Evaluating retinal responses in glaucoma suspects

CLAD Deconvolved PERG Responses in Glaucoma Patients

This study is testing a new eye test to see if it can better track changes in the eyes of people who might have glaucoma compared to standard methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Jorvec Corp. (Industry-sponsored)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT06388096 on ClinicalTrials.gov

What this trial studies

This study aims to assess the function of retinal ganglion cells in individuals suspected of having glaucoma, using a technique called Continuous loop deconvolution (CLAD) applied to pattern electroretinogram (PERG) responses. Participants, aged 18 to 85, will undergo a series of eye tests, including PERG, Optical Coherence Tomography (OCT), and visual field assessments over a two-year period. The goal is to determine if CLAD provides better insights into glaucoma progression compared to conventional monitoring methods. The study will include both glaucoma suspects and age-matched controls to establish a comprehensive understanding of retinal function.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 who are classified as glaucoma suspects with specific risk factors but have normal vision.

Not a fit: Patients with conditions such as age-related macular degeneration, diabetes, or other significant ocular diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection and better management of glaucoma, potentially preserving vision for many patients.

How similar studies have performed: While the use of PERG and OCT in glaucoma monitoring is established, the specific application of CLAD in this context is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Miami, Florida

• University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street — Miami, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Jonathon A Toft-Nielsen, PhD

Conditions Glaucoma, Suspect; Glaucoma