ELIOS Procedure for Glaucoma

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Elios Vision, Inc.

Disqualifiers: Closed-angle glaucoma, Prior eye surgery, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG)

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that participants who cannot undergo a medication washout (time without taking certain medications) in the study eye are excluded. This suggests that a washout period might be required.

What data supports the effectiveness of the ELIOS Procedure for Glaucoma treatment?

Research shows that the Excimer Laser Trabeculostomy (ELT) is effective in reducing intraocular pressure (the pressure inside the eye) in patients with glaucoma, especially when combined with cataract surgery. Studies have demonstrated long-term success and safety of this minimally invasive procedure, which helps improve fluid outflow from the eye. ^{1 2 3 4 5}

Is the ELIOS Procedure (Excimer Laser Trabeculostomy) safe for humans?

The ELIOS Procedure, also known as Excimer Laser Trabeculostomy (ELT), is generally considered safe as it is a minimally invasive surgery that uses a cold laser to reduce tissue damage. Studies have evaluated its safety when used alone or combined with cataract surgery, showing it to be a safe option for treating glaucoma and ocular hypertension. ^{1 3 4 5 6}

How is the ELIOS Procedure treatment for glaucoma different from other treatments?

The ELIOS Procedure, or Excimer Laser Trabeculostomy (ELT), is unique because it is a minimally invasive surgery that uses a cold laser to create channels in the eye's drainage system, reducing resistance to fluid outflow and lowering eye pressure. This approach minimizes tissue damage and can be combined with cataract surgery, offering a novel option compared to traditional glaucoma surgeries. ^{2 3 4 5 7}

Eligibility Criteria

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.

Inclusion Criteria

Your Shaffer angle grade is III or IV.

I am at least 45 years old.

Your CD ratio is less than or equal to 0.8.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the ELIOS procedure to reduce intraocular pressure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the ELIOS procedure

12 months

Regular visits (in-person)

Treatment Details

Interventions

• ELIOS Procedure (Procedure)

Trial Overview 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.

Participant Groups

Group I: ELIOS Procedure Experimental Treatment 1 Intervention

ELIOS Procedure

ELIOS Procedure is already approved in European Union for the following indications:

🇪🇺 Approved in European Union as ELIOS Procedure for:

• Glaucoma
• Primary Open-Angle Glaucoma (POAG)
• Ocular Hypertension (OHT)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Elios Vision Clinical Site Oklahoma City, OK

Elios Vision Clinical Site Kenosha, WI

Elios Vision Clinical Site Largo, FL

Elios Vision Clinical Site Glendale, AZ

More Trial Locations

Who Is Running the Clinical Trial?

Elios Vision, Inc. Lead Sponsor

References

1. Germany pubmed.ncbi.nlm.nih.gov

Long-term follow-up of intraocular pressure and pressure-lowering medication in patients following Excimer laser trabeculotomy. [2021] Excimer laser trabeculotomy (ELT) is a minimally invasive procedure to lower the intraocular pressure (IOP) via a photo-ablative laser that is applied to the trabecular meshwork. With this procedure, it is possible to improve the outflow of the aqueous humor. Until now, a limited number of studies examining mostly relatively small sample sizes with midterm follow-up exist. We therefore present the analysis of a large ELT cohort in a long-term follow-up.

2. Germany pubmed.ncbi.nlm.nih.gov

Long-term treatment success and safety of combined phacoemulsification plus excimer laser trabeculostomy: an 8-year follow-up study. [2022] Combined phacoemulsification plus excimer laser trabeculostomy (phaco-ELT) is a minimally invasive surgery that effectively reduces intraocular pressure (IOP) in patients with glaucoma and a concomitant diagnosis of cataract. The aim of this study was to evaluate the long-term treatment success as well as safety of phaco-ELT over an 8-year follow-up period.

3. England pubmed.ncbi.nlm.nih.gov

Current review of Excimer laser Trabeculostomy. [2022] Excimer laser trabeculostomy (ELT) is a microinvasive glaucoma surgery (MIGS) that creates multiple laser channels through the trabecular meshwork using a cold laser system, which minimizes tissue fibrosis and aids in bypassing the main area of resistance to aqueous outflow. The purpose of this review is to evaluate the current body of evidence surrounding ELT in terms of efficacy and review the safety profile of the procedure.

4. Germany pubmed.ncbi.nlm.nih.gov

[Laser surgery for glaucoma: excimer-laser trabeculotomy]. [2022] Excimer-laser trabeculotomy (ELT) is a new, minimally invasive surgical procedure for the treatment of open-angle glaucoma that can easily be combined with cataract surgery. We herein report our experience with ELT as a stand-alone procedure and ELT plus cataract surgery.

5. Spain pubmed.ncbi.nlm.nih.gov

Combined excimer laser trabeculostomy and phacoemulsification: one year follow-up real world data of a laser-based MIGS. [2021] To evaluate the efficacy and complication profile of excimer laser trabeculostomy (ELT), an emerging laser-based trabecular minimally invasive glaucoma surgery (MIGS), combined with cataract surgery in routine clinical practice.

6. Spain pubmed.ncbi.nlm.nih.gov

Real life experience following combined excimer laser trabeculostomy and phacoemulsification in eyes with ocular hypertension or mild glaucoma and cataract. [2023] To assess the efficacy and safety of combined phacoemulsification and excimer laser trabeculostomy (ELT) in eyes with cataract and mild controlled glaucoma or ocular hypertension (OHT).

7. Spain pubmed.ncbi.nlm.nih.gov

Combined excimer laser trabeculostomy and phacoemulsification: One year follow-up real world data of a laser-based MIGS. [2021] To evaluate the efficacy and complication profile of excimer laser trabeculostomy (ELT), an emerging laser-based trabecular minimally invasive glaucoma surgery (MIGS), combined with cataract surgery in routine clinical practice.