Smart Soft Contact Lenses for Monitoring Glaucoma

Indiana University

Status

Invitation-only

Conditions

Glaucoma

Treatments

Device: Bare Contact Lens

Device: Clinical IOP Measure

Device: Experimental Contact Lens Sensor

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07224542

R01EY034901 (U.S. NIH Grant/Contract)

IU-24139

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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