Performance Evaluation of OCT and OCT Angiography-based Ocular Measurements (Optical Coherence Tomography)
Sponsor
Optovue (Industry)
Overall Status
Completed
CT.gov ID
NCT04437082
Collaborator
(none)
143
1
3.4
41.5
Study Details
Study Description
Brief Summary
The purpose of this study is to assess performance of measurements of anatomical and vascular structures of the eye based on OCT and OCTA scans in normal subjects and eyes with pathology.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
143 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Performance Evaluation of OCT and OCTA-based Ocular Measurements
Actual Study Start Date
:
Jan 15, 2021
Actual Primary Completion Date
:
Apr 30, 2021
Actual Study Completion Date
:
Apr 30, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Normal no pre-existing conditions |
Device: optical coherence tomography
imaging structural and vascular features of the eye
|
| Glaucoma diagnosis of glaucoma |
Device: optical coherence tomography
imaging structural and vascular features of the eye
|
| Retina diagnosis of retina pathology |
Device: optical coherence tomography
imaging structural and vascular features of the eye
|
| Cornea diagnosis of corneal condition |
Device: optical coherence tomography
imaging structural and vascular features of the eye
|
Outcome Measures
Primary Outcome Measures
- Standard Deviation [Day 1]
measure of variance
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Normal - No pre-existing conditions.
-
Glaucoma - Diagnosis of glaucoma.
-
Retina - Diagnosis of retinal pathology
-
Cornea - Diagnosis of clinic condition.
Exclusion Criteria:
- Unable to complete required exams.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oklahoma College of Optometry, Northeastern State University | Tahlequah | Oklahoma | United States | 74464 |
Sponsors and Collaborators
- Optovue
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Optovue
ClinicalTrials.gov Identifier:
NCT04437082
Other Study ID Numbers:
- 200-54611
First Posted:
Jun 18, 2020
Last Update Posted:
Sep 20, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No