Excimer Laser Trabeculostomy for Glaucoma

(ELTGTS Trial)

Recruiting at 20 trial locations

Overseen By Rupali Nangia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ELT Sight, Inc

Must not be taking: Corticosteroids

Disqualifiers: Closed-angle glaucoma, Corneal 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: Immediate (procedure duration)

318 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of the ELIOS System, a procedure to lower eye pressure, in adults with mild to moderate primary open-angle glaucoma who are undergoing cataract surgery.

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 treatment Excimer Laser Trabeculostomy (ELT) for glaucoma?

Research shows that Excimer Laser Trabeculostomy (ELT) is a minimally invasive procedure that helps lower eye pressure by improving fluid outflow in the eye, and it can be effectively combined with cataract surgery for better results. ^{1 2 3 4 5}

Is Excimer Laser Trabeculostomy (ELT) safe for humans?

Excimer Laser Trabeculostomy (ELT) is considered a minimally invasive procedure, and studies have evaluated its safety, often in combination with cataract surgery. While the research is limited, it generally suggests that ELT is safe for treating glaucoma and ocular hypertension. ^{1 2 3 6 7}

How is the ELIOS Procedure different from other glaucoma treatments?

The ELIOS Procedure, or Excimer Laser Trabeculostomy (ELT), is unique because it uses a cold laser to create channels in the eye's drainage system, improving fluid outflow and reducing eye pressure. This minimally invasive treatment can be done alone or with cataract surgery, offering a novel approach compared to traditional surgeries that may involve more tissue damage. ^{1 2 3 4 8}

Research Team

Iqbal (Ike) Ahmed, MD

Principal Investigator

Prism Eye Institute

Eligibility Criteria

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.

Inclusion Criteria

My eye pressure is 24 mmHg or less with medication.

CD ratio <=0.8

Unmedicated diurnal IOP of >=22 mmHg and <=34 mmHg

Exclusion Criteria

I have been diagnosed with a condition that is causing my vision to worsen over time.

Non-study eye with BCVA worse than 20/80

Known corticosteroid responder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the ELIOS procedure during cataract surgery to reduce intraocular pressure

Immediate (procedure duration)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the ELIOS procedure

24 months

Regular visits (in-person)

Treatment Details

Interventions

• ELIOS Procedure

Trial Overview 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.

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?

ELT Sight, Inc

Lead Sponsor

Trials

1

Recruited

320+

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]

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]

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]

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]

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. England pubmed.ncbi.nlm.nih.gov

Current review of Excimer laser Trabeculostomy. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

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

4. 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]

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. Germany pubmed.ncbi.nlm.nih.gov

Excimer laser trabeculotomy: a new, minimally invasive procedure for patients with glaucoma. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Excimer laser trabeculotomy: minimally invasive glaucoma surgery]. [2018]