Eye Diseases, Healthy Eyes
Conditions
Keywords
no known ocular pathology, Glaucoma, Retinal Disease
Brief summary
To Compare the agreement and precision between the Topcon DRI OCT Triton and the 3D OCT-1 Maestro with RDB.
Detailed description
The objectives of this study are to compare the agreement and precision between Topcon DRI OCT Triton and 3D OCT-1 Maestro with RDB by measuring the thickness layers.
Interventions
The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes
DEVICE3D OCT-1 Maestro
The 3D OCT-1 Maestro is an OCT machine 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 bilaterally (cataracts are acceptable) 4. IOP ≤ 21 mmHg bilaterally 5. BCVA 20/40 or better bilaterally
Exclusion criteria
for Normal Group 1. Subjects unable to tolerate ophthalmic imaging 2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images 3. 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% 4. Visual field defects consistent with glaucomatous optic nerve damage based on 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. Narrow angle 6. History of leukemia, dementia or multiple sclerosis 7. 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 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 |
|---|---|---|
| Retinal Thickness | 1 Minute | The thickness of the macula layer |
Countries
United States
Outcome results
None listed