NCT03852485

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 29, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

February 21, 2019

Last Update Submit

August 30, 2019

Conditions

Normal Eyes and Eyes With Ocular Pathologies

Outcome Measures

Primary Outcomes (1)

  • Limits of agreement

    estimation of the interval within which a proportion of the differences between measurements lie

    Day 1

Secondary Outcomes (1)

  • Regression Analysis

    Day 1

Study Arms (4)

Normal

no glaucoma or retinal pathology or corneal conditions

Device: SD-OCT

Glaucoma

diagnosis of glaucoma

Device: SD-OCT

Retina

diagnosis of AMD, DR or other retinal pathology

Device: SD-OCT

Cornea

wear contact lens or prior refractive surgery or having dry eye or KCN

Device: SD-OCT

Interventions

SD-OCTDEVICE

Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures

CorneaGlaucomaNormalRetina

Eligibility Criteria

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

Seeing eye doctor for routine care

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IOVS

Newark, New Jersey, 07103, United States

Location

AMA

Marysville, Ohio, 43040, United States

Location

Study Design

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

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 25, 2019

Study Start

January 29, 2019

Primary Completion

August 2, 2019

Study Completion

August 30, 2019

Last Updated

September 3, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)