Optos P200TE Agreement and Precision Study

NCT03868462 | Completed FDA Device

• 1 other identifier: OPT1029
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (11)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Optical Coherence Tomography (OCT)

OTHER

Device: Optos P200TE; Device: Predicate Device

Interventions

Optos P200TE DEVICE

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

Optical Coherence Tomography (OCT)

Predicate Device 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.

Optical Coherence Tomography (OCT)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 22 years of age or older on the date of informed consent
• Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
• Subjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens
• BCVA 20/40 or better (each eye) on the date of the study visit

You may not qualify if:

• Subjects unable to tolerate ophthalmic imaging
• Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in either eye
• Presence of any ocular pathology except for cataract in either eye
• History of leukemia, dementia or multiple sclerosis
• Subjects 22 years of age or older on the date of informed consent
• Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
• BCVA 20/40 or better in the study eye
• 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:
• 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;
• Glaucoma hemi-field test "outside normal limits."
• Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
• Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage;
• Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
• Subjects unable to tolerate ophthalmic imaging
• Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye

Sponsors & Collaborators

• Optos, PLC: lead

Study Sites (1)

New England Retina Consultants

Springfield, Massachusetts, 01107, United States

Location

MeSH Terms

Conditions

Retinal Diseases; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases; Ocular Hypertension

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2019
• First Posted: March 11, 2019
• Study Start: February 11, 2019
• Primary Completion: September 16, 2019
• Study Completion: September 16, 2019
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)