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

Optovue

Status

Completed

Conditions

Normal Eyes and Eyes With Ocular Pathologies

Treatments

Device: SD-OCT

Study type

Observational

Funder types

Industry

Identifiers

NCT03852485

200-53769

Details and patient eligibility

About

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

Full 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.

Enrollment

199 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

IInclusion 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.