VisiPlate Implant for Glaucoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new implant called the VisiPlate Aqueous Shunt to treat certain types of glaucoma, a condition that can cause vision loss by damaging the optic nerve. The goal is to determine if this implant can effectively lower eye pressure in individuals with open-angle, pseudoexfoliative, or pigmentary glaucoma. Suitable candidates have eye pressure between 20 and 40 mmHg and some vision loss. The trial seeks participants who haven't undergone certain eye surgeries or have other types of glaucoma. Joining the trial could help advance treatment options for glaucoma.
As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new treatment breakthroughs.
Do I need to stop 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 VisiPlate Aqueous Shunt is safe for glaucoma patients?
Research has shown that the VisiPlate Aqueous Shunt has been tested for safety in people with glaucoma. One study found that the shunt significantly lowered eye pressure, with many patients requiring less medication after 12 months. Most patients experienced a 42.6% drop in eye pressure over the year, which is promising.
Importantly, no major reports of serious side effects have emerged so far, suggesting the treatment is generally well-tolerated. The absence of major negative effects in these studies indicates that the VisiPlate Aqueous Shunt may be safe for use in humans. However, as with any treatment, consulting a healthcare provider is always best to understand any potential risks or side effects.12345Why are researchers excited about this trial?
Unlike the standard treatments for glaucoma, which often include medications like eye drops or more invasive surgeries, the VisiPlate Aqueous Shunt introduces a novel approach by using a tiny implant to manage eye pressure. This implant works by creating a new drainage pathway for the aqueous humor, helping to reduce intraocular pressure more effectively. Researchers are excited about this treatment because it offers a less invasive option with the potential for long-term pressure control, which could mean fewer side effects and a reduced need for ongoing medication.
What evidence suggests that the VisiPlate Aqueous Shunt is effective for glaucoma?
Research has shown that the VisiPlate Aqueous Shunt effectively lowers eye pressure in patients with open-angle glaucoma. In one study, the shunt reduced eye pressure by 42.6% over 12 months. Many patients required less medication, and nearly half stopped using medication by the study's end. This device shows promise for managing glaucoma by reducing eye pressure, which can help protect vision.12345
Are You a Good Fit for This Trial?
This trial is for patients with refractory open-angle glaucoma who have an eye pressure of 20-40mmHg, a visual field mean deviation score of -3dB or worse, and specific types of glaucoma. They must have healthy conjunctiva in the target area and no history of certain eye surgeries or conditions like angle closure glaucoma.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the VisiPlate Aqueous Shunt to lower intraocular pressure
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VisiPlate Aqueous Shunt
Find a Clinic Near You
Who Is Running the Clinical Trial?
Avisi Technologies Inc.
Lead Sponsor