Normative Database for Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG)
Completed · Not applicable
Conditions studied: Glaucoma
In brief
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.
Key facts
- Study ID
- NCT02609204
- Run by
- Wills Eye
- People needed
- 51
- Starts
- 2014-11-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2018-12-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy volunteers age 18 years
- older with normal eye exam
You may not qualify if…
- 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.
Where it is running
- Wills Eye Hospital — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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