OMNI Canaloplasty vs OMNI + Hydrus Stent for Cataract and Glaucoma

Recruiting at 3 trial locations

Overseen By Samantha Marshall

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ridge Eye Care

Disqualifiers: Secondary glaucoma, Uncontrolled IOP, Corneal disease, others

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

Compensation: Varies

Number of Visits: 10

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two approaches to minimally invasive glaucoma surgery (MIGS) performed during cataract surgery to determine which more effectively lowers eye pressure. One eye will undergo canaloplasty using a device called OMNI, while the other will receive canaloplasty combined with a Hydrus stent. Researchers aim to discover if these procedures can reduce eye pressure and decrease the need for eye pressure-lowering drops. Suitable participants have mild to moderate glaucoma in both eyes and plan to undergo cataract surgery. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future glaucoma treatments.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) for ocular hypotensive medications (eye pressure-lowering drops) before participation. This means you will need to stop these specific medications for a period before the trial begins.

What prior data suggests that these surgical techniques are safe for cataract and glaucoma patients?

Research shows that both OMNI canaloplasty and its combination with the Hydrus stent are well-tolerated by patients. Studies have found that OMNI canaloplasty, when used with cataract surgery, safely lowers eye pressure over time. Patients have experienced a significant decrease in eye pressure, with no major safety concerns reported.

For the combination of OMNI canaloplasty and the Hydrus stent, research indicates it is also safe. Studies show it effectively reduces eye pressure without causing serious side effects. The FDA has already approved the Hydrus stent for use with cataract surgery, supporting the safety of this method.

Overall, evidence supports the safety of both treatments in humans. They effectively lower eye pressure in people undergoing cataract surgery, with no serious issues reported in the data. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer a novel approach to managing cataract and glaucoma. The OMNI Canaloplasty technique is unique as it involves a minimally invasive procedure that enhances eye fluid drainage without the need for a permanent implant, potentially reducing the risks associated with traditional methods like trabeculectomy or tube shunts. Adding the Hydrus Stent to the OMNI Canaloplasty might further improve fluid outflow, providing another layer of pressure reduction in the eye. This combination aims to provide a more effective and safer alternative to standard care, helping to preserve vision with fewer complications.

What evidence suggests that this trial's treatments could be effective for glaucoma?

This trial will compare OMNI canaloplasty with cataract surgery to OMNI canaloplasty combined with the Hydrus stent and cataract surgery. Research has shown that OMNI canaloplasty, when performed with cataract surgery, can significantly lower eye pressure. On average, patients experienced a 34% reduction in eye pressure after 12 months. Studies also indicate that OMNI canaloplasty can help maintain eye pressure below 18 mmHg, which is crucial for managing glaucoma.

In contrast, combining OMNI canaloplasty with the Hydrus stent offers different benefits. Although the reduction in eye pressure might not be as significant as with OMNI alone, patients using the Hydrus stent required fewer glaucoma medications over time. This suggests that the Hydrus stent may help reduce the need for medication to control eye pressure. ^{1 2 3 6 7}

Who Is on the Research Team?

Douglas McGraw, DO

Principal Investigator

Ridge Eye Care

Are You a Good Fit for This Trial?

This trial is for people with mild to moderate open-angle glaucoma and age-related cataracts needing surgery. Participants should have good potential vision post-surgery, stable eye pressure without medication, and no prior significant eye procedures or diseases that could affect the study's outcome.

Inclusion Criteria

I am having cataract surgery for my age-related cataract.

I have not had eye surgery, including laser eye correction, or certain eye treatments in the last 3 months.

My glaucoma affects both eyes almost equally with minimal differences in eye nerve damage.

Exclusion Criteria

My severe nearsightedness affects medical imaging tests.

My eye's drainage angle is not narrow or abnormal.

I have a history of corneal disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Washout Period

Participants stop taking glaucoma eye drops to allow medication effects to leave the body

4 weeks

Study Treatment

Participants undergo cataract surgery with either OMNI canaloplasty alone or OMNI canaloplasty with HYDRUS microstent

1 day

2 visits (surgery center)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up exams at one day, one week, one month, six months, and one year

12 months

7 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• OMNI Canaloplasty
• OMNI Canaloplasty and Hydrus Stent

Trial Overview The study compares two surgical methods during cataract removal: one using OMNI canaloplasty alone, and the other combining OMNI canaloplasty with a Hydrus stent. It measures eye pressure and need for pressure-lowering drops before and up to one year after surgery.

How Is the Trial Designed?

Group I: OMNI canaloplasty with cataract surgery Active Control 1 Intervention

participant will undergo OMNI canaloplasty with cataract surgery in one randomized eye

Group II: OMNI canaloplasty and Hydrus with cataract surgery Active Control 2 Interventions

participant will undergo OMNI canaloplasty and Hydrus with cataract surgery in the contralateral eye

Who Is Running the Clinical Trial?

Ridge Eye Care

Lead Sponsor

Trials

1

Recruited

80+

Alcon Research

Industry Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

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 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]

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]

Citations

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

36-Month Outcomes from the Prospective GEMINI Study In fact, at 12 months, OMNI plus cataract surgery achieved a mean IOP reduction of 8.2 mmHg (−34%), comparable to what was achieved in the ...

2. 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.

3. sightsciences.com sightsciences.com/us/sight-sciences-two-year-multicenter-study-results/

Sight Sciences Two Year Multicenter Study Results Show ... Average IOP in the high baseline IOP cohort fell 31% (from 21.9 mmHg to 15.2 mmHg) at two years, which included an average reduction of 28% ...

4. tandfonline.com tandfonline.com/doi/full/10.2147/OPTH.S422132

Real-World Outcomes of Canaloplasty and Trabeculotomy ... Canaloplasty and trabeculotomy combined with cataract surgery provided effective IOP reduction for eyes with all stages of glaucoma at postoperative 12 and 24 ...

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. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2798027

Comparison of One Year Outcomes of Goniotomy and OMNI ... OMNI and standalone goniotomy effectively reduce IOP and medication dependency at 1 year, showing similar surgical success rates.

7. journals.lww.com journals.lww.com/jcrs/fulltext/2021/07000/canaloplasty_and_trabeculotomy_ab_interno_with_the.14.aspx

Canaloplasty and trabeculotomy ab interno with the OMNI... To provide safety and effectiveness outcomes 12 months postsurgically for sequential canaloplasty and trabeculotomy with the OMNI system combined with cataract ...