Research Project
9135029
? DESCRIPTION (provided by applicant): Intraocular pressure (IOP) is arguably the second most important criteria used to assess visual acuity when eye care professionals are diagnosing, treating, and managing patients. The patented Intuor Applanation Tonometer (IAT) prism design is a novel and simple approach for improving the accuracy of IOP measurement in the eye. The proposal describes an inexpensive and easily adoptable approach to improving the accuracy of what has been considered the `gold standard' of IOP measurement for many decades: the Goldmann Applanation Tonometry (GAT). Experts in the field identified significant errors in patient variability in the GAT IOP measurements for corneal thickness, rigidity, curvature, and tear film. The combined error of patient variable parameters is potentially sight threatening to a large population of patients including those with glaucoma or undiagnosed ocular hypertension from other causes. However, currently this is still the best clinical method available. Attempts to develop other IOP correcting tonometers had limited success due to being cumbersome to use and expensive. In contrast, our approach, Intuor Applanation Tonometry (IAT), optimizes the shape of the GAT's prism surface, without any change in measurement technique or examination time, and addresses all known errors in GAT IOP measurements, and accomplishes this with minimal expense (less than $400). Preliminary mathematical modeling of the IAT indicates at least 50% reduction in each error parameter when compared to the GAT, significantly improving the fidelity of IOP measurement. Intuor's novel technology will support the NIH/NEI mission by improving human health and function through maximizing the care provider's ability to more accurately measure the patient's IOP, guiding both individual patient diagnosis and treatment as well as improved global evaluation of disease processes and treatment modalities. The IAT will also reduce healthcare costs through more timely diagnosis and accurate treatment. Intuor Technologies would utilize a Phase I award to accomplish three specific aims: 1. utilize an existing opto-mechanical mathematical model to optimize the design of our IAT, 2. build and verify a working ex-vivo optimized prototype to demonstrate substantial equivalence of the IAT prism to the GAT prism for medical device FDA 510(k) submission, and 3. demonstrate the optimized IAT prototype in-vivo comparing it to the GAT using a true intracameral IOP. Most importantly, after achieving these aims Intuor Technologies will be able to proceed directly to commercialization and marketing.
