Optos P200TE Agreement and Precision Study

NCT ID: NCT03868462

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-11
• Study Completion Date: 2019-09-16

Brief Summary

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.

Conditions

Retinal Disease; Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Optical Coherence Tomography (OCT)

Group Type: OTHER

Optos P200TE

Intervention Type: DEVICE

The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.

Predicate Device

Intervention Type: DEVICE

The predicate device is an optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior ocular structures.

Interventions

Optos P200TE

The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.

Intervention Type: DEVICE

Predicate Device

The predicate device is an optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior ocular structures.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

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

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

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

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

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Optos, PLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

New England Retina Consultants

Springfield, Massachusetts, United States

Countries

United States

Other Identifiers

OPT1029

Identifier Type: -

Identifier Source: org_study_id