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Amblyopia Early Detection Device

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Amblyopia Early Detection Device

  1. 1. Q3D: Quantitative Three Dot Device Inventors: Carl Bassi, Michael Howe, and Wayne Garver -UMSL May 30, 2019
  2. 2. What is the problem? • Despite our knowledge about amblyopia it remains the most common cause of permanent vision impairment in children with estimates of 2% – 3% of children in the US. • If detected early enough amblyopia can be treated. However, it can sometimes be difficult to recognize early because the suppressed eye can appear normal. • Clearly a more sensitive testing device for the detection of visual suppression is needed. Presenters: Carl Bassi, PhD, and Tamara Wilgers
  3. 3. How does product/service solve problem? • The Q3D provides a quantitative measure of visual suppression by utilizing: – LEDs capable of >3 log unit change intensity – Pulse width modulated control of intensity • Fast (<1 minute) to administer and simple to operate and interpret • Clinical trials has shown it to be superior to the current “gold standard” (the Worth 4 dot test) Presenters: Carl Bassi, PhD, and Tamara Wilgers
  4. 4. What is the market use? The Q3D is a tool for amblyopia assessments by: • optometrists • ophthalmologists • technicians Because the Q3D is quantitative and more sensitive than current tests, it can: • detect suppression earlier • be used as a quantitative outcome measure for treatments Other potential applications include assessment and monitoring optic neuritis and TBI. Presenters: Carl Bassi, PhD, and Tamara Wilgers
  5. 5. What competition exists? Worth 4 Dot The screening technology currently on the market (Worth 4 Dot test) is a “blunt” instrument that can only measure suppression qualitatively and only when significant suppression is already present, most often when it is too late to prevent or reverse the condition. Presenters: Carl Bassi, PhD, and Tamara Wilgers
  6. 6. What is the status of the intellectual property? US Patent #7,686,452 entitled “Apparatus and Method for Assessing Visual Suppression” Canadian Patent #2676122 Claims cover the device, kits including the device and filters, and methods for determining depth of visual suppression in a subject. Presenters: Carl Bassi, PhD, and Tamara Wilgers
  7. 7. What is the stage of development? 3rd-Generation Prototype: The inventors were awarded a $50,000 University of Missouri System “FastTrack” award for the Q3D project to fund improved form factor of the Q3D device and optimization of the Q3D design to improve reliability and reduce manufacturing cost per device. Ten working prototypes with hardware, software, CAD design and circuit design documentation were produced. Clinical Trials Completed The Q3D has already been used in an initial pilot study with 30 patients (at UMSL) and then in a larger trial at St Louis University(>350 patients) Cardinal Glennon Clinic with Oscar Cruz, M.D. and Bradley Davitt, M.D.. The results indicated that the Q3D was 4X as likely to find visual suppression as the Worth 4 Dot test. Presenters: Carl Bassi, PhD, and Tamara Wilgers
  8. 8. What is needed for further development? The Q3D is nearly ready to come to market with patent protection, near production ready prototypes, and clinical trial evaluation. A commercial partner is needed for: • final design issues for production • FDA evaluation (initial evaluation has determined that the device will likely be FDA Class I exempt) • manufacturing • marketing/sales Presenters: Carl Bassi, PhD, and Tamara Wilgers

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