Optos P200TE Agreement and Precision Study

Optos

Status: Completed

Conditions: Glaucoma; Retinal Disease

Treatments: Device: Optos P200TE; Device: Predicate Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT03868462

OPT1029

Details and patient eligibility

About

This study is a prospective comparative, randomized, single center study to assess agreement and precision of the Optos P200TE in comparison to the predicate device in normal subjects, subjects with glaucoma, and subjects with retinal disease.

Enrollment: 137 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Normal Group

1. Subjects 22 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 with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens

4. BCVA 20/40 or better (each eye) on the date of the study visit

   Exclusion Criteria for Normal Group

5. Subjects unable to tolerate ophthalmic imaging

6. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in either eye

7. Presence of any ocular pathology except for cataract in either eye

8. History of leukemia, dementia or multiple sclerosis

   Inclusion Criteria for Glaucoma Group

9. Subjects 22 years of age or older on the date of informed consent

10. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent

11. BCVA 20/40 or better in the study eye

12. History of Visual field defects within the previous six (6) months from the study visit or measured the day of the study visit 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."

13. 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 neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage;
    2. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue

    Exclusion Criteria for Glaucoma Group

14. Subjects unable to tolerate ophthalmic imaging

15. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye

16. No reliable Humphrey Field Analyzer (HFA) visual field (24-2 Sita Standard, white on white) result within 6 months of the study visit, defined as fixation losses > 33% or false positives > 33%, or false negatives > 33% in the study eye

17. Presence of any ocular pathology except glaucoma in the study eye

18. History of leukemia, dementia or multiple sclerosis

    Inclusion Criteria for Retina Disease Group

19. Subjects 22 years of age or older on the date of informed consent

20. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent

21. Subjects presenting at the site with retinal disease

22. BCVA 20/400 or better in the study eye

23. Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration (including patients with drusen and geographic atropy and choroidal neovascularization), Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy and others

    Exclusion Criteria for Retinal Disease Group

24. Subjects unable to tolerate ophthalmic imaging

25. Subject with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye

26. Presence of glaucoma or any ocular pathology other than a retinal pathology (e.g., cornea pathology) in the study eye as determined by self-report and/or investigator assessment at the study visit;

27. History of leukemia, dementia or multiple sclerosis

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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137 participants in 1 patient group

Optical Coherence Tomography (OCT)

Other group

Treatment:

Device: Optos P200TE

Device: Predicate Device