Glaucoma Clinical Trial
— FSOCTOfficial 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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | May 2026 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health & Science University, Casey Eye Institute | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University | National Eye Institute (NEI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure of retinal non-perfusion areas in mm2 | 5 years | ||
Primary | Measure vessel density in percentage (%) | 5 years | ||
Primary | 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 |
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