P200TE and Predicate Agreement and Precision Study

Not Applicable

Recruiting

• Conditions: Glaucoma; Normal; Retina Disease
• Interventions: Device: P200TE; Device: Predicate

• Registration Number: NCT05624593
• Lead Sponsor: Optos, PLC

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-04
• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-14
• Last Update Submitted: 2022-11-14
• Study First Posted: 2022-11-22
• Last Update Posted: 2022-11-22
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optical Coherence Tomography (OCT)	Predicate	-
Optical Coherence Tomography (OCT)	P200TE	-

Primary Outcome Measures

Name	Time	Method
Limit of Agreement (LOA) between the P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm).	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
Precision between the P200TE and predicate device measurements of ganglion cell complex thickness	1 year
Precision between the P200TE and predicate device measurements of retinal nerve fiber layer thickness.	1 year
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 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

Trial Locations

Locations (1)

Illinois College of Optometry; 🇺🇸 Chicago, Illinois, United States