Glaucoma is an optic nerve disease in which there is progressive loss of retinal ganglion cells leading to irreversible loss of vision. It is estimated to affect 2% of the general population. More than 2.3 million Americans are affected with glaucoma and it is estimated to account for nearly $3B in direct medical costs. It is estimated that 4% of Caucasian patients and 8% of African-American patients will experience blindness due to glaucoma. It is the second leading cause of blindness worldwide. High intraocular pressure (IOP) is the single largest, as well as the only modifiable, risk factor associated with glaucoma. Measuring and reducing IOP to levels that reduce the progression of visual field loss and nerve degradation is the current management approach for glaucoma. Typical treatment consists of IOP measurement in a clinical setting with a drug therapy of self-administered eye drops such as timolol and latanoprost. During periodic follow-ups, IOP and eye health is assessed and medication is adjusted as necessary until further progression is stopped or reduced. Reproducible and accurate IOP measurements are a critically important element of disease management. Goldman Applanation Tonometry (GAT) is the standard for measuring IOP. The significant limitations of GAT are that it provides an indirect IOP measurement and measures IOP at a single moment in time. However, even with these limitations, GAT has remained the gold standard for measuring IOP in the management of glaucoma. To overcome this, we propose the use of a micro-miniature, telemetric pressure sensor device for measuring IOP continuously and directly. The successful Phase I feasibility study provides merit for the continuation of the project into Phase II. For the Phase II project we propose the following Specific Aims: (1) Optimization of the telemetric pressure sensor; (2) Demonstration of a wearable reader unit to record and display pressure measurements; and (3) Performance of an in vivo preclinical study.

Public Health Relevance

More than 3 million Americans and 60 million people worldwide have glaucoma. Glaucoma is the second leading cause of blindness in the world and accounts for nearly $3B in direct medical costs per year in the U.S. The ultimate goal of the proposed SBIR project is to apply novel technologies to develop a miniature device for glaucoma treatment.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44EY025463-02
Application #
9777342
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Wujek, Jerome R
Project Start
2015-09-30
Project End
2021-08-31
Budget Start
2019-09-30
Budget End
2020-08-31
Support Year
2
Fiscal Year
2019
Total Cost
Indirect Cost
Name
H-Cubed, Inc.
Department
Type
DUNS #
136949794
City
Olmsted Falls
State
OH
Country
United States
Zip Code
44138