What side effects are associated with this type of intervention?

Common treatments for glaucoma that aim to improve fluid drainage, such as glaucoma drainage devices (GDD) and trabeculostomy, can have several side effects. These may include infection, bleeding, scarring, and hypotony (abnormally low eye pressure). Additionally, there is a risk of tube erosion or blockage in GDD procedures, and potential damage to surrounding ocular structures. Patients may also experience transient or permanent vision changes. It is important to discuss these risks with a healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several surgical and device-based treatments for glaucoma aimed at improving fluid drainage in the eye. These include trabeculectomy, which creates a new drainage pathway, and various glaucoma drainage devices like the Ahmed, Baerveldt, and Molteno implants that help to divert aqueous humor from the anterior chamber to an external reservoir. Additionally, minimally invasive glaucoma surgeries (MIGS) such as the iStent, Hydrus Microstent, and Xen Gel Stent have been approved to enhance fluid outflow with less tissue disruption compared to traditional surgeries. These treatments share a similar goal with the ELIOS System, which is currently being studied for its effectiveness in reducing intraocular pressure by improving fluid drainage.

What other types of research exist?

Promising alternatives to the ELIOS System for glaucoma treatment include: 1) EX-PRESS drainage device combined with modified trabeculectomy, which has shown clinical value in reducing IOP and postoperative complications in neovascular glaucoma. 2) Ahmed glaucoma valve implantation, which is effective for treating glaucoma secondary to iridocorneal endothelial syndrome and has a good safety profile. 3) Ologen implant in trabeculectomy, which has demonstrated better bleb morphology, lower long-term postoperative IOP, and fewer complications compared to Mitomycin C in juvenile open-angle glaucoma.

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Excimer Laser

Excimer Laser Trabeculostomy for Glaucoma (ELTGTS Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for glaucoma aim to reduce intraocular pressure (IOP) to prevent optic nerve damage and preserve vision. Medications such as prostaglandin analogs and beta-blockers either increase the outflow of aqueous humor or decrease its production. Laser treatments like trabeculoplasty enhance fluid drainage through the eye's natural pathways. Surgical procedures, including the ELIOS System, create new drainage channels to improve fluid outflow. These treatments are vital for glaucoma patients as they help manage IOP, thereby reducing the risk of progressive vision loss.

N/A

Waitlist Available

Research Sponsored by ELT Sight, Inc

Eligibility Criteria Checklist

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

Must have

Medicated IOP of <=24 mmHg

At least 45 years old

Must not have

Diagnosis of degenerative visual disorders

Closed-angle and secondary glaucomas

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 month

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates the safety and effectiveness of the ELIOS System, a procedure to lower eye pressure, in adults with mild to moderate primary open-angle glaucoma who are undergoing cataract surgery.

Who is the study for?

Adults over 45 with mild to moderate primary open-angle glaucoma and cataracts can join this trial. They must have specific intraocular pressure levels, a certain angle in their eye's drainage area, and no past major eye surgeries. Pregnant or nursing women and those not using birth control are excluded.

What is being tested?

The ELIOS System procedure is being tested for its ability to lower the pressure inside the eye when combined with cataract surgery in adults with open-angle glaucoma. The study aims to assess both safety and effectiveness of this treatment.

What are the potential side effects?

Potential side effects may include discomfort at the site of operation, temporary visual disturbances, increased eye pressure post-surgery, inflammation or infection risks associated with any surgical intervention.

Eligibility Criteria

Inclusion Criteria

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

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My eye pressure is 24 mmHg or less with medication.

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I am at least 45 years old.

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I have a cataract that can be operated on, and my vision is 20/40 or worse.

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I have been diagnosed with mild to moderate open-angle glaucoma.

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 not caused by another eye condition.

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I have had surgery for glaucoma, eye, or cornea before.

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I cannot stop taking my current eye medication for the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 month

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

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20%

Secondary study objectives

Mean Change in medication-free DIOP from baseline

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: ELIOS ProcedureExperimental Treatment1 Intervention

ELIOS Procedure

0 / 8Eligibility 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

The most common treatments for glaucoma aim to reduce intraocular pressure (IOP) to prevent optic nerve damage and preserve vision. Medications such as prostaglandin analogs and beta-blockers either increase the outflow of aqueous humor or decrease its production. Laser treatments like trabeculoplasty enhance fluid drainage through the eye's natural pathways. Surgical procedures, including the ELIOS System, create new drainage channels to improve fluid outflow. These treatments are vital for glaucoma patients as they help manage IOP, thereby reducing the risk of progressive vision loss.