Smart Soft Contact Lenses for Monitoring Glaucoma

N/AEnrolling By InvitationNCT07224542

Indiana University120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

120

Conditions

Glaucoma

Interventions

Bare Contact LensDEVICE

Commercially available contact lens without a sensor

Clinical IOP MeasureDEVICE

clinical IOP

Experimental Contact Lens SensorDEVICE

Sensor contact lens being studied

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Indiana University - Clinical Optics Research Lab

Bloomington, Indiana, United States

Outcomes

Primary Outcomes

Goldmann Applanation Intraocular Pressure

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.

Time frame: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days

I-Care Tonometry Intraocular Pressure

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.

Time frame: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days

Lens comfort

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.

Time frame: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days

Lens Fit

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.

Time frame: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days

Data from ClinicalTrials.gov

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