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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure called ELIOS (Excimer Laser Trabeculostomy) to determine if it can safely lower eye pressure in individuals with mild to moderate open-angle glaucoma, a common condition that can cause vision loss. The procedure aims to manage the condition by reducing intraocular pressure (the pressure inside the eye). Suitable candidates for this trial are adults diagnosed with this specific type of glaucoma who currently manage it with medication. Participants should have a certain level of eye pressure and should not have undergone specific types of eye surgeries. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for glaucoma.

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 prior data suggests that the ELIOS Procedure is safe for reducing intraocular pressure in glaucoma patients?

Research has shown that the ELIOS Procedure is generally safe for treating glaucoma. Studies have found that this laser treatment can lower eye pressure by about 14.3%, offering promise for those seeking to reduce their eye pressure.

The ELIOS Procedure is minimally invasive, typically involving less risk and a quicker recovery than more invasive surgeries. Reports indicate a good safety record, with serious side effects being rare.

Overall, evidence suggests that the ELIOS Procedure is well-tolerated, with most patients experiencing positive results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ELIOS Procedure is unique because it offers a minimally invasive alternative for treating glaucoma. Unlike traditional treatments like eye drops or invasive surgeries, the ELIOS Procedure specifically targets the eye's drainage system to improve fluid outflow and reduce intraocular pressure, which is a key factor in managing glaucoma. Researchers are excited about this approach because it could provide a quicker recovery time and less risk of complications compared to conventional surgical methods, potentially making it a game-changer for glaucoma patients.

What evidence suggests that the ELIOS Procedure is effective for reducing intraocular pressure in glaucoma?

Studies have shown that the ELIOS Procedure, which participants in this trial will undergo, effectively lowers eye pressure in people with glaucoma. One study found that the procedure reduced eye pressure by an average of 4.8 mm Hg, or 27.4%. Another report highlights that ELIOS is as effective as or better than other similar surgeries for glaucoma. Long-term data shows that this method can reduce eye pressure by 29% to 43% over several years. These findings suggest that ELIOS could be a promising option for managing primary open-angle glaucoma. ^{1 2 3 4 6}

Who Is on the Research Team?

Iqbal (Ike) Ahmed, MD

Principal Investigator

Prism Eye Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39414626/

[Efficacy and safety of the new generation of excimer laser ... Results: The average age was 65 years. The preoperative IOP was 17.5 (± 5.3) mm Hg. The mean IOP reduction was 4.8 mm Hg (27.4%, p < 0.001) on ...

2. eliosvision.com eliosvision.com/ous/news/glaucoma-leaders-highlight-significant-effectiveness-favorable-safety-profile/

Glaucoma leaders highlight significant effectiveness and ... ELIOS Excimer Laser Trabeculostomy (ELT) was as effective or better than other forms of microinvasive glaucoma surgery (MIGS) in reducing intraocular pressure ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04899063

Excimer Laser Trabeculostomy Glaucoma Treatment Study A prospective, multicenter clinical trial designed to evaluate the safety and effectiveness of the ELIOS system to reduce intraocular pressure.

4. crstodayeurope.com crstodayeurope.com/articles/the-precision-of-an-excimer-laser-for-glaucoma-treatment/long-term-experience-with-the-elios-laser/

Long-Term Experience With the ELIOS Laser A body of real-world and prospective studies with up to 8 years of follow-up demonstrates that ELIOS can provide a significant reduction of IOP (range, 29–43%) ...

5. reviewofophthalmology.com reviewofophthalmology.com/article/laserbased-glaucoma-treatments

Laser-based Glaucoma Treatments Another study demonstrated positive phaco-Elios laser outcomes with good safety, a 14.3-percent IOP reduction and a reduction of glaucoma ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7199329/

Current review of Excimer laser Trabeculostomy - PMC Overall success was obtained in 47% of the sample with a success rate of 38% in group 1 and 63% in group 2. Seven patients (11%) required ...