NCT01957267 · Oregon Health and Science University
Functional and Structural Imaging for Glaucoma
(FSOCT)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Normal Subjects (both eyes must meet all criteria)
- No history or evidence of retinal pathology or glaucoma
- Normal Humphrey 24-2 VF: A mean defect (MD), corrected pattern standard deviation (CPSD) within 95% limits of normal reference, and glaucoma hemifield test (GHT) within normal limits (97%).
- Intraocular pressure \< 21 mm Hg
- Central corneal pachymetry \> 500 microns
- No chronic ocular or systemic corticosteroid use
- Open angle (gonioscopy must show 75% or more of the angle to be Grade 2 or more by Shaffer's grading system)
- Normal appearing ONH and NFL: vertical and horizontal cup/disc ratio (CDR) ≤ 0.5 and intact neuroretinal rim without peripapillary hemorrhages, notches, localized pallor, or NFL defect
- Symmetric ONH between left and right eyes: CDR difference \< 0.2 in both vertical and horizontal dimensions Inclusion criteria: Glaucoma Group
- 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.
Exclusion criteria
- 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
- 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
Where
- Portland, Oregon
Collaborators
National Eye Institute (NEI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 4, 2026 · Source of record for eligibility and locations