Glaucoma, Healthy, Retinal Disease
Conditions
Brief summary
This study is a prospective comparative study to gather pilot agreement and precision data in normal subjects, subjects with glaucoma, and subjects with retinal disease.
Interventions
DEVICEKOWA OCT Bi-µ
Non-contact, ultra-high resolution ophthalmic imaging system for fundus imaging and axial cross-sectional and three-dimensional imaging of retinal structures.
DEVICEOptovue iVue 100
U.S. Food and Drug Administration (FDA) cleared and commercially available Optovue iVue 100
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Eligible participants assigned two interventions under random sequence assignments.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
(Normal Group): * Subjects with normal eye examinations (without pathology other than cataract) in one or both eyes on the date of the study visit; * Subjects with intraocular pressure (IOP) ≤ 21 mmHg in the normal eye(s) on the date of the study visit; and * Subjects with current best-spectacle-corrected visual acuity (BSCVA) of 20/40 or better in the normal eye(s) on the date the study visit.
Exclusion criteria
(Normal Group): * Subjects unable to tolerate ophthalmic imaging; * Subjects with ocular media not sufficiently clear to obtain acceptable OCT images; * Subjects with any current ocular pathology other than cataract in the normal eye(s), as determined by self-report and/or investigator assessment at the study visit; * Subjects with current narrow anterior chamber drainage angle in the normal eye(s), as determined by self-report and/or investigator assessment at the study visit; and * Subjects with a history of leukemia, dementia or multiple sclerosis. Inclusion Criteria (Glaucoma Group): * Subjects who have been diagnosed with glaucoma in the glaucoma study eye(s), with optic nerve damage as evidenced by either of the following optic disc or retinal nerve fiber layer structural abnormalities observed via fundus exam during the study visit: 1. Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; or 2. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue; * Subjects with a current BSCVA of 20/40 or better in the glaucoma study eye(s) on the date of the visit; and * History of visual field defects within the previous two (2) months from the study visit or measured on the day of the study visit that is consistent with glaucomatous optic nerve damage based on at least one of the following 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; and 2. Glaucoma hemi-field test outside normal limits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare KOWA OCT Bi-μ and Optovue iVue 100 | 1-2 days | 1. Full retinal thickness \[Early Treatment Diabetic Retinopathy Study (ETDRS) Grid\] 2. Full retinal thickness (Manual Measurement) 3. Retinal nerve fiber layer thickness 4. Ganglion cell complex thickness 5. Full retinal thickness map |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Evaluate any adverse events found during the clinical study | 1-2 days | Evaluate any adverse events found during the clinical study |
Countries
United States
Outcome results
None listed