Smart Contact Lenses for Glaucoma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must be taking: Glaucoma medications

Disqualifiers: Ocular disease, Significant illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests smart contact lenses that measure eye pressure to help manage glaucoma, a condition affecting the eyes. The goal is to determine if these lenses are safe and effective compared to current treatments. People with primary open-angle glaucoma who already use medication and can wear soft contact lenses may be suitable candidates. Healthy older adults who can wear contact lenses without having glaucoma are also eligible to participate. As an unphased trial, this study allows participants to contribute to innovative research that could enhance glaucoma management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. Since it includes participants who are already being treated for glaucoma, you might be able to continue your current treatment, but it's best to confirm with the study team.

What prior data suggests that these smart contact lenses are safe for measuring eye pressure?

Research has shown that smart contact lenses for glaucoma are generally safe. These lenses contain sensors that monitor eye pressure. One study found they work well for continuous monitoring, even during sleep, and are very safe for users. Another report found no harm to the cornea (the eye's outer layer) after use, suggesting the lenses are well-tolerated. For those considering joining a trial, these findings offer reassurance about safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about smart soft contact lenses for glaucoma because they offer a new way to monitor and manage the condition. Unlike traditional treatments that primarily focus on reducing eye pressure with medications or surgery, these lenses continuously track intraocular pressure changes directly through the eye. This real-time monitoring can lead to more personalized and timely interventions, potentially preventing further vision loss. Additionally, the convenience of wearing contact lenses instead of remembering to take medications or undergo procedures could improve patient adherence and quality of life.

What evidence suggests that these smart contact lenses are effective for glaucoma?

This trial will evaluate the effectiveness of smart soft contact lenses in monitoring intraocular pressure (IOP) for glaucoma management. Studies have shown that these lenses effectively monitor eye pressure, demonstrating high accuracy in detecting changes compared to traditional methods. Research indicates that they can measure IOP continuously for 24 hours, even during sleep. This continuous monitoring helps detect changes in eye pressure early, which is crucial for preventing glaucoma progression. Initial findings suggest that these lenses could transform glaucoma care by providing real-time data on eye pressure. ^{1 2 3 6 7}

Who Is on the Research Team?

Pete S Kollbaum

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for adults over the age of 22 with Primary Open Angle Glaucoma (POAG) who are currently on medication, and can wear soft contact lenses. Healthy older adults without glaucoma can also participate if they meet the same criteria. People with significant illnesses or ocular diseases other than POAG, or those unable to complete study procedures cannot join.

Inclusion Criteria

I am over 22, can wear contacts, and am being treated for POAG.

I am over 22, can wear contacts, and don't have glaucoma.

Exclusion Criteria

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

I have an eye condition other than glaucoma.

I cannot complete all required study procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Qualification

Subjects present for a single qualification visit to assess initial eligibility and baseline measurements

1 day

1 visit (in-person)

Short-term In-clinic Visits

Participants undergo up to 3 short-term in-clinic visits for device testing and comparison with standard measures

3 days

3 visits (in-person)

Full Day Monitoring

Participants have visits prior to and following a full day of device use to assess efficacy and safety outcomes

Up to 14 hours on 3 days

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after device use

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smart Soft Contact Lenses

Trial Overview The study tests smart soft contact lenses that have sensors to measure eye pressure against regular clinical Intraocular Pressure (IOP) measurements and bare contact lenses without sensors. The goal is to see how effective and safe these sensor-embedded lenses are in monitoring glaucoma.

How Is the Trial Designed?

Group I: Sensor Experimental Arm Experimental Treatment 3 Interventions

Followed with device and comparator

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Purdue University

Collaborator

Trials

239

Recruited

72,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07224542

Smart Soft Contact Lenses for Monitoring Glaucoma Efficacy outcomes of the smart contact lens are compared to standard clinical measures of eye pressure. Safety outcomes of the smart contact ...

2. nature.com nature.com/articles/s41467-022-33254-4

Smart soft contact lenses for continuous 24-hour ... Here we introduce a class of smart soft contact lenses, enabling the continuous 24-hour monitoring of intraocular pressure, even during sleep.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12011977/

Enhancing glaucoma care with smart contact lenses This review explores the transformative potential of smart contact lenses equipped with continuous IOP monitoring and therapeutic capabilities.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1367048423003430

A first-in-human pilot study of a novel electrically-passive ... Gaboriau et al., reported that contact lens sensors showed high diagnostic performance in detecting glaucoma progression compared to standard methods of IOP ...

5. pubs.acs.org pubs.acs.org/doi/10.1021/acs.chemrev.3c00290

Smart Contact Lenses as Wearable Ophthalmic Devices for ... Zhang et al. reports a class of smart soft contact lenses that can continuously monitor IOP, even during sleep, to aid in glaucoma care. (247) ...

6. ctv.veeva.com ctv.veeva.com/study/smart-soft-contact-lenses-for-monitoring-glaucoma

Smart Soft Contact Lenses for Monitoring Glaucoma This study is exploring the effectiveness and safety of soft contact lenses with embedded sensors, called smart contact lenses.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0014299925001797

Treatment of glaucoma with drug-loaded contact lenses In clinical trials, glaucoma patients showed a 50% reduction in IOP and no corneal tissue destruction after wearing contact lenses. In animal ...