Comparing SD-tVEP and PERG Tests Between Patients With Glaucoma, Patients With High Eye Pressure and "Normal" Patients
NCT ID: NCT02604953
Last Updated: 2017-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2014-07-31
2015-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ocular Hypertension patients
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.
Short Duration Transient Visual Evoked Potential (SDtVEP)
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.
Pattern electroretinogram (PERG)
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.
Healthy Controls
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.
Short Duration Transient Visual Evoked Potential (SDtVEP)
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.
Pattern electroretinogram (PERG)
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.
Glaucoma patients
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.
Short Duration Transient Visual Evoked Potential (SDtVEP)
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.
Pattern electroretinogram (PERG)
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.
Interventions
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Short Duration Transient Visual Evoked Potential (SDtVEP)
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.
Pattern electroretinogram (PERG)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 21 - 80 years
* IOP more than 21 mm hg in both the eyes.
* Open angles on Gonioscopy
* At least 2 normal and reliable visual fields (Humphrey MD \>-2 or Octopus MD ≤0.8; fixation losses, false-positive rate, and false-negative rate each \< 33%)
* Normal optic disks, without any of the following signs: rim notches, peripapillary splinter hemorrhages, or C/D asymmetry \>0.2 between the two eyes
* BCVA ≥ 20/40, Clear media, Pupil diameter \> 3 mm and symmetric
* Spherical refraction within + 5.0 D and cylinder correction within + 3.0 D.
* Patients diagnosed with mild, moderate or severe open angle glaucoma as per the (365.xx)
* Age between 21 - 80 years.
* Patients who attend regular follow-up.
* Individuals with no ocular hypertension or any type of glaucoma.
* Available to participate in the study during the required time frame.
* Age 21-80 years.
Exclusion Criteria
* Neurological or musculoskeletal problems that would influence performance on activities of daily living.
* Laser therapy within the previous month.
* Any cause for visual reduction (greater than 20/40 VA) other than glaucoma.
* Any medical condition which in the investigator's opinion would preclude the subject from providing reliable and valid data.
* History of hypersensitivity to Bimatoprost and Brimonidine, or currently taking an MAO inhibitor
* Currently taking any IOP lowering therapies.
21 Years
80 Years
ALL
Yes
Sponsors
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Wills Eye
OTHER
Responsible Party
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Anand Mantravadi
Principal Investigator
Principal Investigators
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Anand Mantravadi, MD
Role: PRINCIPAL_INVESTIGATOR
Wills Eye Hospital
Other Identifiers
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13-358
Identifier Type: -
Identifier Source: org_study_id