Glaucoma
Conditions
Keywords
glaucoma, contact lens, sensor, eye pressure, IOP, optometry, ophthalmology
Brief summary
This study is exploring the effectiveness and safety of soft contact lenses with embedded sensors, called smart contact lenses. Smart contact lenses are used to measure the pressure inside the eye.
Detailed description
Subjects first present for a single qualification visit (phase 1), then present for up to 3 short-term (\ 1 hour) in-clinic visits (phase 2), and finally have visits prior to and following a full day (phase 3). Efficacy outcomes of the smart contact lens are compared to standard clinical measures of eye pressure. Safety outcomes of the smart contact lens are compared to those of traditional soft contact lenses.
Interventions
DEVICEBare Contact Lens
Commercially available contact lens without a sensor
DEVICEExperimental Smart Contact Lens
Sensor contact lens being studied
DEVICECommercially available smart contact lens
The Triggerfish ocular monitoring system includes a disposable silicone soft contact lens with an embedded sensor, a wireless antenna, and a portable recorder.
Sponsors
Indiana University
National Eye Institute (NEI)
Purdue University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Glaucomatous Arm Inclusion Criteria * 22+ years of age * Able to wear soft contact lenses * Previously diagnosed, currently pharmaceutically treated Primary Open Angle Glaucoma (POAG) Non-Glaucomatous (Healthy Older Adults) Arm Inclusion Criteria * 22+ years of age * Able to wear soft contact lenses * Without glaucomatous disease
Exclusion criteria
for all arms: * Unable to complete the study procedures * Ocular disease other than glaucoma (if applicable) * Significant acute or chronic medical, neurologic, or other illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study and/or is contradicted for soft contact lens or sensor lens use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Goldmann Applanation Intraocular Pressure | Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days | The IOP of participants will be measured with the Goldmann applanation tonometry (GAT) prior to and following device use, and in the contralateral eye during device use. A \>2 mmHg difference in is considered clinically significantly different. |
| I-Care Tonometry Intraocular Pressure | Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days | The I-Care (I-Care, Inc.) tonometry will also be evaluated during contralateral eye device use. A \>2 mmHg difference in is considered clinically significantly different. |
| Lens comfort | Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days | Participant-reported comfort will be assessed using a simple 100-point numeric scale where a rating of '100' represents extremely uncomfortable/intolerable and a rating of '1' perfectly comfortable/not noticeable at all. Comfort assessments will occur prior to, during, and following all device use to allow comparisons to typical or comparator devices. A 7-point difference in ratings is considered clinically significantly different. |
| Lens Fit | Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days | Lens fit will be measured with slit lamp during lens wear and graded using the Cornea and Contact Lens Research Unit (CCLRU) grading scale, which ranges from 0 to 4 with a rating of 0 representing an optimal outcome. A difference of 1.0 grading unit will be considered clinically significant. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPete S Kollbaum
Indiana University
Outcome results
None listed