CLAD Deconvolved PERG Responses in Glaucoma Patients

Description

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

Glaucoma, Suspect

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Study Overview

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Study Details

Study overview

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.

CLAD Deconvolved PERG Responses in Glaucoma Patients

CLAD Deconvolved PERG Responses in Glaucoma Patients

Condition
Glaucoma, Suspect
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Jorvec Corp.,

Study Record Dates

2025-06-01