AquaLumen Filtration Procedure for Glaucoma

CA
Overseen ByCarlos A Urrea, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: PLU Ophthalmic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new surgical procedure called AquaLumen for individuals with moderate to severe open-angle glaucoma, a condition that increases eye pressure and can lead to vision loss. The goal is to determine if this procedure can lower eye pressure over a year. Individuals with a history of glaucoma and a specific corneal thickness may qualify. The trial excludes those who have undergone certain eye surgeries or have specific eye conditions. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could lead to new treatment options.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the AquaLumen Filtration Procedure is safe for glaucoma patients?

Research has shown that AquaLumen is safe for lowering eye pressure in people with glaucoma. In an earlier study, patients experienced a 40% to 45% reduction in eye pressure, a significant improvement over eye drops and comparable to other surgeries. Importantly, the treatment also greatly reduced the need for medications. Before the procedure, most patients used about three medications, but after 12 months, this number dropped to less than one. Many patients no longer needed medications soon after the treatment. These results suggest that AquaLumen is generally well-tolerated by patients.12345

Why are researchers excited about this trial?

Unlike the standard glaucoma treatments, which often rely on medications to decrease eye pressure, the AquaLumen Filtration Procedure is a surgical technique designed to improve fluid drainage from the eye. This procedure stands out because it offers a potentially more permanent solution by enhancing the eye's natural fluid outflow pathways. Researchers are excited about this approach as it could reduce the need for long-term medication use, which is a common burden for patients with glaucoma. By directly addressing the drainage issue, AquaLumen has the potential to offer more consistent and lasting control of eye pressure, which is crucial in preventing vision loss.

What evidence suggests that the AquaLumen procedure is effective for glaucoma?

Research has shown that the AquaLumen procedure, which participants in this trial will undergo, can lower eye pressure by 40% to 45%. This marks a significant improvement over standard eye drops. Patients with advanced glaucoma, including those already using the strongest available medications, demonstrated these results. The treatment has matched the effectiveness of other surgeries, suggesting that AquaLumen could be a strong option for managing glaucoma.12345

Are You a Good Fit for This Trial?

This clinical trial is for individuals with a condition called Open Angle Glaucoma, which increases pressure inside the eye. Participants should be those who require treatment to lower this pressure and are willing to undergo surgery.

Inclusion Criteria

Central corneal thickness between 480 and 610 microns
I have moderate to severe open angle glaucoma.

Exclusion Criteria

I have cloudy areas on my cornea.
I have had a corneal transplant surgery.
I had a trabeculectomy that did not work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Treatment

Participants undergo a surgical procedure intended to reduce intra-ocular pressure (IOP)

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surgical procedure

1 year
Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • AquaLumen
Trial Overview The study is testing a new surgical procedure called AquaLumen designed to reduce intra-ocular pressure in patients with Open Angle Glaucoma. The effectiveness and safety of this procedure will be monitored over one year.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: This is the group that will undergo the surgical treatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

PLU Ophthalmic

Lead Sponsor

Trials
1
Recruited
10+

Citations

AquaLumen™ for IOP ManagementThe first-in-human feasibility data out to 18 months show a 40% to 45% reduction in IOP—significantly outperforming topical medications and matching surgical ...
NCT06809647 | A Prospective Interventional Cohort Study ...The study will follow a group of patients with glaucoma disease that undergo a surgical procedure intended to reduce the intra-ocular pressure (IOP) for a ...
AquaLumen™ for IOP ManagementCLINICAL EFFICACY AND SAFETY​​ Importantly, these outcomes were achieved in advanced glaucoma patients, many on maximal medical therapy and with ...
A Prospective Interventional Cohort Study to Evaluate the ...The study will follow a group of patients with glaucoma disease that undergo a surgical procedure intended to reduce the intra-ocular ...
AquaLumen Filtration Procedure for GlaucomaTrial Overview The study is testing a new surgical procedure called AquaLumen designed to reduce intra-ocular pressure in patients with Open Angle Glaucoma. The ...
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