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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to look at the difference in pressure lowering effects in patients having two different combinations of minimally invasive glaucoma surgery (MIGS) at the time of their cataract surgery. Eligible patients will have mild to moderate glaucoma and be candidates for cataract surgery. The trial will look at the eye pressure before and one year after cataract surgery in patients. One eye in each patient will have cataract surgery with canaloplasty using OMNI. The patients other eye will have cataract surgery with canaloplasty and a HYDRUS stent. The trial will look at the differences in eye pressure and if patients are able to need fewer eye pressure lowering drops after surgery. Study participants will undergo preop testing of pressure, vision, slit lamp exam, ocular coherence tomography (OCT) of the nerve fiber layer (NFL) analysis, and visual field prior to cataract surgery with MIGS. One day, one week, one month, 6 month, and 1 year exams will be performed to check pressure, vision, slit lamp exam, and number of necessary eye pressure medications in each eye.

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 data supports the effectiveness of the OMNI Canaloplasty and Hydrus Stent treatment for cataract and glaucoma?

Research shows that using the OMNI system for canaloplasty and trabeculotomy, both alone and combined with cataract surgery, helps reduce eye pressure in patients with open-angle glaucoma. Additionally, the Hydrus Microstent, when used with the OMNI system, has been effective in managing glaucoma in patients who did not respond to other treatments. ^{1 2 3 4 5}

How is the OMNI Canaloplasty and Hydrus Stent treatment different from other glaucoma treatments?

The OMNI Canaloplasty and Hydrus Stent treatment is unique because it combines two procedures: canaloplasty, which involves opening the eye's drainage canal to reduce pressure, and the Hydrus Stent, a tiny tube that helps fluid drain from the eye. This combination is designed to improve fluid outflow and lower eye pressure more effectively than traditional treatments, especially in patients with open-angle glaucoma who also have cataracts. ^{1 2 3 5 6}

Research Team

Douglas McGraw, DO

Principal Investigator

Ridge Eye Care

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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 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]

References

1. United States 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Hydrus Microstent implantation with OMNI Surgical System Ab interno canaloplasty for the management of open-angle glaucoma in phakic patients refractory to medical therapy. [2022]

3. New Zealand 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of Surgical Outcomes between Canaloplasty and Schlemm's Canal Scaffold at 24 Months' Follow-Up. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Canaloplasty and Trabeculotomy Combined with Phacoemulsification for Glaucoma: 12-Month Results of the GEMINI Study. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical Results of Ab Interno Canaloplasty in Patients with Open-Angle Glaucoma. [2022]