Comparison of OCT and OCTA-based Ocular Measurements to Those of Predicate

Completed

• Conditions: Normal Eyes and Eyes With Ocular Pathologies
• Interventions: Device: SD-OCT

• Registration Number: NCT03852485
• Lead Sponsor: Optovue

Brief Summary

Comparison of OCT and OCTA-based Ocular Measurements to those of Predicate

Detailed Description

The purpose of this study is to compare with predicate device for the measurements of vascular structures and anatomical structures of the posterior pole of the eye based on OCTA and OCT scans in normal subjects, glaucoma patients, and retina patients, and to compare with predicate device for the measurements of corneal layers based on corneal OCT scans in normal subjects and cornea patients.

Study Timeline

• Study Start: 2019-01-29
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-25
• Status Verified: 2019-08
• Primary Completion: 2019-08-02
• Study Completion: 2019-08-30
• Last Update Submitted: 2019-08-30
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

• Normal - No glaucoma or treatment to lower IOP or retinal pathology for posterior imaging; No contact lens wear, dry eye, anterior pathology or ocular surgery for corneal imaging.
• Glaucoma - Have glaucoma and no history of other retinal pathology.
• Retina - Have retinal pathology and no history of glaucoma or treatment to lower IOP.
• Cornea - Contact lens wear or corneal condition such as dry eye, KCN, or post refractive surgery.

Exclusion Criteria

• Normal - Unable to complete required exams; Clinical finding of posterior pathology or VA worse than 20/40 for posterior imaging; Clinical findings of corneal condition for corneal imaging.
• Glaucoma - Unable to complete required exams; Clinical signs of retinal pathology.
• Retina - Unable to complete required exams.
• Cornea - Unable to complete required exams.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glaucoma	SD-OCT	diagnosis of glaucoma
Retina	SD-OCT	diagnosis of AMD, DR or other retinal pathology
Cornea	SD-OCT	wear contact lens or prior refractive surgery or having dry eye or KCN
Normal	SD-OCT	no glaucoma or retinal pathology or corneal conditions

Primary Outcome Measures

Name	Time	Method
Limits of agreement	Day 1	estimation of the interval within which a proportion of the differences between measurements lie

Secondary Outcome Measures

Name	Time	Method
Regression Analysis	Day 1	statistical process for estimating the relationships among variables

Trial Locations

Locations (2)

AMA; 🇺🇸 Marysville, Ohio, United States

IOVS; 🇺🇸 Newark, New Jersey, United States