Optos P200TE Agreement and Precision Study

Not Applicable

Completed

• Conditions: Glaucoma; Retinal Disease
• Interventions: Device: Optos P200TE; Device: Predicate Device

• Registration Number: NCT03868462
• Lead Sponsor: Optos, PLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-11
• Study First Submitted: 2019-03-02
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-11
• Primary Completion: 2019-09-16
• Study Completion: 2019-09-16
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-13
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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)	Optos P200TE	-
Optical Coherence Tomography (OCT)	Predicate Device	-

Primary Outcome Measures

Name	Time	Method
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 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 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)
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 ganglion cell complex thickness (μm).	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)
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)
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)
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 retinal nerve fiber layer 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 full retinal thickness.	At the end of Visit 1 or optional Visit 2 (each visit is 1 day)

Trial Locations

Locations (1)

New England Retina Consultants; 🇺🇸 Springfield, Massachusetts, United States