OMNI Surgical System for Glaucoma

(EVOLVE Trial)

No longer recruiting at 1 trial location

Overseen By Afua Ohene-Nyako, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Sight Sciences, Inc.

Must be taking: Prostaglandin analogs

Disqualifiers: Other glaucoma, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new surgical option, the OMNI Surgical System, for individuals with primary open-angle glaucoma. The goal is to determine if this surgery is superior or equivalent to the usual eye drops and medications. Participants will either undergo the surgery or continue with standard medical treatments. Individuals with primary open-angle glaucoma who have had cataract surgery and currently use specific eye drops may be suitable for this trial. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

Do I have to stop taking my current medications for the trial?

The trial requires participants to be on a topical prostaglandin F2 analog as monotherapy for at least 3 months before the screening. The protocol does not specify if you need to stop other medications, but it seems you must continue the prostaglandin treatment.

What is the safety track record for the OMNI Surgical System?

Research shows that the OMNI Surgical System is generally safe for treating glaucoma. Studies have found that this system provides consistent and lasting results for adults with open-angle glaucoma. As a minimally invasive procedure, it involves less cutting and is gentler on the body.

Long-term data indicate that patients treated with the OMNI system experienced positive outcomes. Specifically, the procedure helped lower eye pressure, which is crucial for managing glaucoma. Over time, the results remained stable, demonstrating the treatment's lasting effect.

Reports highlight that the treatment is well-tolerated, with no major safety concerns noted in the studies, suggesting that serious side effects are rare. The system's approval for use further supports its safety.

Overall, current research findings suggest that the OMNI Surgical System is a safe option for those with glaucoma. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the OMNI Surgical System for glaucoma because it offers a comprehensive approach by combining canaloplasty and trabeculotomy in one procedure. This system stands out because it not only helps to open up the eye's drainage canals, improving fluid outflow, but it also addresses multiple areas of resistance in the eye's drainage system. Unlike standard treatments that rely on medications like Latanoprost to lower eye pressure, the OMNI Surgical System directly targets the underlying structural issues causing high intraocular pressure, potentially reducing the need for ongoing medication use. This dual-action technique could offer more sustainable pressure reduction and better long-term outcomes for patients.

What evidence suggests that the OMNI Surgical System is effective for glaucoma?

Research shows that the OMNI Surgical System, which participants in this trial may receive, effectively treats primary open-angle glaucoma. It can significantly lower intraocular pressure, crucial for managing this condition. One study found that patients experienced a reduction in eye pressure from an average of 22.1 mmHg to between 15.1 and 16.7 mmHg after treatment. Another study confirmed that the OMNI system effectively reduces eye pressure to below 18 mmHg after 12 months. These findings suggest that the OMNI Surgical System can help manage glaucoma by improving fluid drainage in the eye. Meanwhile, another group in this trial will receive Standard Medical Care with Latanoprost and one or two adjunctive glaucoma medications. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for people who have had cataract surgery (pseudophakic patients) and are now dealing with primary open-angle glaucoma, a common type of eye pressure problem. Participants should need additional treatment despite already using eye drops for glaucoma.

Inclusion Criteria

I am 45 years old or older.

Intraocular pressure (IOP) at the Screening visit of 20 mmHg or more and not exceeding 36 mmHg

I have been using eye drops for glaucoma for at least 3 months.

Exclusion Criteria

I have not had a retinal laser procedure in the last 3 months.

I had laser eye surgery for glaucoma less than 6 months ago.

I have a type of glaucoma that is not primary open-angle.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo canaloplasty and trabeculotomy using the OMNI Surgical System or receive standard medical care with Latanoprost and adjunctive medications

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• OMNI Surgical System

Trial Overview The study is testing the OMNI Surgical System, which is a new procedure to help lower eye pressure, against standard treatments like Latanoprost and other glaucoma medications. Patients will be randomly assigned to one of these two approaches.

How Is the Trial Designed?

Group I: Surgical (OMNI Surgical System (OSS)) Active Control 1 Intervention

Canaloplasty followed by Trabeculotomy using the OMNI Surgical System.

Group II: Standard Medical Care (SMC) Active Control 1 Intervention

Standard Medical Care with Latanoprost and one or two adjunctive glaucoma medications at the discretion of the Principal Investigator

OMNI Surgical System is already approved in United States for the following indications:

Approved in United States as OMNI Surgical System for:

• Primary Open-Angle Glaucoma

Who Is Running the Clinical Trial?

Sight Sciences, Inc.

Lead Sponsor

Trials

14

Recruited

1,000+

Published Research Related to This Trial

In a study involving 81 patients with mild-to-moderate open-angle glaucoma, the OMNI system combined with cataract surgery achieved a primary success rate of 79% to 81% in reducing intraocular pressure (IOP) by at least 20% or maintaining IOP between 6 and 18 mm Hg after 12 months.

The procedure resulted in significant IOP reduction (from 21.9 to 15.1 mm Hg in higher baseline IOP group) and a decrease in the number of medications needed, with adverse events being typical for cataract surgery, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canaloplasty and trabeculotomy ab interno with the OMNI system combined with cataract surgery in open-angle glaucoma: 12-month outcomes from the ROMEO study. Hirsch, L., Cotliar, J., Vold, S., et al.[2021]

In a study of 137 patients with mild to moderate open-angle glaucoma, the combination of 360° canaloplasty and 180° trabeculotomy significantly reduced intraocular pressure (IOP) by an average of 9.0 mmHg (38%) after 6 months, with 78% of patients being medication-free.

The procedure demonstrated a favorable safety profile, with only minor adverse events reported, such as transient hyphema (4.6%) and minimal IOP elevation (2%), and no cases of vision loss or need for secondary surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study. Gallardo, MJ., Sarkisian, SR., Vold, SD., et al.[2022]

In a study of 136 patients with mild-to-moderate open-angle glaucoma, the OMNI surgical system achieved a primary success rate of 71% in reducing intraocular pressure (IOP) by at least 20% or maintaining IOP between 6 and 18 mmHg after 12 months.

The procedure significantly lowered mean IOP from 22.3 mmHg to 15.9 mmHg and reduced the average number of medications needed from 1.9 to 1.3, with mild and expected adverse events, indicating both safety and efficacy of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multicenter 12-Month Retrospective Evaluation of Canaloplasty and Trabeculotomy in Patients with Open-Angle Glaucoma: The ROMEO 2 Study. Murphy Iii, JT., Terveen, DC., Aminlari, AE., et al.[2022]

In a study of 48 pseudophakic patients with mild to moderate open-angle glaucoma, the sequential procedures of canaloplasty followed by trabeculotomy using the OMNI system achieved a primary success rate of 73% in reducing intraocular pressure (IOP) by at least 20% or maintaining IOP between 6 and 18 mmHg after 12 months.

The procedures not only significantly lowered mean IOP (from 21.8 to 15.6 mmHg) but also reduced the number of medications needed for IOP control, demonstrating both efficacy and a favorable safety profile with mostly mild adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canaloplasty and Trabeculotomy with the OMNI System in Pseudophakic Patients with Open-Angle Glaucoma: The ROMEO Study. Vold, SD., Williamson, BK., Hirsch, L., et al.[2021]

The OMNI surgical system significantly reduced intraocular pressure (IOP) in patients with mild to moderate open-angle glaucoma, with mean IOP dropping from 24.6 mmHg at baseline to 14.9 mmHg after 24 months, achieving a reduction of over 20% in all treated eyes.

Patients also experienced a substantial decrease in medication use, with 57.7% of eyes being medication-free at 24 months, and the procedure demonstrated a favorable safety profile, with most adverse events resolving spontaneously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standalone Trabeculotomy and Viscodilation of Schlemm's Canal and Collector Channels in Open-Angle Glaucoma Using the OMNI Surgical System: 24-Month Outcomes. Klabe, K., Kaymak, H.[2022]

The OMNI surgical system was successfully used to treat a 4-month-old infant with congenital glaucoma associated with Sturge-Weber syndrome, effectively controlling intraocular pressure (IOP) without additional medication over a 10-month follow-up period.

This case suggests that the OMNI system may offer advantages over traditional angle surgery techniques in managing childhood glaucomas, indicating a need for further research into its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Viscodilation of Schlemm's Canal and Collector Channels and 360° Ab-Interno Trabeculotomy for Congenital Glaucoma Associated with Sturge-Weber Syndrome. Porsia, L., Nicoletti, M.[2022]

In a study of 149 patients with mild-moderate open-angle glaucoma and cataracts, the combination of 360° canaloplasty and 180° trabeculotomy using the OMNI surgical system significantly reduced mean diurnal intraocular pressure (IOP) from 23.8 mmHg to 15.6 mmHg (a 35% reduction) over 12 months.

The procedure also led to an 80% reduction in the need for glaucoma medications, with 84.2% of eyes achieving over 20% IOP reduction and 76% maintaining IOP levels between 6-18 mmHg, all while demonstrating a strong safety profile with mostly mild and self-limited adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canaloplasty and Trabeculotomy Combined with Phacoemulsification for Glaucoma: 12-Month Results of the GEMINI Study. Gallardo, MJ., Pyfer, MF., Vold, SD., et al.[2022]

The OMNI® Surgical System for treating primary open-angle glaucoma is budget-neutral for a hypothetical US health plan covering 1 million Medicare lives, showing a total cost decrease of $35,362 over two years.

Using OMNI® without cataract surgery incurs no additional costs, while its use with cataract surgery results in minor cost savings, indicating its financial efficiency as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The budget impact of introducing the OMNI® surgical system to a United States health plan for managing mild-to-moderate primary open-angle glaucoma. Mader, G., Ghinelli, F., Torelli, F., et al.[2023]

Citations

1. sightsciences.com sightsciences.com/us/sight-sciences-announces-publication-of-a-systematic-literature-review-and-meta-analysis-showing-omni-surgical-system-achieves-clinically-significant-long-term-reductions-in-iop-and-medication/

Sight Sciences Announces Publication of a Systematic ... OMNI enables an implant-free, ab interno minimally invasive glaucoma surgery (MIGS) procedure intended to restore aqueous outflow of ...

2. ophthalmology360.com ophthalmology360.com/glaucoma/study-highlights-long-term-outcomes-of-omni-surgical-system-for-poag/

Study highlights long-term outcomes of OMNI Surgical ... Study highlights long-term outcomes of OMNI Surgical System for POAG · Intraocular Pressure: Mean baseline IOP was 22.1 mmHg, with reductions to 15.1–16.7 mmHg ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10725746/

36-Month Outcomes from the Prospective GEMINI Study GEMINI demonstrated 12-month effectiveness of canaloplasty and trabeculotomy with OMNI combined with cataract surgery for IOP and medication reduction in mild- ...

4. omnisurgical.com omnisurgical.com/

Experience the Ergo-Series of the OMNI® Surgical System The OMNI® Surgical System from Sight Sciences is the first and only glaucoma device indicated for canaloplasty followed by trabeculotomy for patients with ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/11206721251376889

Systematic review and meta-analysis of the clinical ... OMNI significantly reduced intraocular pressure (IOP) with mean IOP <18 mmHg (11.5–17.2 mmHg) at 12 months when used standalone or combined with ...

6. sightsciences.com sightsciences.com/us/sight-sciences-announces-long-term-safety-and-effectiveness/

Sight Sciences Announces Long-Term Safety and ... The data demonstrates that the OMNI Surgical System delivers safe, consistent, and durable results in adult patients with open-angle glaucoma ( ...

7. ajo.com ajo.com/article/S0002-9394(24)00581-6/fulltext

Standalone Canaloplasty and Trabeculotomy Using the ... Standalone canaloplasty and trabeculotomy provides clinically and statistically significant reductions in IOP through up to 36 months postoperatively.