SBIR-STTR Award

In treating glaucoma, the clinician attempts to lower the intraocular pressure (IOP) but, because it is not constant, a single measurement during a visit to the ophthalmologist may be unreliable. The measurement of the IOP at the patient's home has been advocated but has been hampered by the lack of an instrument that can be used reliably and safely by the patient alone. A self-tonometer, recently developed by academic researchers, has been successfully implemented in clinical research. The goal of this project is to make the self-tonometer available to the ophthalmic community by converting the prototype into a commercial product. Phase I will consist of introducing a microprocessor to control the operation, register and check the readings, provide feedback to the patient, and archive the IOP, time, and date until the data are processed at the clinician's office. A computer-controlled pressure generator will also be developed. The upgraded version will be tested and its function compared to that of the existing prototype. Phase II will be dedicated to specifying, designing, developing, and testing a commercial prototype.

Anticipated Results:
It is anticipated that, if the preliminary results available today are confirmed by independent clinicians, many ophthalmologists treating about two million Americans with glaucoma will introduce the upgraded self-tonometer to their diagnostic armamentarium.National Eye Institute (NEI)

In treating glaucoma, clinicians attempt to lower patient's intraocular pressure (IOP). The IOP is not constant however, and a single measurement taken during a visit to the ophthalmologist may be unreliable. The desirable measurement of the IOP at the patient's home has been hampered by the lack of an instrument. A self tonometer, recently developed and implemented in clinical research, has been cited among the progresses in the priority areas set in the NEI National Plan. The goal is to make the self tonometer available to the ophthalmic community by converting it into a commercial product. Phase II is designed to complete the implementation of a microcomputer; write programs to analyze the readings and provide immediate feedback to the patient; allow for battery operation; upgrade the sensor head into a manufacturable component; develop a disposable probe; write a program for office computers to download the data and present diurnal IOP curves. The self-tonometer will be evaluated in the clinics often independent glaucoma experts; its readings will be correlated with those of the Goldmann tonometer; and its application to monitoring the IOP of glaucoma patients at their home and work place will be assessed. Phase III will be dedicated to manufacturing the instrument and obtaining FDA approval for its commercial use.Awardee's statement of the potential commercial applications of the research:It is anticipated that, if the preliminary results available today will be confirmed by independent clinicians, many ophthalmologists treating about two million patients with glaucoma will introduce the upgraded self tonometer among their diagnostic armainentarium.National Eye Institute (NEI)