GlaucomaNCT00556114
A Pilot Study of Functional Optical Coherence Tomography for Ocular Imaging
An observational study of Glaucoma and Diabetic Retinopathy, run by University of California, Irvine at 1 site in United States.
Trial summary
Growing evidence shows that altered blood flow plays a major role in many vision-threatening diseases including glaucoma, diabetic retinopathy, age-related macular degeneration, Central Retinal Vein Occlusion, and Branch Retinal Vein Occlusion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Diabetic Retinopathy, Age-Related Macular Degeneration
- What is being tested?
- Optical Coherence Tomography
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jul 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic and community sample.
Who may be able to join
- Adult 18 years and older with normal eye, or has been diagnosed with eye disease.
Who cannot join
- Less than 18 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Institute, University of California,Irvine
Irvine, California, 02612
About this study
Growing evidence shows that altered blood flow plays a major role in many vision-threatening diseases including glaucoma, diabetic retinopathy, age-related macular degeneration, Central Retinal Vein Occlusion, and Branch Retinal Vein Occlusion. Optical coherence tomography, an established imaging technique use for eye exam in clinical ophthalmology, provides high-resolution cross sectional images of the retina and has increased our ability to understand many eye diseases.
Read the detailed description
Optical Coherence Tomography is a non-invasive technique use a broadband light source to illuminate the area of study with light in the near infrared spectrum, then obtains static images of tissue structure from interference signals of the back-reflected light.
Optical Coherence Tomography a non-contact, non-invasive means of documenting both tissue structure and blood flow changes in ocular disease and can provide high resolution cross-sectional images of tissue structure, direct visualization of blood flow in blood vessels of the eye.
- Conditions
- Glaucoma, Diabetic Retinopathy, Age-Related Macular Degeneration, Central Retinal Vein Occlusion, Branch Retinal Vein Occlusion
- Being tested
- Optical Coherence Tomography
- Keywords
- eye exam, Retina
- Medical subject headings
- Glaucoma, Diabetic Retinopathy, Macular Degeneration, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyDevice
Optical Coherence Tomography
| Study group | Role | What they receive |
|---|---|---|
| Optical Coherence Tomography | Optical Coherence Tomography Receives: Device: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical exam tool
Optical Coherence Tomography imaging technique of the retina and ability to diagnose and manage many eye diseases
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startJan 2007
- Primary completionJul 2013
- Study completionJul 2013
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Baruch D Kuppermann,, M.D., Ph.D., Principal investigator, Ophthamology, University of California,IrvineZhongping Chen, Ph,D, Principal investigator, Beckman Laser Institute University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556114
- Sponsor's protocol ID
- 20043555
- Status last verified
- Oct 2022
- First submitted
- 7 Nov 2007
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Functional Optical Coherence Tomography for Ocular Imaging
- ClinicalTrials.gov ID
- NCT00556114
- Acronym / sponsor ID
- 20043555
- Conditions
- Glaucoma, Diabetic Retinopathy, Age-Related Macular Degeneration, Central Retinal Vein Occlusion, Branch Retinal Vein Occlusion
- Keywords
- eye exam, Retina
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Jan 2007
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 9 Nov 2007 (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.
Growing evidence shows that altered blood flow plays a major role in many vision-threatening diseases including glaucoma, diabetic retinopathy, age-related macular degeneration, Central Retinal Vein Occlusion, and Branch Retinal Vein Occlusion. Optical coherence tomography, an established imaging technique use for eye exam in clinical ophthalmology, provides high-resolution cross sectional images of the retina and has increased our ability to understand many eye diseases.
Detailed description
Optical Coherence Tomography is a non-invasive technique use a broadband light source to illuminate the area of study with light in the near infrared spectrum, then obtains static images of tissue structure from interference signals of the back-reflected light.
Optical Coherence Tomography a non-contact, non-invasive means of documenting both tissue structure and blood flow changes in ocular disease and can provide high resolution cross-sectional images of tissue structure, direct visualization of blood flow in blood vessels of the eye.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical Coherence Tomography | – | Device: Optical Coherence TomographyOptical Coherence Tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic and community sample.
Key inclusion criteria (1 listed)
- Adult 18 years and older with normal eye, or has been diagnosed with eye disease.
Key exclusion criteria (1 listed)
- Less than 18 years of age.
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 |
|---|---|---|
| Optical Coherence TomographyOptical Coherence Tomography | Device | Optical Coherence Tomography |
Primary outcome
Medical exam tool
Time frame: 24 hours
Optical Coherence Tomography imaging technique of the retina and ability to diagnose and manage many eye diseases
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 20 Oct 2022.
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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.
Baruch D Kuppermann,, M.D., Ph.D. principal investigator
Ophthamology, University of California,Irvine
Zhongping Chen, Ph,D principal investigator
Beckman Laser Institute University of California Irvine
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 Diabetic Retinopathy, run by University of California, Irvine 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 1 inclusion and 1 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 20 Oct 2022. 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?
Medical exam tool (time frame: 24 hours). 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 20 Oct 2022.