To demonstrate the feasibility of a home tonometer to monitor IOP without contact

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43MD006147-01A1
Agency Tracking Number: MD006147
Amount: $145,325.00
Phase: Phase I
Program: SBIR
Awards Year: 2010
Solitcitation Year: 2010
Solitcitation Topic Code: NIMHD
Solitcitation Number: PHS2010-2
Small Business Information
2182 Dupont Dr., UNIT 19, IRVINE, CA, 92612
Duns: 052663080
Hubzone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (949) 854-3972
Business Contact
Phone: (949) 885-8875
Research Institution
DESCRIPTION (provided by applicant): This research is to study the feasibility of an in-home tonometer based on the two color strobe technology (TCST) developed by CeeMaxTM Ophthalmic, a division of Achevi Technology. We are the manufacturer of ophthalmic diagnostic instruments with core expertise of solid state lighting and digital image systems. Our in-home non-contact tonometer does not require special skills to use. Once it approves feasible, it will allow thousands of patients with progressive glaucomatous damage to keep track of their intraocular pressure (IOP) between office visits and to provide their physicians with a complete picture of their individual IOP level and fluctuations. This device will expand our understanding of the glaucoma progression, improve glaucoma management, promote early diagnosis and enhance glaucoma medication or surgical treatment. The system will provide the relevant cornea anatomical parameters and one of the aims of this research is to create an algorithm enable the derivation of an IOP independent of the biomechanical properties of cornea. To validate our design we will compare the results of TCST with the results of a Goldmann applanation tonometer with an artificial eye model that includes various cornea configurations. Accuracy and repeatability of both measurements will be compared using a calibrated manometer as reference. We will conclude our innovation is feasible if TCST measurement demonstrates an accuracy of 11mm Hg and its repeatability is comparable with the repeatability of Goldmann tonometer measurements. Our patent pending concept requires a digital image system similar to a modern day cell phone with multi-color solid state strobes. Thus the device can be manufactured economically. The information from this device is very traceable and manageable because the size of the digital image file is relatively small. The IOP information can be derived locally or can be recorded and analyzed remotely via internet. In addition to the contribution to glaucoma management, this research will add another dimension to the 3-D anterior chamber topography. It will add the modulus and/or other relevant mechanical properties of cornea to the anatomical parameters of the cornea. Thus, this research could evolve into a new dynamic topographer that will expand our understanding of the cornea and further refine the refractive surgeries. Due to its independence of the cornea shape, this device will also address the unmet care for patients with keratoconus, the most common corneal dystrophy in the United States. . PUBLIC HEALTH RELEVANCE: This research will generate an important tool for the management of glaucoma, especially for early detection of glaucoma and for customized medication and/or surgical procedures, through two-color-strobe- technology (TCST) to achieve easy-to-use home monitoring of intraocular pressures (IOP) without contacting the cornea. This will allow quick detection and accurate IOP-based glaucoma events for use of event-adjusted therapeutics that will avoid the current adverse time delays that are associated with sporadic clinical visits in care of glaucoma patients.

* information listed above is at the time of submission.

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