Evaluation of the Repeatability and Reproducibility of AngioVue

Completed

• Conditions: Normal, Glaucoma & Retinal Pathology
• Interventions: Device: Optical Coherence Tomography Angiography

• Registration Number: NCT02911883
• Lead Sponsor: Optovue

Brief Summary

The purpose of this study is to assess the repeatability and reproducibility of measurements of the vascular structures and the anatomical structures of the posterior pole of the eye based on AngioVue volume scans in normal subjects, glaucoma patients, and retina patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-29
• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-22
• Primary Completion: 2017-02-01
• Study Completion: 2017-02-02
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Normal

   • Age > 18.
   • No retinal pathology or glaucoma.

2. Glaucoma patient

   • Age > 18.
   • Have glaucoma.

3. Retina patient

   • Age > 18.
   • Have retina pathology.

Exclusion Criteria

1. Normal

   • Unable to complete required exams.
   • Poor quality image data.

2. Glaucoma patient

   • Unable to complete required exams.
   • Poor quality image data.
   • Retinal pathology.

3. Retina patient

   • Unable to complete required exams.
   • Poor quality image data.
   • Glaucoma.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal	Optical Coherence Tomography Angiography	Not having glaucoma or retinal pathology
Glaucoma	Optical Coherence Tomography Angiography	Having glaucoma.
Retina	Optical Coherence Tomography Angiography	Having retinal pathology

Primary Outcome Measures

Name	Time	Method
Retina vasculature	Day 1