic nerve damage based on with at least one of the following two findings: 1. 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; 2. Glaucoma hemi-field test outside normal limits. 5. Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities: 1. Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; 2. Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or 3. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optic Disc Measurements (Optic Disc/Cup Size) | 1 Hour | Reporting of the Optic Disc Size and Cup Size |
| Retinal Nerve Fiber Layer (RNFL) Thickness Measurements At Different Clock Hours | 1 Hour | RNFL thickness measured at different clock hours |
| Full Retinal Thickness Measurements | 1 Hour | Full Retinal Thicknesses measured in different quadrants of the scan |
| Ganglion Cell Thickness Measurements | 1 Hour | Ganglion Cell Thickness measured in different quadrants of the scan |
Countries
United States
Outcome results
None listed