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CompletedNCT01242553Updated Sep 28, 2017

Clinical Validation Study for iVue

An observational study in Normal and Ocular Pathology, sponsored by Optovue. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-28.

Sponsored by Optovue · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
48
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To demonstrate clinical substantial equivalence of iVue as comparable to commercially available RTVue.

02

Conditions studied

  • Normal and Ocular Pathology
03

In context

Lead sponsor

Optovue is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Volunteers with various ocular pathology or no ocular pathology.

Eligibility criteria

Inclusion Criteria:

  • Normal: Normal results from clinical exam and free of ocular pathology.
  • Glaucoma: Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
  • Cornea: Clinical exam results consistent with cornea pathology.
  • Retina: Clinical exam results consistent with retina pathology
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
48 participants (actual)

Groups and cohorts

  • Normal

    Normal results from clinical exam and free of ocular pathology.

  • Retina

    Clinical exam results consistent with retina pathology

  • Glaucoma

    Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.

  • Cornea

    Clinical exam results consistent with cornea pathology.

06

What researchers measure

Primary outcomes

  1. thickness of ocular structures

07

Study locations

2 sites
  • Pacific Eye Specialists
    Daly City, California 94015, United States
  • Colorado Retina Center
    Denver, Colorado 80204, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01242553
Lead sponsor
Optovue
First posted
Nov 17, 2010
Start date
Oct 2009
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Sep 28, 2017

Study contacts

Michael Hee, MD
principal investigator · Pacific Eye Specialists
Nalin Mehta, MD
principal investigator · Colorado Retina Center
Michael Sinai, PhD
study director · Optovue

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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