An observational study in Glaucoma, sponsored by Wills Eye. Completed. Open to participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-02.
Sponsored by Wills Eye · Observational
Wills Eye Hospital Glaucoma Research Center will conduct a 1-year prospective study to assess the ability of a Short Duration Transient Visual Evoked Potential (SD- tVEP) and a Steady-State Pattern electro-retinogram (PERG) vision testing system to detect visual dysfunction in patients with ocular hypertension. The study aims to assess the reversibility of retinal ganglion cell (RGC) dysfunction after administering intraocular pressure (IOP) lowering treatment. The investigators hypothesize that SD-tVEP and PERG testing will help develop better treatment for glaucoma patients by increasing understanding of the physiological relationship of IOP and RGC in glaucomatous injury.
Glaucoma is the most common cause of irreversible blindness worldwide. It is characterized by the progressive loss of retinal ganglion cells (RGCs) and a corresponding loss of vision. Elevated intraocular pressure (IOP) is an important risk factor for glaucoma, but its role in the diagnosis of glaucoma is unclear. Although IOP-lowering therapy delays the onset of glaucoma in some patients with ocular hypertension, even without therapy, 90% of patients will not develop glaucoma over a 5-year period.
Visual evoked potentials (VEPs) are able to detect the disruption of electrical signals at any point along the visual pathway, from the RGCs to the primary visual cortex. As an objective measure of visual function, the VEP may have an advantage over traditional visual field tests, by reducing confounded factors such as age, fatigue, and mental status.
There is a growing body of evidence that SD-tVEP can objectively identify early visual dysfunction due to glaucoma.
Aim 1: Compare the results of the baseline SD-tVEP and PERG vision testing in patients with ocular hypertension to a cohort of 30 healthy subjects and a cohort of 30 patients with glaucoma (of varying severity) to determine its ability to detect visual dysfunction in ocular hypertensive subjects.
Aim 2: Conduct SD-tVEP and PERG testing system in 30 patients with ocular hypertension before and after IOP reduction with topical medication and compare the results of the SD-tVEP and PERG before and after treatment in each patient, to determine its ability to detect reversible RGC dysfunction.
1,844 studies on the registry are indexed under Glaucoma; 233 are open to participants now.
This study's enrollment of 90 is below the median of 103 across 454 observational studies indexed under Glaucoma.
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Ocular hypertension, glaucoma patients and healthy controls with no eye diseases.
Inclusion Criteria:
Inclusion Criteria for ocular hypertension patients (Group A):
Inclusion Criteria for glaucoma patients (Group B):
Inclusion Criteria for normal subjects (Group C):
Exclusion Criteria:
Ocular hypertension patients are recruited from the Wills Eye Hospital Glaucoma Service. Short Duration Transient Visual Evoked Potential (SD- tVEP) and Pattern electroretinogram (PERG) testing will be conducted.
Diagnostic Test: Short Duration Transient Visual Evoked Potential (SDtVEP) · Diagnostic Test: Pattern electroretinogram (PERG)
Healthy adults are recruited from staff, family and friends of Wills Eye Hospital Glaucoma Research Center. Short Duration Transient Visual Evoked Potential (SD- tVEP) and Pattern electroretinogram (PERG) testing will be conducted.
Diagnostic Test: Short Duration Transient Visual Evoked Potential (SDtVEP) · Diagnostic Test: Pattern electroretinogram (PERG)
Glaucoma patients are recruited from the Wills Eye Hospital Glaucoma Service. Short Duration Transient Visual Evoked Potential (SD- tVEP) and Pattern electroretinogram (PERG) testing will be conducted.
Diagnostic Test: Short Duration Transient Visual Evoked Potential (SDtVEP) · Diagnostic Test: Pattern electroretinogram (PERG)
Short duration transient visual evoked potentials (VEPs) detect disruption of electrical signals at any point along the visual pathway, from the retinal ganglion cells (RGCs) to the primary visual cortex. As an objective measure of visual function, VEP may have advantage over traditional visual field tests, by reducing confounded factors such as age, fatigue, and mental status.
Also known as: SDtVEP
Pattern electroretinogram (PERG), an objective test, is used for evaluating early damage to retinal ganglion cells (RGC). In PERG, retinal response is recorded while patterns are viewed in the visual field on a computer monitor.
Also known as: PERG
Short Duration Transient Visual Evoked Potential (SD- tVEP)
Short Duration Transient Visual Evoked Potential (VEP) to objectively measure the functional responses of the entire visual pathway from the anterior segment of the eye to the visual cortex.
Time frame: 1 day
No study locations are listed for this record.
Plan to share: No — Data has been presented at the American Glaucoma Society in March 2015 and manuscript will be submitted for publication in 2017.
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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