Precision of OCT and OCTA-based Ocular Measurements

Completed

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

• Registration Number: NCT03859310
• Lead Sponsor: Optovue

Brief Summary

Precision of OCT- and OCTA-based Ocular Measurements

Detailed Description

The purpose of this study is to assess precision of measurements of vascular structures and the 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 assess 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: 2019-02-22
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-03-01
• Primary Completion: 2019-07-10
• Status Verified: 2019-08
• 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: 144

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
Normal	SD-OCT	no glaucoma or retinal pathology or corneal conditions
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
Glaucoma	SD-OCT	diagnosis of glaucoma

Primary Outcome Measures

Name	Time	Method
Repeatability and Reproducibility Standard Deviation of ocular measurements	Day 1	calculated value minus the measured value

Secondary Outcome Measures

Name	Time	Method
Repeatability and Reproducibility Coefficient of Variation of ocular measurements	Day 1	maximum difference that is likely to occur between repeated measurements

Trial Locations

Locations (1)

AMA; 🇺🇸 Marysville, Ohio, United States