Actively Recruiting
CLAD Deconvolved PERG Responses in Glaucoma Patients
Led by Jorvec Corp. · Updated on 2024-05-16
120
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
J
Jorvec Corp.
Lead Sponsor
U
University of Miami
Collaborating Sponsor
AI-Summary
What this Trial Is About
Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease is critical so patients may obtain treatment to preserve useful vision. This study will collect data from a population of glaucoma suspects (with positive factors for the disease but with normal vision) along with a population of age matched controls using the pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) which come together to form the optic nerve. RGCs may become dysfunctional before dying. The Continuous loop deconvolution technique (CLAD) will be used to extract transient PERG responses in both glaucoma suspects and age matched controls. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests over 2 years. CLAD will be compared with conventional techniques of monitoring glaucoma (standard PERG, OCT, visual field etc) to see if the CLAD is better at distinguishing between glaucoma suspects and controls.
CONDITIONS
Official Title
CLAD Deconvolved PERG Responses in Glaucoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years, inclusive
- Refractive errors between -5 and +3 diopters
- Best corrected visual acuity of 20/30 or better
- Normal automated visual field tests according to OHTS criteria in two sessions six months apart
- Untreated intraocular pressure of at least 15 mm Hg
- Glaucoma suspect status defined by one or more of: optic disc appearance with cup-to-disc ratio ≥0.5, cup-disc ratio asymmetry ≥0.2, localized disc thinning, splinter disc hemorrhage history, moderately increased intraocular pressure (>21 to <28 mm Hg), or family history of glaucoma-related vision loss
You will not qualify if you...
- Age-related macular degeneration
- Diabetes
- Parkinson's disease
- Multiple sclerosis
- Unable or unwilling to consent, accept randomization, or attend scheduled visits
- Pregnant or nursing women
- Currently using prescribed pressure lowering medicines and unwilling to stop
- High OHTS risk score warranting treatment rather than randomization
- Optical coherence tomography abnormalities consistent with glaucoma
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
J
Jonathon A Toft-Nielsen, PhD
CONTACT
E
Edward Miskiel, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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