Triton Agreement and Precision Study

Launched by TOPCON MEDICAL SYSTEMS, INC. · Mar 9, 2017

Keywords

ClinConnect Summary

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.

Gender

ALL

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 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
• • Exclusion Criteria for Glaucoma Group
• • 1. Subjects unable to tolerate ophthalmic imaging
• • 2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
• • 3. HFA visual field (24-2 Sita Standard, white on white) result unreliable, defined as fixation losses \> 20% or false positives \> 33%, or false negatives \> 33% in the study eye
• • 4. Presence of any ocular pathology except glaucoma in the study eye (cataracts are acceptable)
• • 5. History of leukemia, dementia or multiple sclerosis
• • 6. Concomitant use of hydroxychloroquine and chloroquine
• • Inclusion Criteria for Retina Disease 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 retinal disease
• • 4. IOP ≤ 21 mmHg in the study eye
• • 5. BCVA 20/400 or better in the study eye
• • 6. Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Cystoid Macula Edema, and others
• • Exclusion Criteria for Retinal Disease Group
• • 1. Subjects unable to tolerate ophthalmic imaging
• • 2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
• • 3. Presence of glaucoma or any ocular pathology other than a Retinal pathology (e.g., cornea pathology) in the study eye (cataracts are acceptable)
• • 4. Narrow angle in the study eye
• • 5. History of leukemia, dementia or multiple sclerosis
• • 6. Concomitant use of hydroxychloroquine and chloroquine

Trial Officials