Glaucoma
Conditions
Keywords
Pattern Electroretinogram (PERG), Flash Electroretinogram (FERG)
Brief summary
The main goal of the study is to compile a normative database for the Neuro Optic Vision Assessment (NOVATM) Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules. This normalization intends to be included in a probabilistic analysis protocol to allow NOVATM PERG/FERG users to identify patients with results outside the normal ranges.
Detailed description
Investigators plan to enroll 50 subjects at Wills Eye Hospital without any eye diseases. Participants will undergo a complete eye examination to determine eligibility, including visual acuity testing, intraocular pressure (IOP) in millimeters of mercury (mmHG), and visual field (VF) testing. Participants will then be tested with Diopsys NOVA™ PERG & FERG systems. For both tests, two electrodes are placed on the skin underneath each eye below the eyelashes. Participants' skin will be cleaned before electrodes are placed. A small amount of gel will be placed on skin where electrodes are placed for testing. Electrical responses are recorded with electrodes in response to visual stimuli.
Interventions
DIAGNOSTIC_TESTDiopsys NOVA
Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules.
Sponsors
Wills Eye
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers age 18 years * older with normal eye exam
Exclusion criteria
* spherical refraction outside + 5.0 Diopters and cylinder correction outside + 3.0 Diopters. * IOP (intraocular pressure) ≥ 22 mm Hg (millimeters of mercury) * history of any type of glaucoma in either eye. * Intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 1 year before enrollment). * Best corrected visual acuity worse than 20/40. * Evidence of diabetic retinopathy, diabetic macular edema, or other vitreo-retinal disease in either eye. * Evidence of optic nerve, macula and/or retinal nerve fiber layer abnormality in either eye. * Evidence of reproducible (false positives, fixation losses and false negatives ≤ 25% with no observable testing artifacts). * Standard Automatic Perimetry (SAP) abnormality in either eye, defined as Pattern Standard Deviation \< 5% level, and/or abnormal Glaucoma Hemifield test result, and/or any other pattern of loss which is consistent with a neurologic and/or ocular disease. * Current or recent (within the past 30 days) use of an agent (by any administering method) known to affect visual function. * Inability to obtain reliable PERG/FERG (Pattern Electroretinogram/Flash Electroretinogram) results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flash Electroretinogram (FERG) Module Using Diopsys NOVA (Neuro Optic Vision Assessment) Amplitude | 2 hours | Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) amplitude in micro volts. |
| Flash Electroretinogram (FERG) Module Using Diopsys NOVA Latency | 2 hours | Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) latency in milliseconds. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Controls 51 Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA.
Diopsys NOVA: Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Healthy Controls |
|---|---|
| Age, Continuous | 53.3 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 20 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
Flash Electroretinogram (FERG) Module Using Diopsys NOVA Latency
Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) latency in milliseconds.
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Controls | Flash Electroretinogram (FERG) Module Using Diopsys NOVA Latency | 107.39 milliseconds | Standard Deviation 10.22 |
Primary
Flash Electroretinogram (FERG) Module Using Diopsys NOVA (Neuro Optic Vision Assessment) Amplitude
Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) amplitude in micro volts.
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Controls | Flash Electroretinogram (FERG) Module Using Diopsys NOVA (Neuro Optic Vision Assessment) Amplitude | -1.68 micro volts | Standard Deviation 0.78 |