Excimer Laser Trabeculostomy for Glaucoma

(ELTGTS Trial)

No longer recruiting at 21 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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure called the ELIOS System, or Excimer Laser Trabeculostomy (ELT), to determine its safety and effectiveness in lowering eye pressure in individuals with primary open-angle glaucoma, particularly those also needing cataract surgery. Candidates with mild to moderate primary open-angle glaucoma who are planning cataract surgery may qualify for this trial. Participants should have a specific range of eye pressure and no history of certain eye surgeries. As an unphased trial, this study provides an opportunity to contribute to groundbreaking research that could lead to new treatment options.

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 System procedure is safe for reducing intraocular pressure in glaucoma patients?

Research has shown that the ELIOS Procedure, which uses a special laser to treat glaucoma, is generally safe. One study found it reduced eye pressure by 14.3% and described it as minimally invasive. This means it involves little cutting or stitching, easing recovery and lowering risks.

Another review found that this procedure reduced eye pressure by 20% to 40% from the starting level without requiring patients to stop other medications, suggesting it works well. Importantly, it was noted to be safe, with most people not experiencing serious side effects.

Overall, the ELIOS Procedure appears well-tolerated and effective in lowering eye pressure for those undergoing cataract surgery with mild to moderate primary open-angle glaucoma, a common type of glaucoma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Excimer Laser Trabeculostomy, using the ELIOS Procedure, is unique because it offers a minimally invasive approach to treat glaucoma, compared to the more invasive surgeries like trabeculectomy or traditional laser therapies such as Selective Laser Trabeculoplasty (SLT). Researchers are excited about this treatment because it uses a precision laser to create small openings in the eye's drainage system, potentially improving fluid outflow and reducing intraocular pressure with less risk and faster recovery time. Unlike other treatments that can have significant side effects or require frequent administration, this method could provide a more convenient and safer option for patients.

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

Research has shown that the ELIOS Procedure, which participants in this trial will receive, may help treat primary open-angle glaucoma (POAG) by reducing eye pressure. One study found that it lowered eye pressure by an average of 4.8 mm Hg, a 27.4% decrease. Another report suggested that this laser treatment is as effective, if not more so, than other minimally invasive glaucoma surgeries. Additionally, long-term results indicated a significant eye pressure reduction of 38.6% over five years. This suggests that the ELIOS Procedure could be an effective option for managing glaucoma. ^{1 2 4 5 6}

Who Is on the Research Team?

Iqbal (Ike) Ahmed, MD

Principal Investigator

Prism Eye Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

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?

ELT Sight, Inc

Lead Sponsor

Trials

1

Recruited

320+

Elios Vision, Inc.

Lead Sponsor

Trials

3

Recruited

580+

Published Research Related to This Trial

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 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]

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 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 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]

Citations

1. 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.

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. aao.org aao.org/education/current-insight/excimer-laser-trabeculostomy-effective-microinvasi

Excimer Laser Trabeculostomy: An Effective Microinvasive ... Most relevant, ELT has shown comparable long term IOP lowering results (decrease of 38.6% after 5 years) to significantly more invasive and risk ...

4. clinicaltrial.be clinicaltrial.be/en/details/43626?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&not_yet_recruiting=0&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

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 ...

5. 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 ...

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

Current review of Excimer laser Trabeculostomy - PMC Overall studies showed moderate intraocular pressure (IOP) lowering of between 20% and 40% from baseline without medication washout and mostly a ...