P200TE Agreement and Precision Study

NCT05536401 | Terminated FDA Device

• 1 other identifier: OPT1060
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retina Disease; Glaucoma; Normal

Outcome Measures

Primary Outcomes (8)

• Limit of Agreement (LOA) between the P200TE and predicate device measurements of full retinal thickness.

  1 year

• Limit of Agreement (LOA) between the P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm).

  1 year

• Limit of Agreement (LOA) between the P200TE and predicate device measurements of ganglion cell complex thickness (μm).

  1 year

• Limit of Agreement (LOA) between the P200TE and predicate device measurements of optic disc (disc area, rim area, cup-to-disc area, cup-to-disc vertical, cup-to-disc horizontal)

  1 year

• Precision between the P200TE and predicate device measurements of full retinal thickness.

  1 year

• Precision between the P200TE and predicate device measurements of retinal nerve fiber layer thickness.

  1 year

• Precision between the P200TE and predicate device measurements of ganglion cell complex thickness

  1 year

• Precision between the P200TE and predicate device measurements of optic disc (disc area, rim area, cup-to-disc area, cup-to-disc vertical, cup-to-disc horizontal)

  1 year

Study Arms (1)

Optical Coherence Tomography (OCT)

OTHER

Device: P200TE; Device: Predicate Device

Interventions

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 not able to obtain acceptable OCT images due to ocular media opacity or other reasons
• Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
• Presence of any ocular pathology except for cataract in either eye
• 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 year 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 not able to obtain acceptable OCT images due to ocular media opacity or other reasons

Sponsors & Collaborators

• Optos, PLC: lead

Study Sites (1)

Illinois College of Optometry

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

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: September 7, 2022
• First Posted: September 10, 2022
• Study Start: September 2, 2022
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)