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

Normal Eyes and Eyes With Ocular Pathologies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03852485
• Other study ID #: 200-53769
• Status: Completed
• Start date: January 29, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: August 2019
• Source: Optovue
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: August 30, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Normal Eyes and Eyes With Ocular Pathologies

Intervention

Device:
• SD-OCT
Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures

Locations

Country	Name	City	State
United States	AMA	Marysville	Ohio
United States	IOVS	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Optovue

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Limits of agreement	estimation of the interval within which a proportion of the differences between measurements lie	Day 1
Secondary	Regression Analysis	statistical process for estimating the relationships among variables	Day 1