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Excimer Laser

Excimer Laser Trabeculostomy for Glaucoma (ELTGTS Trial)

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

Summary

This trial will test a new procedure to lower eye pressure in people with early to moderate stage primary open-angle glaucoma who are also having 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20%
Secondary outcome measures
Mean Change in medication-free DIOP from baseline

Trial Design

1Treatment groups
Experimental Treatment
Group I: ELIOS ProcedureExperimental Treatment1 Intervention
ELIOS Procedure

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.

Find a Location

Who is running the clinical trial?

ELT Sight, IncLead Sponsor
Elios Vision, Inc.Lead Sponsor
2 Previous Clinical Trials
259 Total Patients Enrolled
2 Trials studying Glaucoma
259 Patients Enrolled for Glaucoma
Iqbal (Ike) Ahmed, MDStudy DirectorPrism Eye Institute
1 Previous Clinical Trials
65 Total Patients Enrolled
1 Trials studying Glaucoma
65 Patients Enrolled for Glaucoma

Media Library

ELIOS Procedure (Excimer Laser) Clinical Trial Eligibility Overview. Trial Name: NCT04899063 — N/A
Glaucoma Research Study Groups: ELIOS Procedure
Glaucoma Clinical Trial 2023: ELIOS Procedure Highlights & Side Effects. Trial Name: NCT04899063 — N/A
ELIOS Procedure (Excimer Laser) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04899063 — N/A
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