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Procedure

ELIOS Procedure for Glaucoma

N/A

Recruiting

Research Sponsored by Elios Vision, Inc.

Eligibility Criteria Checklist

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

Must have

At least 45 years old

Diagnosis of mild to moderate POAG

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial tested a procedure to reduce eye pressure in those with mild-moderate glaucoma, showing it was safe and effective.

Who is the study for?

This trial is for adults at least 45 years old with mild to moderate primary open-angle glaucoma (POAG). Participants should have a Shaffer angle grade of III or IV, medicated intraocular pressure (IOP) of 24 mmHg or less, and a cup-to-disc (CD) ratio of up to 0.8.Check my eligibility

What is being tested?

The ELIOS System procedure is being tested for its ability to safely reduce eye pressure in patients with POAG. The study will assess how well the procedure works and monitor any potential complications.See study design

What are the potential side effects?

While specific side effects are not listed, typical risks may include discomfort at the site of the procedure, temporary vision changes, increased eye pressure, inflammation, or infection.

Eligibility Criteria

Inclusion Criteria

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

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I am at least 45 years old.

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

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My eye pressure is 24 mmHg or lower with medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Change in DIOP from baseline on the same or fewer medications

Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications

Trial Design

1Treatment groups

Experimental Treatment

Group I: ELIOS ProcedureExperimental Treatment1 Intervention

ELIOS Procedure

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Elios Vision, Inc.Lead Sponsor

2 Previous Clinical Trials

512 Total Patients Enrolled

2 Trials studying Glaucoma

512 Patients Enrolled for Glaucoma

Iqbal (Ike) Ahmed, MDStudy DirectorPrism Eye Institute

1 Previous Clinical Trials

318 Total Patients Enrolled

1 Trials studying Glaucoma

318 Patients Enrolled for Glaucoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research effort presently admitting participants?

"Data on clinicaltrials.gov reveals that this study is open to patient enrolment, with the initial post made on October 18th 2023 and most recently edited November 20th of the same year."

Answered by AI

What is the sample size for this research endeavor?

"Yes, according to the details listed on clinicaltrials.gov this trial is actively seeking participants. The initial posting was made on October 18th 2023 and it has recently been updated on November 20th 2023; currently 65 patients are needed from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Feasibility of the ELIOS System in POAG Patients

2023. "Safety and Feasibility of the ELIOS System in POAG Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05999006.

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