What side effects are associated with this type of intervention?

Common treatments for glaucoma that facilitate aqueous humor outflow, such as trabeculectomy, tube shunt surgery, and minimally invasive glaucoma surgeries (MIGS) like the iStent or Hydrus Microstent, can have side effects including infection, bleeding, inflammation, hypotony (excessively low IOP), cataract formation, corneal decompensation, and surgical site failure over time. Pharmacological treatments like prostaglandin analogs, beta-blockers, and carbonic anhydrase inhibitors may cause eye redness, stinging, changes in eye color, systemic effects like bradycardia, and electrolyte imbalances.

What prior FDA approvals exist?

FDA-approved treatments for glaucoma that facilitate aqueous humor outflow include prostaglandin analogs (e.g., latanoprost, bimatoprost), which increase uveoscleral outflow, and surgical options like trabeculectomy and shunt implants (e.g., Ahmed and Baerveldt implants). These treatments aim to lower intraocular pressure by enhancing fluid drainage from the eye, similar to the mechanism of the MINIject™ implant currently under study.

What other types of research exist?

Promising, novel alternatives to the MINIject™ implant for glaucoma patients include: 1) iStent inject W, a micro-invasive glaucoma surgery (MIGS) device that improves aqueous humor outflow; 2) XEN Gel Stent, a minimally invasive implant that creates a new drainage pathway; 3) Durysta, a biodegradable implant that delivers bimatoprost to lower intraocular pressure; and 4) Micropulse Transscleral Cyclophotocoagulation (MP-TSCPC), a non-invasive laser therapy that reduces intraocular pressure by targeting the ciliary body.

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Implant

MINIject™ Implant for Glaucoma (STAR-V Trial)

N/A

Waitlist Available

Research Sponsored by iSTAR Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females, 46 years of age or older

A diagnosis of primary open-angle glaucoma, who are candidates for medical therapy, laser treatment, or glaucoma-filtering surgery

Must not have

Diagnosed degenerative visual disorders

Angle closure, congenital, or secondary glaucoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a small device called the MINIject™ implant, which is designed to help lower eye pressure in people with primary open-angle glaucoma. The device works by making it easier for fluid to drain from the eye, reducing pressure and potentially preventing vision loss.

Who is the study for?

This trial is for men and women aged 46 or older with primary open-angle glaucoma who have had successful cataract surgery. It's suitable for those needing medical therapy, laser treatment, or surgery for glaucoma. People with eye inflammation, infections, degenerative visual disorders, or other types of glaucoma cannot participate.

What is being tested?

The MINIject™ Implant by iSTAR Medical is being tested to see if it can safely lower intraocular pressure in patients with primary open-angle glaucoma. The study aims to evaluate its effectiveness compared to standard treatments.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, increased eye pressure requiring additional treatment, infection risk post-surgery, and possible changes in vision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 46 years old or older.

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I have primary open-angle glaucoma and can undergo treatment or surgery.

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I'm sorry, but "Key" is not a screening criterion. It is not possible to provide a summary or rewrite without additional context. Please provide more information.

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I have had successful cataract surgery and now have an artificial lens.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a condition that is causing my vision to worsen over time.

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I have a specific type of glaucoma.

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I have a serious eye infection or inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intraocular pressure decrease

Intraocular pressure decrease (outcome 2)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Implant GroupExperimental Treatment1 Intervention

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for glaucoma primarily aim to lower intraocular pressure (IOP) to prevent optic nerve damage and preserve vision. One key mechanism is enhancing the outflow of aqueous humor, the fluid in the eye. Treatments like the MINIject™ implant facilitate this by increasing uveoscleral outflow or improving trabecular meshwork drainage. This is crucial for glaucoma patients as elevated IOP is a major risk factor for optic nerve damage, and improving fluid outflow directly reduces this pressure, thereby protecting the optic nerve and maintaining vision.

Aqueous humor dynamics associated with the phorbol ester-induced decrease in intraocular pressure in the rabbit.