AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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.

Chinmay Deshpande, M.Optom. contact

503-494-9628

deshpanc@ohsu.edu

Denzil Romfh, OD contact

503-494-4351

romfhd@ohsu.edu

United States1 site, 1 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

    Recruiting

Other trials in United States

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:

  1. 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.
  2. 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.
  3. Medications that improve ocular perfusion appear to have protective effects that are not explained by the lowering of IOP.
  4. Optic disc hemorrhage and peripapillary atrophy are both associated with accelerated glaucoma progression. These finding may support a role for focal ischemia.
  5. 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 groups in NCT01957267
Study groupRoleWhat they receive
Glaucoma GroupPatients with clinically confirmed glaucomatous ONH or NFL defects, with or without VF abnormalities
Normal GroupVolunteers with healthy eyes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure of retinal non-perfusion areas in mm2

    Measured: 5 years

  2. Measure vessel density in percentage (%)

    Measured: 5 years

  3. 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.

  1. First posted8 Oct 2013 (estimated)
  2. Study start25 Sep 2013
  3. Primary completion31 May 2031 (estimated)
  4. Study completion31 May 2031 (estimated)

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in