Amblyogo" a 'smart' easy-to-use occlusion dose monitor (ODM) for amblyopia in children

The National Eye Institute awarded Edge Eye Labs Inc. $1,123,233 on August 10, 2026, to develop and validate AMBLYOGO, a patent-protected occlusion dose monitoring system for objectively tracking patch wear in amblyopia treatment. The award is a Project Grant under the Vision Research program (CFDA 93.867).

Amblyopia affects 2–4% of the U.S. pediatric population and is the most common cause of visual impairment in children. Occlusion patching is the standard therapy, but adherence is poor; objective data show children wear patches only approximately 44% of prescribed time, prolonging treatment and reducing visual outcomes. No FDA-cleared device currently exists to monitor patch wear objectively in clinical practice.

AMBLYOGO integrates dual magnetometers in a clip-on sensor worn on a child's glasses to detect a magnet embedded in the occlusion patch. Data transmit via Bluetooth to a base station and cloud platform, enabling real-time monitoring and feedback to parents and clinicians. Prior Phase I-equivalent pilot studies demonstrated high acceptability among children and families, strong concordance between device-recorded and parent-reported wear, and comfortable wear without reducing willingness to patch.

This direct-to-Phase II project will finalize and validate a commercial-ready system through three objectives: regulatory preparation including design history file initiation, ISO 14971-compliant risk assessment, and FDA pre-submission engagement on the De Novo pathway, usability testing, and cybersecurity requirements; engineering development and design verification of the glasses-mounted sensor, wireless base station, and secure cloud analytics platform; and bench testing to verify sensor accuracy and battery performance.

Performance occurs in San Francisco, California. The period of performance extends from August 10, 2026, through May 31, 2028.

Abstract

Amblyopia, the most common cause of visual impairment in children, affects 2-4% of the pediatric population in the united states. While occlusion patching is the gold-standard therapy, adherence is notoriously poor: parental reports overestimate use, and objective studies confirm that children wear their patches only ~44% of the prescribed time. This results in prolonged treatment, suboptimal visual outcomes, and unnecessary lifetime economic burden. Despite decades of clinical consensus on the effectiveness of patching, no FDA-cleared solution currently exists to objectively monitor patch wear in routine practice. Edge eye labs has developed amblyogo, a novel, patent-protected occlusion dose monitoring (ODM) system that integrates dual magnetometers in a clip-on sensor worn on a child's glasses to detect a small magnet embedded in the occlusion patch. Data are transmitted via bluetooth to a base station and cloud platform, enabling real-time monitoring and feedback for parents and clinicians. In phase i-equivalent pilot studies, amblyogo demonstrated high acceptability among children and families and strong concordance between ODM-recorded wear and parental diaries. Early clinical feedback confirms that the device can be worn comfortably without reducing willingness to patch. This direct-to-phase II project will finalize and validate a commercial-ready system through three specific aims: 1. Regulatory preparation - initiate the design history file, conduct ISO 14971-compliant risk assessment, and engage FDA via a pre-submission meeting to clarify the DE novo pathway, usability testing requirements, and cybersecurity expectations. 2. Engineering development and design verification - develop and optimize the glasses-mounted sensor, wireless base station, and secure cloud analytics platform. Bench testing will verify sensor accuracy, battery performance, wireless reliability, and child-safe ergonomics. 3. Device validation: interference, usability, and human evaluation - conduct human factors studies, pediatric usability testing, and pilot home use with ~20 children to validate accuracy, sensitivity, and integration into caregiver/clinician workflows. Expected outcomes include a refined amblyogo system built under FDA design controls, validated in real- world use, and positioned for regulatory clearance and commercialization. By enabling objective measurement of occlusion therapy, amblyogo has the potential to improve adherence by at least 20 percentage points, significantly enhance visual outcomes, and generate measurable healthcare cost savings. Beyond individual patient impact, amblyogo will provide a research platform to define true dose-response relationships in amblyopia, advancing precision pediatric ophthalmology worldwide.