Cataract Surgery + Ab-interno Canaloplasty for Glaucoma

(CATALYST Trial)

Recruiting at 3 trial locations

Overseen By Mike Pickrel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Eye, Inc.

Must be taking: Ocular hypotensives

Disqualifiers: Laser trabeculoplasty, Trabeculectomy, Acute angle closure, others

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

Compensation: Varies

Number of Visits: 25

Duration: 1 day

78 Participants Needed

Trial Summary

What is the purpose of this trial?

A prospective, multicenter, randomized, single-masked, post-market clinical trial comparing cataract surgery in conjunction with ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) to cataract surgery only in patients with mild to moderate, primary open angle glaucoma. Subjects will be followed for 24 months.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should be using 1-4 ocular hypotensive medications at the screening exam, which suggests you may continue your current glaucoma medications.

What data supports the effectiveness of the treatment Cataract Surgery + Ab-interno Canaloplasty for Glaucoma?

Research shows that using the iTrack microcatheter for ab-interno canaloplasty, either alone or with cataract surgery, significantly reduces eye pressure and the need for glaucoma medications for up to 6 years. This suggests the treatment is effective in managing glaucoma. ^{1 2 3 4 5}

Is Cataract Surgery + Ab-interno Canaloplasty safe for humans?

Research shows that the combination of cataract surgery and ab-interno canaloplasty using the iTrack microcatheter is generally safe for humans, with studies reporting sustained safety and effectiveness in reducing eye pressure and medication use for up to 6 years. ^{1 3 4 5 6}

How is the treatment of cataract surgery combined with ab-interno canaloplasty unique for glaucoma?

This treatment is unique because it combines cataract surgery with ab-interno canaloplasty, a minimally invasive procedure using the iTrack microcatheter to improve fluid drainage in the eye, which helps lower eye pressure and reduce the need for glaucoma medications over the long term. ^{1 2 3 4 6}

Research Team

Norbert Koerber, MD

Principal Investigator

Augencentrum Köln Ophthalmology

Eligibility Criteria

This trial is for patients with mild to moderate primary open-angle glaucoma who also have a visually significant cataract. They must be using 1-4 eye pressure-lowering medications. People are excluded if they don't meet specific criteria set by the study.

Inclusion Criteria

My glaucoma is not severe.

I am using 1 to 4 eye pressure medications and meet the eye pressure criteria.

I have mild to moderate open angle glaucoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cataract surgery with or without ab-interno canaloplasty

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular visits (in-person) over 24 months

Treatment Details

Interventions

• Ab-interno canaloplasty using the iTrack Advance microcatheter system
• Cataract surgery
• Cataract surgery combined with ab-interno canaloplasty using the iTrack Advance microcatheter system
• Cataract surgery combined with ab-interno canaloplasty utililzing the iTrack Advance canaloplasty device

Trial Overview The study compares two procedures: one group will receive standard cataract surgery, while the other will have cataract surgery plus ab-interno canaloplasty using iTrack Advance device. It's randomized and participants are followed for 24 months.

Participant Groups

Group I: Control: Cataract surgery Experimental Treatment 1 Intervention

Cataract surgery alone

Group II: Cataract surgery combined with ab-interno canaloplasty Active Control 1 Intervention

Ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.)

Cataract surgery is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Cataract surgery for:

• Visually significant cataracts causing impaired vision
• Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)

Approved in United States as Cataract surgery for:

• Cataracts causing visual impairment
• Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)
• Preparation for vitrectomy or retinal detachment repair

Approved in Canada as Cataract surgery for:

• Visually significant cataracts
• Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)

Approved in Japan as Cataract surgery for:

• Cataracts causing visual impairment
• Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)

Approved in China as Cataract surgery for:

• Visually significant cataracts
• Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)

Approved in Switzerland as Cataract surgery for:

• Cataracts causing visual impairment
• Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)

Who Is Running the Clinical Trial?

Nova Eye, Inc.

Lead Sponsor

Trials

3

Recruited

240+

Nova Eye Medical GmbH

Industry Sponsor

Trials

2

Recruited

220+

References

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

6-Year Efficacy and Safety of iTrack Ab-interno Canaloplasty as a Standalone Procedure and Combined with Cataract Surgery in Primary Open-Angle and Pseudoexfoliative Glaucoma. [2023]

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

Long-Term Clinical and Safety Outcomes of Canaloplasty Performed across All Grades of Glaucoma Severity. [2023]

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

36-Month Effectiveness of Ab-Interno Canaloplasty Standalone versus Combined with Cataract Surgery for the Treatment of Open-Angle Glaucoma. [2022]

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

Long-term medication reduction in controlled glaucoma with iTrack ab-interno canaloplasty as a standalone procedure and combined with cataract surgery. [2022]

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

Surgical Management of Intraocular Pressure With Ab Interno Canaloplasty in Postkeratoplasty Patients: 12-Month Results. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Four-Year Efficacy and Safety of iTrack Ab-interno Canaloplasty as a Standalone Procedure and Combined with Cataract Surgery in Open-Angle Glaucoma. [2023]