ELIOS Procedure for Glaucoma

Recruiting at 4 trial locations

Overseen By Rupali Nangia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Elios Vision, Inc.

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

65 Participants Needed

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}

Research Team

Iqbal (Ike) Ahmed, MD

Principal Investigator

Prism Eye Institute

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.

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

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)

Who Is Running the Clinical Trial?

Elios Vision, Inc.

Lead Sponsor

Trials

3

Recruited

580+

Findings from Research

Excimer laser trabeculotomy (ELT) is an effective minimally invasive procedure for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma and ocular hypertension, with 87% of patients undergoing combined cataract and ELT surgery avoiding further interventions after a median follow-up of 656 days.

Despite the success in reducing IOP, the study found that patients were unable to significantly reduce their IOP-lowering medication over the long term, indicating that while ELT is beneficial, it may not eliminate the need for medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of intraocular pressure and pressure-lowering medication in patients following Excimer laser trabeculotomy. Deubel, C., Böhringer, D., Anton, A., et al.[2021]

In a study of 161 eyes from 128 patients, combined phacoemulsification plus excimer laser trabeculostomy (phaco-ELT) demonstrated a long-term treatment success rate of 50.2% in maintaining intraocular pressure (IOP) at or below 21 mmHg over an 8-year follow-up period.

The procedure was found to be safe, with no serious complications reported, and it significantly reduced mean IOP from 19.3 mmHg at baseline to 15.4 mmHg after 8 years, while also decreasing the need for IOP-lowering medications and subsequent surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term treatment success and safety of combined phacoemulsification plus excimer laser trabeculostomy: an 8-year follow-up study. Riesen, M., Funk, J., Töteberg-Harms, M.[2022]

Excimer laser trabeculostomy (ELT) effectively lowers intraocular pressure (IOP) by 20% to 40% from baseline without the need for medication washout, making it a promising option for glaucoma treatment.

The procedure has a favorable safety profile, resulting in fewer complications and a reduction in the need for glaucoma medications, whether performed alone or in combination with cataract surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current review of Excimer laser Trabeculostomy. Durr, GM., Töteberg-Harms, M., Lewis, R., et al.[2022]

Excimer-laser trabeculotomy (ELT) is an effective treatment for lowering intraocular pressure (IOP) in patients with open-angle glaucoma, showing a success rate of 57% for high preoperative IOP and 41% for lower preoperative IOP when performed alone.

When combined with cataract surgery, ELT significantly improves success rates, achieving 91% success in patients with high preoperative IOP and 52% in those with lower IOP, making it a promising option for managing glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Laser surgery for glaucoma: excimer-laser trabeculotomy]. Pache, M., Wilmsmeyer, S., Funk, J.[2022]

Excimer laser trabeculostomy (ELT) combined with cataract surgery significantly reduced intraocular pressure (IOP) in patients with open-angle glaucoma, with a mean IOP decrease from 20.9 mmHg to 16.3 mmHg after one year.

The procedure also led to a substantial reduction in the need for IOP-lowering medications, with 81% of eyes being medication-free at the one-year follow-up, and it was associated with a low complication rate, indicating its safety and efficacy in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined excimer laser trabeculostomy and phacoemulsification: one year follow-up real world data of a laser-based MIGS. Moreno Valladares, A., Puerto Amorós, N., Mendez Llatas, M., et al.[2021]

The study evaluated 37 eyes undergoing combined phacoemulsification and excimer laser trabeculostomy (ELT) and found a significant reduction in intraocular pressure (IOP) from an average of 17.76 mmHg preoperatively to 15.35 mmHg at 1 year, indicating effective management of mild glaucoma or ocular hypertension.

Patients also experienced a notable decrease in the need for glaucoma medications, dropping from an average of 2.02 medications preoperatively to 1.02 at 1 year, demonstrating both efficacy and safety of the combined procedure.

NCBI (Pubmed)

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. Papa-Vettorazzi, R., Pascual, L., Moura-Coelho, N., et al.[2023]

In a study of 34 eyes from 29 patients, excimer laser trabeculostomy (ELT) combined with cataract surgery significantly reduced intraocular pressure (IOP) from an average of 20.9 mmHg to 16.3 mmHg after one year, indicating its efficacy in managing open-angle glaucoma.

The procedure also led to a substantial decrease in the need for IOP-lowering medications, with 81% of eyes being medication-free at the one-year follow-up, and only minor complications were reported, such as transient IOP spikes and hyphema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined excimer laser trabeculostomy and phacoemulsification: One year follow-up real world data of a laser-based MIGS. Moreno-Valladares, A., Puerto Amorós, N., Mendez Llatas, M., et al.[2021]

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]

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]

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

Current review of Excimer laser Trabeculostomy. [2022]

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

[Laser surgery for glaucoma: excimer-laser trabeculotomy]. [2022]

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]

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]

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]