CLAD Deconvolved PERG Responses in Glaucoma Patients

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:

• Age 18 to 85 years, inclusive

• Refractive errors within -5 to +3 diopters

• Best corrected visual acuity (BCVA) better than or equal to 20/30 (Snellen)

• Normal standard automated perimetry (SAP) according to the Ocular Hypertension Treatment Study (OHTS) criteria15 (reliability \< 15% on all indices, normality \> 5% on all global indices in two consecutive sessions 6 months apart)

• Minimum untreated Intraocular pressure IOP of 15 mm Hg

• Glaucoma Suspect Status defined as one or more of the following:

‣ Glaucomatous optic disc appearance (vertical cup-to-disc ratio \[C/D\] ≥0.5

⁃ Cup disc ratio asymmetry ≥0.2

⁃ Localized thinning of the disc

⁃ Presence or history of splinter disc hemorrhage

⁃ Moderately increased IOP (\>21 to \<28 mm Hg).

⁃ Family history of vision loss for glaucoma

Locations
United States
Florida
University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street
RECRUITING
Miami
Contact Information
Primary
Jonathon A Toft-Nielsen, PhD
jtoftnielsen@jorvec.com
305-668-6102
Backup
Edward Miskiel, PhD
emiskiel@jorvec.com
305-688-6102
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 120
Treatments
Experimental: Glaucoma Suspects
Patients with suspicion of glaucoma based on positive factors of disease.
Active_comparator: Controls
Age matched controls to the glaucoma suspect group with no indications of glaucoma.
Sponsors
Collaborators: University of Miami
Leads: Jorvec Corp.

This content was sourced from clinicaltrials.gov