GlaucomaNCT01510392
CEI Van Outreach Screening Study
An observational study of Glaucoma and Macular Disease, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Macular Disease, Keratoconus
- What is being tested?
- OCT imaging, the FDA Cleared iVue
- Type of treatment
- Medical device
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 2 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will be performed enrolling participants from the Casey Eye Institute outreach van.
Who may be able to join
- Participant undergoing a screening examination at the Casey Eye Institute Outreach Van.
- Participants must be between the ages of 18 and 89 years old.
Who cannot join
- Inability to give informed consent.
- Inability to maintain stable fixation for OCT imaging
Trial locations and contacts
1 site in 1 country.
United States1 site
Casey Eye Institute Outreach Screening Van
Portland, Oregon, 97239
About this study
Official title: Prospective Evaluation of Optical Coherence Tomography Usage in the Screening of Eye Diseases
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.
- Conditions
- Glaucoma, Macular Disease, Keratoconus
- Being tested
- OCT imaging, the FDA Cleared iVue
- Keywords
- Optical coherence tomography, Glaucoma, Macula, Keratoconus, Screening
- Medical subject headings
- Glaucoma, Macular Degeneration, Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT imaging, the FDA Cleared iVueDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJan 2012
- Primary completion2 Feb 2017
- Study completion2 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, David Huang, Oregon Health and Science University
- Investigators
- Michael Chiang, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510392
- Sponsor's protocol ID
- OHSU IRB#00008034-Outreach
- Status last verified
- Apr 2018
- First submitted
- 3 Jan 2012
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Optical Coherence Tomography Usage in the Screening of Eye Diseases
- ClinicalTrials.gov ID
- NCT01510392
- Acronym / sponsor ID
- OHSU IRB#00008034-Outreach
- Conditions
- Glaucoma, Macular Disease, Keratoconus
- Keywords
- Optical coherence tomography, Glaucoma, Macula, Keratoconus, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Jan 2012
- Primary completion
- 2 Feb 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 16 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be performed enrolling participants from the Casey Eye Institute outreach van.
Key inclusion criteria (2 listed)
- Participant undergoing a screening examination at the Casey Eye Institute Outreach Van.
- Participants must be between the ages of 18 and 89 years old.
Key exclusion criteria (2 listed)
- Inability to give informed consent.
- Inability to maintain stable fixation for OCT imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT imaging, the FDA Cleared iVueThe 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. | Device | – |
Primary outcome
OCT screening efficacy for detection of early stage eye diseases in comparison to the current standard of care methods
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Chiang, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Macular Disease, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCT screening efficacy for detection of early stage eye diseases in comparison to the current standard of care methods (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.