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Since intraocular eye pressure (IOP) is the second most critical metric next to visual acuity for assessing the ocular health of a patient, our CATS Tonometer Prism™ has the potential to greatly enhance clinical care through a reduction in errors related to IOP measurements. The reusable version of the CATS Tonometer Prism™ has been cleared by the FDA for sale in the United States. Measurement of IOP is not only critical to the accurate diagnosis of ocular disease, but is also a necessary guide to effective treatment strategies. Measurement of IOP is not only critical to the accurate diagnosis of ocular disease, but is also a necessary guide to effective treatment strategies. The CATS Tonometer Prism™ is designed to enhance IOP measurements through an easily adopted modification to the surface of the GAT prism. Additionally, the CATS Tonometer Prism™ is designed to be easily implemented by the worldwide eye care community without altering existing practitioner protocols and with minimal costs related to only changing the GAT's tip.
Five scientific studies demonstrated the clinical performance of the CATS™ prism in comparison to the GAT prism. The peer-reviewed publications included a direct comparison to the existing GAT prism; human cadaver eye intracameral pressure transducer comparison of the CATS and GAT; an actual intracamerally placed pressure transducer comparison of the CATS and GAT in live human eyes, and tear-film hydrostatic study. All five studies confirmed our original mathematical modeling design predictions developed in a National Institute of Health, SBIR Phase I grant. Additionally, subgroups of pediatric patients and post-refractive (LASIK, PRK, SMILE, and RK) surgery patients - which combined represent 30% of the U.S. population - exhibit clinically relevant GAT errors in more than 50% of patients. Further testing in these populations with the CATS Tonometer is required to examine the prismís full potential. Our presentation on this topic won "Best Paper of Session" at the 2015 American Society of Cataract and Refractive Surgery (ASCRS) Conference. Additionally, presentations were also made at the 2017 ASCRS Annual Meeting, Los Angeles, May 7th, and the Association for Research in Vision and Ophthalmology (ARVO) Annual Conference, Baltimore, May 8th. We are scheduled to deliver presentations in 2018 at the American Glaucoma Society Annual Meeting in New York in March, the ASCRS Annual Meeting in Washington DC April 2018, and the ARVO Annual Conference in Hawaii in April 2018.
The CATS Tonometer Prism™ is FDA cleared for marketing and sale in the United States and we are in the process of securing the CE Mark.