CClinicalTrials.gg
CompletedNCT01510392Updated Apr 12, 2018

CEI Van Outreach Screening Study

An observational study in Glaucoma, Macular Disease and Keratoconus, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-12.

Sponsored by Oregon Health and Science University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
118
Ages
18 Years to 89 Years
Sex
All
01

Study summary

The primary goal of the trial is to show that optical coherence tomography (OCT) technology can be used to effectively screen for diseases of the eye including glaucoma, macular diseases and keratoconus. Glaucoma is a disease that causes permanent vision loss and is usually accompanied by increased eye pressure. Macular diseases affect sharp, central vision. Keratoconus is a disease that affects the cornea (clear surface covering the colored part of the eye).

Read the detailed description

The identification of many eye diseases would significantly benefit from earlier detection than is available with typical eye exams. Optical coherence tomography (OCT) is an imaging technology that can perform non-contact cross-sectional imaging of tissue structure in real time. It is similar to ultrasound B-mode imaging, except that OCT measures the intensity of reflected light rather than sound waves.

02

Conditions studied

  • Glaucoma
  • Macular Disease
  • Keratoconus

Keywords

  • Optical coherence tomography
  • Glaucoma
  • Macula
  • Keratoconus
  • Screening
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 118 is above the median of 103 across 454 observational studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

This study will be performed enrolling participants from the Casey Eye Institute outreach van.

Inclusion criteria

  • Participant undergoing a screening examination at the Casey Eye Institute Outreach Van.
  • Participants must be between the ages of 18 and 89 years old.

Exclusion criteria

Exclusion Criteria:

  • Inability to give informed consent.
  • Inability to maintain stable fixation for OCT imaging
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
118 participants (actual)

Interventions

  • DeviceOCT imaging, the FDA Cleared iVue

    The OCT system scans a beam of light across the eye to take a picture. OCT imaging does not touch the eye. This is a test that is performed using an FDA approved system, and is regularly used to take pictures of the back of the eye.

06

What researchers measure

Primary outcomes

  1. OCT screening efficacy for detection of early stage eye diseases in comparison to the current standard of care methods

    The primary goal of the trial is to show that OCT technology, specifically the FDA cleared iVue, can be used to effectively screen for glaucoma, macular diseases and keratoconus. The rate of detection of these diseases detected using OCT will be compared to the rate of detection by the physician's exam.

    Time frame: 1 year

07

Study locations

1 site
  • Casey Eye Institute Outreach Screening Van
    Portland, Oregon 97239, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01510392
Lead sponsor
Oregon Health and Science University
Collaborators
National Eye Institute (NEI)
Responsible party
David Huang (Michael Chiang, MD, Professor, Provisional, Department of Ophthalmology and Medical Informatics & Clinical Epidemiology, Oregon Health and Science University) — Principal investigator
First posted
Jan 16, 2012
Start date
Jan 2012
Primary completion
Feb 2, 2017
Completion
Feb 2, 2017
Last update
Apr 12, 2018

Study contacts

Michael Chiang, MD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion