# Neuro-Optical Diagnostic System for Macular Degeneration

> **NIH NIH R44** · NEUROFIELDZ, INC. · 2021 · $964,339

## Abstract

Age-related macular degeneration (AMD) causes progressive loss of central vision and is the leading
cause of blindness in the developed world. People with AMD manifest delayed dark adaptation (DA) recovery.
DA tests are a FDA approved method for diagnosing AMD in which a flash illumination bleaches rod and cone
photoreceptors and the subsequent recovery is a measure of the stress response of retinal metabolism. There
is an unmet need for a rapid, practical, sensitive and objective test that will provide quantitative endpoints for
early diagnosis and monitoring response to newly developed treatments. Visual evoked potentials (VEP)
generated in response to visual stimuli, provide a quantitative objective measure of the neuro-optical pathways
and visual processes that do not require sustained attention from the patient. NeuroFieldz has developed a new
system called NeuroDotVR that combines a high-resolution sensor for scalp electric potentials and fields with a
smartphone powered headmount display and measures VEP objectively during DA recovery.
 In the Phase I STTR project 1R41AG057250-01, we developed custom stimuli for macular DA and
validated the VEP measurements in normal controls and patients with confirmed diagnosis of AMD, ranging in
age from 18 to 88. DA was measured simultaneously in 4 retinal locations (2 per eye) in an easy-to-
administer test lasting around 15 minutes in total. The results of the Phase I proposal establish that
DAVEP can be successfully implemented in a busy clinic on naïve patients with various levels of visual
impairment and the test is well tolerated. All Phase I performance milestones were met. In this Phase II
SBIR proposal we will further develop and validate the DA-VEPF system toward eventual 510(k) FDA approval.
The project aims are: Specific Aim 1: Develop additional tests of DA-VEPF Multi-focal stimuli will be further
developed and the DA-VEPF results will be correlated with other visual biomarkers. Aim 1.1 Study Compliance
Monitoring. Aim 1.2 Cross threshold stimulus intensity sweeps with adaptive challenge branch. Specific Aim 2:
Validate in human studies The DAVEP system will be validated in a larger cohort of 100 subjects to establish
definite diagnostic criteria for early and late stage AMD. Aim 2.1 Compliant Multi-Focal Adaptive DAVEP as a
function of AMD stage. Aim 2.2 Test-Retest Reliability of DAVEP as a function of AMD stage. Aim 2.3
Comparison of DAVEP and Behavioral estimates of Dark Adaptation Recovery. Aim 2.4– Advanced Signal
Processing and Analytical Algorithm Development. Specific Aim 3: Enabling studies for 510(K) application
In preparation for an FDA 510(k) clearance to market application, we will research: 1) Market Strategy: Customer
Discovery; Reimbursement Overview; Partner Identification. 2) Regulatory Assessment for 510(k) application.
3) Scale-up manufacturing strategy.

## Key facts

- **NIH application ID:** 10237408
- **Project number:** 5R44AG057250-03
- **Recipient organization:** NEUROFIELDZ, INC.
- **Principal Investigator:** Craig Versek
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $964,339
- **Award type:** 5
- **Project period:** 2017-09-15 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10237408

## Citation

> US National Institutes of Health, RePORTER application 10237408, Neuro-Optical Diagnostic System for Macular Degeneration (5R44AG057250-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10237408. Licensed CC0.

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