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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1
IOVS
Newark, New Jersey, United States, 07103
2
AMA
Marysville, Ohio, United States, 43040