Regulatory Assistance for nGoggle Device for Ophthalmic Indications

PROJECT SUMMARY Glaucoma is a leading cause of irreversible blindness and disability The disease can remain relatively asymptomatic until the late stages therefore early detection and monitoring of vision damage is paramount to prevent functional impairment and blindness Detection of functional visual loss in the disease has traditionally been made using standard automated perimetry SAP However SAP testing is limited by the cost and complexity of its procedure the subjectivity of patient responses the large variability among subsequent tests and the lack of portability of the equipment The overall goal of this proposal is to address the limitation of currently available techniques by developing a portable objective method for the assessment of visual field loss in glaucoma The founders of NGoggle Inc have demonstrated that the use of multi focal steady state visual evoked potentials mfSSVEPs provides a simpler more consistent and objective way to assess visual system integrity Compared to the existing technologies mfSSVEP based perimetry will be simpler to perform faster in producing the results and perhaps more accurate in the diagnosis due to better signal to noise ratios SNRs of its acquired data In this Phase I SBIR project we will leverage the founder s discoveries and innovations to develop the NeuroGoggle a portable objective method for assessing human functional visual field loss The NeuroGoggle assesses patient s visual function based on his her mfSSVEP responses that is evoked by a constellation of multi frequency multi focal visual stimuli presented by a head mounted display and recorded using a wireless EEG acquisition system This project has the Specific Aim To develop a wearable objective high precision mfSSVEP based visual field assessment prototype system which will be comfortable to wear easy to operate and capable of acquiring high SNR EEG EOG signals robustly in real world environments Successful development of the NeuroGoggle will provide a much needed device that will enable patients to administer visual function tests quickly and easily at home by themselves or with the help of a companion This will hence reduce the required number of office visits and lighten the economic and emotional burden of the disease PROJECT NARRATIVE NGoggle Inc is developing a new device named the NeuroGoggle for early glaucoma detection and progression monitoring This wearable device uses a wireless electroencephalogram EEG acquisition system and a head mounted display to perform objective assessment of patient s functional visual field loss By analyzing a specific EEG response of the patient known as multi focal steady state visual evoked potentials mfSSVEP towards multi frequency flickering light patterns NeuroGoggle will enable objective evaluation of visual field deficits beyond clinical environments improve the efficiency in diagnosing glaucoma and monitoring its progression and thus reducing the chance of visual impairment or blindness caused by the disease