RECRUITINGINTERVENTIONAL

CLAD Deconvolved PERG Responses in Glaucoma Patients

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 Currently using prescribed pressure lowering medicines and unwilling to be withdrawn from them. 8.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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DIAGNOSTIC_TEST

Pattern Electroretinogram

Non-invasive recording of retinal potentials from a modulating pattern stimulus viewed on a visual display and recorded from surface electrodes around the eye.

Locations (1)

University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street

Miami, Florida, United States