Recruiting
Functional and Structural Imaging for 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.
ClinicalTrials.gov IDNCT01957267
PhaseNot Applicable
Enrollment249
SponsorOregon Health and Science University
Age40 Years
SexALL
Conditions studied
Glaucoma
About this study
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 outcomes
- Measure of retinal non-perfusion areas in mm2 (5 years)
- Measure vessel density in percentage (%) (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. (5 years)
Eligibility information
Inclusion Criteria: Normal Subjects (both eyes must meet all criteria)
1. No history or evidence of retinal pathology or glaucoma
2. 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%).
3. Intraocular pressure \< 21 mm Hg
4. Central corneal pachymetry \> 500 microns
5. No chronic ocular or systemic corticosteroid use
6. Open angle (gonioscopy must show 75% or more of the angle to be Grade 2 or more by Shaffer's grading system)
7. 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
8. Symmetric ONH between left and right eyes: CDR difference \< 0.2 in both vertical and horizontal dimensions
Inclusion criteria: Glaucoma Group
1. ONH or NFL defect visible on slit-lamp biomicroscopy defined as one of following:
1. diffuse or localized thinning of the rim
2. disc (splinter) hemorrhage
3. notch in the rim
4. vertical cup/disc ratio greater than the fellow eye by \> 0.2
2. Presence or absence of VF defects as measured by Humphrey SITA 24-2 VF.
Exclusion Criteria: All Groups
1. Best-corrected visual acuity less than 20/40
2. Age \< 40 or \>85 years
3. Refractive error of \> +3.00 D or \< -7.00 D
4. Previous intraocular surgery except for uncomplicated keratorefractive surgery and cataract extraction with posterior chamber intraocular lens implantation
5. Diabetic retinopathy
6. Other diseases that may cause VF loss or optic disc abnormalities
7. Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil
8. Inability to perform reliably on automated VF testing
9. Life-threatening or debilitating illness making it unlikely patient could successfully complete the study.
10. Refusal of informed consent or of commitment to the full length of the study
Study locations
- Oregon Health & Science University, Casey Eye Institute, Portland, Oregon 97214 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-02.