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Enrolling by invitation NCT07224542

Smart Soft Contact Lenses for Monitoring Glaucoma

No phase Interventional Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bare Contact Lens, Clinical IOP Measure, Experimental Contact Lens Sensor.
Who it may be relevant to
Registry conditions: Glaucoma. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Smart Soft Contact Lenses for Continuous 24-hour Monitoring of Intraocular Pressure in Glaucoma Care

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.

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

  • Device Bare Contact Lens
    Commercially available contact lens without a sensor
  • Device Clinical IOP Measure
    clinical IOP
  • Device Experimental Contact Lens Sensor
    Sensor contact lens being studied

Primary outcome measures

  • Goldmann Applanation Intraocular Pressure [Time frame: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days]
  • I-Care Tonometry Intraocular Pressure [Time frame: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days]
  • Lens comfort [Time frame: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days]
  • Lens Fit [Time frame: Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Indiana University - Clinical Optics Research Lab — Bloomington

Identifiers

NCT: NCT07224542 · IU-24139 · R01EY034901

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗