Status:

COMPLETED

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

Lead Sponsor:

Optovue

Conditions:

Normal Eyes and Eyes With Ocular Pathologies

Eligibility:

All Genders

18+ years

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 norm...

Eligibility Criteria

Inclusion

  • I
  • 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

  • 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.

Key Trial Info

Start Date :

January 29 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 30 2019

Estimated Enrollment :

199 Patients enrolled

Trial Details

Trial ID

NCT03852485

Start Date

January 29 2019

End Date

August 30 2019

Last Update

September 3 2019

Active Locations (2)

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Page 1 of 1 (2 locations)

1

IOVS

Newark, New Jersey, United States, 07103

2

AMA

Marysville, Ohio, United States, 43040