GlaucomaFSOCTNCT01957267
Functional and Structural Imaging for Glaucoma
An observational study of Glaucoma, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The specific aims of the clinical studies are to: Develop a directional high-resolution OCT and OCT angiography prototype to improve imaging of structure and perfusion. Validate wide-field OCT and OCT angiography parameters to improve early glaucoma detection. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- How many people
- 249 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2013to 31 May 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll both males and females and include all ethnic and racial groups through clinical practices in the centers. The study will enroll subjects in the older adult age range commonly affected by glaucoma - 40 years or older. The study will exclude people with life-threatening or debilitating illness that would make 5-year participation unlikely or cooperation with tests difficult. For similar reasons those older than 85 years are excluded. The study also excludes those with any disease that might confound the diagnosis of glaucoma. Otherwise people with any health status are eligible for enrollment. Two groups of participants are recruited in the study: healthy controls or participants with confirmed glaucoma.
Who may be able to join
- ONH or NFL defect visible on slit-lamp biomicroscopy defined as one of following:
- diffuse or localized thinning of the rim
- disc (splinter) hemorrhage
- notch in the rim
- vertical cup/disc ratio greater than the fellow eye by > 0.2
- Presence or absence of VF defects as measured by Humphrey SITA 24-2 VF.
Who cannot join
- Best-corrected visual acuity less than 20/40
- Age < 40 or >85 years
- Refractive error of > +3.00 D or < -7.00 D
- Previous intraocular surgery except for uncomplicated keratorefractive surgery and cataract extraction with posterior chamber intraocular lens implantation
- Diabetic retinopathy
- Other diseases that may cause VF loss or optic disc abnormalities
Show all 10Show fewer
- Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil
- Inability to perform reliably on automated VF testing
- Life-threatening or debilitating illness making it unlikely patient could successfully complete the study.
- Refusal of informed consent or of commitment to the full length of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University, Casey Eye Institute
Portland, Oregon, 97214
Chinmay Deshpande, M.Optom., 503-494-9628, deshpanc@ohsu.edu
Denzil Romfh, OD, 503-494-4351, romfhd@ohsu.edu
About this study
Official title: Longitudinal Observational Study Using Functional and Structural Optical Coherence Tomography to Diagnose and Guide Treatment of Glaucoma
The specific aims of the clinical studies are to:
- Develop a directional high-resolution OCT and OCT angiography prototype to improve imaging of structure and perfusion.
- Validate wide-field OCT and OCT angiography parameters to improve early glaucoma detection.
- Simulate visual field results by combining structural and angiography OCT data.
- Assess abilities of above technologies and OCT-derived parameters on predicting glaucoma detection, conversion, and progression.
Read the detailed description
Glaucoma is the second leading cause of blindness in the US. The diagnosis and monitoring of glaucoma are important problems, not only because of its prevalence, but also because of its silent and irreversible nature. However all of the current diagnostic tests have serious limitations. Although elevated intraocular pressure (IOP) is a risk factor, most glaucoma patients actually have IOP within normal range. Visual field (VF) tests are poorly reproducible, and a series of 3 tests are needed to establish diagnosis or confirm progression. Although ophthalmoscopic examination can detect optic nerve head (ONH) and nerve fiber layer (NFL) defects, reliability in diagnosis and tracking is hampered by its subjective and semi-quantitative nature. Although quantitative imaging with optical coherence tomography (OCT), scanning laser polarimetry (SLP), and confocal scanning laser ophthalmoscopy (cSLO) can more objectively detect ONH and NFL defects, their diagnostic accuracies are still not sufficient to be relied on alone for diagnostic screening. It has been estimated that about half of glaucoma patients in the US do not know that they have the disease. Thus, there is a need for improvements in glaucoma diagnostic technologies. One approach that deserves further exploration is blood flow imaging.
There is much circumstantial evidence that vascular factors play important roles in the pathophysiology of glaucoma:
- Systemic vasculopathy increases the risk of developing glaucoma. Hypertension, diabetes, and vasospastic conditions are all known risk factors. Normal tension glaucoma has also been linked to peripheral endothelial dysfunction and erectile dysfunction. This suggests that poor circulation may be a causative factor or a facilitative factor that predisposes the ONH to damage by elevated IOP.
- Decrease or fluctuation in ocular perfusion pressure was identified as an independent risk factor for progression in the Collaborative Normal-Tension Glaucoma Study and other studies. Nocturnal hypotension is also a risk factor for glaucoma progression.
- Medications that improve ocular perfusion appear to have protective effects that are not explained by the lowering of IOP.
- Optic disc hemorrhage and peripapillary atrophy are both associated with accelerated glaucoma progression. These finding may support a role for focal ischemia.
- Animal experiments show that increased IOP causes decreased ONH blood flow in the presence of low systemic blood pressure.
Despite the evidence, the management of glaucoma remains focused on the lowering of IOP, the one causative factor that responds to treatment and can be easily measured. Blood flow measurement is a research topic, but currently has no clinical role in the diagnosis, prognostic evaluation, or treatment of glaucoma. Therapies aimed at improving ocular circulation cannot be effectively developed without a practical method for quantitative and reproducible evaluation of ONH and retinal perfusion. Thus there is a great need to develop better technology for the evaluation of ocular circulation.
Using high-speed OCT systems, we have developed new methods to image and measure optic nerve head (ONH) and retinal blood flow. Preliminary results showed that VF loss was more highly correlated with retinal blood flow as measured by OCT than any neural structure measured by OCT or other imaging modality. Accordingly, the goal of the proposed project is to improve the diagnostic and prognostic evaluation of glaucoma by further developing novel functional OCT measurements using ultrahigh-speed (70-100 kHz) OCT technology.
Retinal blood flow, ONH circulation, optic disc rim volume, peripapillary nerve fiber layer volume, and macular ganglion cell complex volume are all pieces of the same glaucoma puzzle. This project will develop novel imaging methods that allow us to look at the whole picture using one tool - ultrahigh-speed OCT.
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Optical Coherence Tomography, Intraocular pressure, Optic nervehead, Nerve fiber layer
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma Group | Patients with clinically confirmed glaucomatous ONH or NFL defects, with or without VF abnormalities | |
| Normal Group | Volunteers with healthy eyes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of retinal non-perfusion areas in mm2
Measured: 5 years
Measure vessel density in percentage (%)
Measured: 5 years
Determine accuracy of sector visual field progression in OCT-based sector visual field simulation compared to actual visual field results. Measured in dB change over time.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study start25 Sep 2013
- Primary completion31 May 2031 (estimated)
- Study completion31 May 2031 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (estimated)
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
- Aiyin Chen, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957267
- Sponsor's protocol ID
- OHSU IRB #00009729
- Other IDs
- 1R01EY023285
- Acronym
- FSOCT
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2013
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Observational Study Using Functional and Structural Optical Coherence Tomography to Diagnose and Guide Treatment of Glaucoma
- ClinicalTrials.gov ID
- NCT01957267
- Acronym / sponsor ID
- FSOCT / OHSU IRB #00009729
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Optical Coherence Tomography, Intraocular pressure, Optic nervehead, Nerve fiber layer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 25 Sep 2013 (actual)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 8 Oct 2013 (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 specific aims of the clinical studies are to:
- Develop a directional high-resolution OCT and OCT angiography prototype to improve imaging of structure and perfusion.
- Validate wide-field OCT and OCT angiography parameters to improve early glaucoma detection.
- Simulate visual field results by combining structural and angiography OCT data.
- Assess abilities of above technologies and OCT-derived parameters on predicting glaucoma detection, conversion, and progression.
Detailed description
Glaucoma is the second leading cause of blindness in the US. The diagnosis and monitoring of glaucoma are important problems, not only because of its prevalence, but also because of its silent and irreversible nature. However all of the current diagnostic tests have serious limitations. Although elevated intraocular pressure (IOP) is a risk factor, most glaucoma patients actually have IOP within normal range. Visual field (VF) tests are poorly reproducible, and a series of 3 tests are needed to establish diagnosis or confirm progression. Although ophthalmoscopic examination can detect optic nerve head (ONH) and nerve fiber layer (NFL) defects, reliability in diagnosis and tracking is hampered by its subjective and semi-quantitative nature. Although quantitative imaging with optical coherence tomography (OCT), scanning laser polarimetry (SLP), and confocal scanning laser ophthalmoscopy (cSLO) can more objectively detect ONH and NFL defects, their diagnostic accuracies are still not sufficient to be relied on alone for diagnostic screening. It has been estimated that about half of glaucoma patients in the US do not know that they have the disease. Thus, there is a need for improvements in glaucoma diagnostic technologies. One approach that deserves further exploration is blood flow imaging.
There is much circumstantial evidence that vascular factors play important roles in the pathophysiology of glaucoma:
- Systemic vasculopathy increases the risk of developing glaucoma. Hypertension, diabetes, and vasospastic conditions are all known risk factors. Normal tension glaucoma has also been linked to peripheral endothelial dysfunction and erectile dysfunction. This suggests that poor circulation may be a causative factor or a facilitative factor that predisposes the ONH to damage by elevated IOP.
- Decrease or fluctuation in ocular perfusion pressure was identified as an independent risk factor for progression in the Collaborative Normal-Tension Glaucoma Study and other studies. Nocturnal hypotension is also a risk factor for glaucoma progression.
- Medications that improve ocular perfusion appear to have protective effects that are not explained by the lowering of IOP.
- Optic disc hemorrhage and peripapillary atrophy are both associated with accelerated glaucoma progression. These finding may support a role for focal ischemia.
- Animal experiments show that increased IOP causes decreased ONH blood flow in the presence of low systemic blood pressure.
Despite the evidence, the management of glaucoma remains focused on the lowering of IOP, the one causative factor that responds to treatment and can be easily measured. Blood flow measurement is a research topic, but currently has no clinical role in the diagnosis, prognostic evaluation, or treatment of glaucoma. Therapies aimed at improving ocular circulation cannot be effectively developed without a practical method for quantitative and reproducible evaluation of ONH and retinal perfusion. Thus there is a great need to develop better technology for the evaluation of ocular circulation.
Using high-speed OCT systems, we have developed new methods to image and measure optic nerve head (ONH) and retinal blood flow. Preliminary results showed that VF loss was more highly correlated with retinal blood flow as measured by OCT than any neural structure measured by OCT or other imaging modality. Accordingly, the goal of the proposed project is to improve the diagnostic and prognostic evaluation of glaucoma by further developing novel functional OCT measurements using ultrahigh-speed (70-100 kHz) OCT technology.
Retinal blood flow, ONH circulation, optic disc rim volume, peripapillary nerve fiber layer volume, and macular ganglion cell complex volume are all pieces of the same glaucoma puzzle. This project will develop novel imaging methods that allow us to look at the whole picture using one tool - ultrahigh-speed OCT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma Group | – | –Patients with clinically confirmed glaucomatous ONH or NFL defects, with or without VF abnormalities |
| Normal Group | – | –Volunteers with healthy eyes |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll both males and females and include all ethnic and racial groups through clinical practices in the centers. The study will enroll subjects in the older adult age range commonly affected by glaucoma - 40 years or older. The study will exclude people with life-threatening or debilitating illness that would make 5-year participation unlikely or cooperation with tests difficult. For similar reasons those older than 85 years are excluded. The study also excludes those with any disease that might confound the diagnosis of glaucoma. Otherwise people with any health status are eligible for enrollment. Two groups of participants are recruited in the study: healthy controls or participants with confirmed glaucoma.
Key inclusion criteria (6 listed)
- ONH or NFL defect visible on slit-lamp biomicroscopy defined as one of following:
- Presence or absence of VF defects as measured by Humphrey SITA 24-2 VF.
Key exclusion criteria (10 listed)
- Best-corrected visual acuity less than 20/40
- Age < 40 or >85 years
- Refractive error of > +3.00 D or < -7.00 D
- Previous intraocular surgery except for uncomplicated keratorefractive surgery and cataract extraction with posterior chamber intraocular lens implantation
- Diabetic retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure of retinal non-perfusion areas in mm2
Time frame: 5 years
Measure vessel density in percentage (%)
Time frame: 5 years
Determine accuracy of sector visual field progression in OCT-based sector visual field simulation compared to actual visual field results. Measured in dB change over time.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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.
Aiyin Chen, 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, 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chinmay Deshpande, M.Optom. (503-494-9628, deshpanc@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of retinal non-perfusion areas in mm2 (time frame: 5 years). The study lists 3 primary outcomes in all. 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 9 Sep 2026.