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CLAD Deconvolved PERG Responses in Glaucoma Patients

NCT06388096 · Jorvec Corp.
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
The PERG is recorded from small metallic cups taped on the skin or contact electrodes on the face similarly to an electrocardiogram except that the location is the skin around the eyes. The only physical contact the subject will experience is a gentle cleaning of the skin with an alcohol prep pad. During the test the subject will be asked to look at a visual stimulus display for about 3 minutes. Depending on the experimental protocol, the subject may be asked to either sit during the test or to lie down in a bed. Lying down will cause a momentary increase of your eye pressure similar to the one that occurs during your normal sleep. This may help to understand whether or not your optic nerve functions normally when the pressure in your eye increases. For OCT evaluation, the pupil will be dilated with drops similar to those used in a standard eye exam. The subject will have to briefly look at a mark inside the instrument one eye at a time. For Visual field (VF) evaluation, the subject will be asked to look at a fixation mark inside the Visual Field testing equipment and asked to signal when they see small lights in their periphery. PERG, OCT and VF will be performed during the same day of the visit. If the participant has already done these tests in the past, as part of another study or as part of standard treatment, the results of these tests will be obtained from shier record, and be included in this study. RISKS: For the PERG, the only significant risk to you is a small chance of skin discomfort from the cleansing agent for skin electrodes, which should go away without treatment. For OCT, there is a rare risk to you of an allergic reaction to the drops used to dilate your pupils. The risk is even lower if you did not have any reaction during your previous eye exams. In case of an allergic reaction, your eye doctor will immediately treat it. If you had previous problems with pupil dilation, you may wish to speak to your eye doctor about the option of doing this additional test. There are no significant risks associated with VF testing
Eligibility criteria
Inclusion Criteria: 1. Age 18 to 85 years, inclusive 2. Refractive errors within -5 to +3 diopters 3. Best corrected visual acuity (BCVA) better than or equal to 20/30 (Snellen) 4. 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) 5. Minimum untreated Intraocular pressure IOP of 15 mm Hg 6. 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 Exclusion Criteria: 1. Age-related macular degeneration 2. Diabetes 3. Parkinson's disease 4. Multiple sclerosis 5. Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits. 6. Pregnant or nursing women. 7. Currently using prescribed pressure lowering medicines and unwilling to be withdrawn from them. 8. An OHTS risk score high enough in the judgment of the ophthalmologist or optometrist managing the patient to recommend pressure lowering medicine to the patient and not randomization. 9. An OCT abnormal enough in a pattern consistent with glaucoma.
Study design
Enrollment target: 120 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-06-01
Estimated completion: 2025-06-01
Last updated: 2024-05-16
Interventions
Diagnostic Test: Pattern Electroretinogram
Primary outcomes
  • PERG Amplitude (Immediately after measurement)
  • PERG Latency (Immediately after measurement)
Sponsor
Jorvec Corp. · industry
With: University of Miami
Contacts & investigators
ContactJonathon A Toft-Nielsen, PhD · contact · jtoftnielsen@jorvec.com · 305-668-6102
ContactEdward Miskiel, PhD · contact · emiskiel@jorvec.com · 305-688-6102
All locations (1)
University of Miami, Bascom Palmer Eye Institute 900 NW 17th StreetRecruiting
Miami, Florida, United States
CLAD Deconvolved PERG Responses in Glaucoma Patients · TrialPath