N/A
N=51
Normative Database for Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG)
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT02609204 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Flash Electroretinogram (FERG) Module Using Diopsys NOVA (Neuro Optic Vision Assessment) Amplitude — -1.68 micro volts
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diopsys NOVA (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wills Eye
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Flash Electroretinogram (FERG) Module Using Diopsys NOVA (Neuro Optic Vision Assessment) Amplitude |
-1.68 | — |
| PRIMARY Flash Electroretinogram (FERG) Module Using Diopsys NOVA Latency |
107.39 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02609204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.