SBIR-STTR Award

Telemetric Microsensor for Glaucoma
Award last edited on: 3/3/2021

Sponsored Program
SBIR
Awarding Agency
NIH : NEI
Total Award Amount
$974,579
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Kenneth G Goldman

Company Information

H-Cubed Inc (AKA: H-Cubed Corporation)

26988 Valeside Lane
Olmstead Falls, OH 44138
   (440) 241-1413
   info@h-cubed.com
   www.h-cubed.com
Location: Single
Congr. District: 16
County: Cuyahoga

Phase I

Contract Number: 1R43EY025463-01
Start Date: 9/30/2015    Completed: 9/29/2016
Phase I year
2015
Phase I Amount
$160,885
?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 o 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 most significant limitations of GAT are that it provides an indirect IOP measurement and only 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. As such, for the Phase I project we propose the following Specific Aims: (1) Demonstrate a low-profile micro pressure sensor with 0.5 mmHg accuracy; and (2) Establish microcoil designs on flexible substrates for wireless telemetric communication.

Public Health Relevance Statement:


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.

NIH Spending Category:
Aging; Bioengineering; Eye Disease and Disorders of Vision; Neurodegenerative; Neurosciences

Project Terms:
Accounting; Address; Affect; African American; Air; American; anterior chamber; base; Biocompatible; Blindness; Caliber; Catheters; Caucasians; Characteristics; Clinical; Communication; conjunctiva; Contact Lenses; Cornea; cost; design; Detection; Devices; Disease Management; effective therapy; Electric Capacitance; Elements; Environment; experience; Eye; Eyedrops; flexibility; Frequencies (time pattern); General Population; Glaucoma; Goals; Gold; Health; high intraocular pressure; Human Resources; Implant; implanted sensor; Individual; Lasers; Latanoprost; Length; Measurement; Measures; Mechanics; Medical; meetings; Microfabrication; microsensor; Minimally Invasive Surgical Procedures; Modality; modifiable risk; Monitor; Nerve; new technology; novel; optic nerve disorder; Pathogenesis; Patient Education; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Physicians' Offices; Physiologic Intraocular Pressure; pressure; Pressure Transducers; Property; public health relevance; radiofrequency; Reader; Reading; Retinal Ganglion Cells; Risk Factors; Saline; Sclera; Self-Administered; sensor; Signal Transduction; Small Business Innovation Research Grant; standard measure; success; System; Techniques; Technology; Telemetry; Testing; Thick; Time; Timolol; tonometry; Touch sensation; Variant; Visual Fields; Width; Wireless Technology

Phase II

Contract Number: 2R44EY025463-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2019
(last award dollars: 2020)
Phase II Amount
$813,694

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 Statement:
PROJECT NARRATIVE 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.

NIH Spending Category:
Aging; Assistive Technology; Bioengineering; Eye Disease and Disorders of Vision; Health Disparities; Neurodegenerative; Neurosciences

Project Terms:
Address; Affect; African American; American; anterior chamber; biomaterial compatibility; Blindness; Caucasians; Clinical; commercialization; conjunctiva; Contact Lenses; Cornea; Data; Data Collection; design; Devices; Disease Management; effective therapy; Elements; experience; Eye; Eyedrops; Eyeglasses; Feasibility Studies; flexibility; General Population; Glaucoma; Goals; Gold; good laboratory practice; Health; high intraocular pressure; Human Resources; Implant; implanted sensor; improved; in vivo; individual variation; Latanoprost; Measurement; Measures; mechanical properties; Medical Care Costs; Microfabrication; microsensor; miniaturize; Minimally Invasive Surgical Procedures; Modality; Modeling; modifiable risk; Monitor; Nerve; new technology; New Zealand; optic nerve disorder; Oryctolagus cuniculus; Pathogenesis; Patient Education; Patients; Performance; Periodicity; Pharmaceutical Preparations; Pharmacotherapy; Phase; Physicians' Offices; Physiologic Intraocular Pressure; preclinical study; pressure; Process; Reader; Reading; Reproducibility; Research; Retinal Ganglion Cells; Risk Factors; Secure; Self Administration; sensor; Small Business Innovation Research Grant; standard measure; Statistical Study; Telemetry; Testing; Thick; Time; Timolol; tonometry; Variant; Visual Fields; Wireless Technology