NCT04437082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

September 20, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

June 15, 2020

Last Update Submit

September 13, 2021

Conditions

Normal Eyes and Ocular Pathology

Outcome Measures

Primary Outcomes (1)

  • Standard Deviation

    measure of variance

    Day 1

Study Arms (4)

Normal

no pre-existing conditions

Device: optical coherence tomography

Glaucoma

diagnosis of glaucoma

Device: optical coherence tomography

Retina

diagnosis of retina pathology

Device: optical coherence tomography

Cornea

diagnosis of corneal condition

Device: optical coherence tomography

Interventions

optical coherence tomographyDEVICE

imaging structural and vascular features of the eye

CorneaGlaucomaNormalRetina

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Seeing eye doctor for routine or follow-up care

You may qualify if:

  • Normal - No pre-existing conditions.
  • Glaucoma - Diagnosis of glaucoma.
  • Retina - Diagnosis of retinal pathology
  • Cornea - Diagnosis of clinic condition.

You may not qualify if:

  • \- Unable to complete required exams.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma College of Optometry, Northeastern State University

Tahlequah, Oklahoma, 74464, United States

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 18, 2020

Study Start

January 15, 2021

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

September 20, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)