Optos P200TE Agreement and Precision Study

Glaucoma Clinical Trial

Official title:

Optos P200TE Agreement and Precision Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868462
• Other study ID #: OPT1029
• Status: Completed
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: September 16, 2019

Study information

• Verified date: October 2019
• Source: Optos, PLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: September 16, 2019
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Retinal Disease
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
United States	New England Retina Consultants	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Optos, PLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of full retinal thickness (µm).		At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Primary	Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of retinal nerve fiber layer thickness (µm).		At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Primary	Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of ganglion cell complex thickness (µm).		At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Primary	Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of optic disc (area, volume, cup-to-disc ratio).		At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Primary	Precision between the Optos P200TE and predicate device measurements of full retinal thickness.		At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Primary	Precision between the Optos P200TE and predicate device measurements of retinal nerve fiber layer thickness.		At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Primary	Precision between the Optos P200TE and predicate device measurements of ganglion cell complex thickness.		At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Primary	Precision between the Optos P200TE and predicate device measurements of optic disc (area, volume, cup-to-disc ratio).		At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Primary	Precision of the P200TE for the super pixel grid measurements of the full retinal thickness.		At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Primary	Precision of the P200TE for the super pixel grid measurements of the RNFL thickness.		At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Primary	Precision of the P200TE for the super pixel grid measurements of GCC thickness.		At the end of Visit 1 or optional Visit 2 (each visit is 1 day)