Cataract Surgery + Ab-interno Canaloplasty for Glaucoma
(CATALYST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining cataract surgery with ab-interno canaloplasty (using the iTrack Advance microcatheter system) can better assist individuals with mild to moderate open-angle glaucoma compared to cataract surgery alone. The canaloplasty employs a special device to lower eye pressure, crucial for managing glaucoma. Researchers will monitor participants for two years to evaluate treatment effectiveness. Suitable candidates have mild to moderate glaucoma, use 1 to 4 medications to lower eye pressure, and have cataracts affecting their vision. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance future glaucoma treatments.
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 prior data suggests that the iTrack Advance canaloplasty device is safe for use in cataract surgery?
Research has shown that combining cataract surgery with a procedure called ab-interno canaloplasty is generally safe for patients. One study found that using the iTrack microcatheter in this procedure effectively lowered eye pressure and reduced the need for glaucoma medications over a year, reporting no major safety concerns.
Another study supported these results, demonstrating that the procedure remained effective and well-tolerated over three years. Patients experienced lower eye pressure without significant side effects.
Overall, evidence suggests that combining cataract surgery with ab-interno canaloplasty using the iTrack device is safe and manageable for patients with mild to moderate glaucoma.12345Why are researchers excited about this trial?
Researchers are excited about the combination of cataract surgery with ab-interno canaloplasty because it offers a unique approach to treating glaucoma. Unlike standard treatments that primarily rely on eye drops or laser therapy to lower eye pressure, this method combines cataract surgery with a minimally invasive procedure using the iTrack Advance canaloplasty device. This device helps enhance fluid drainage from the eye, potentially offering a more effective and longer-lasting reduction in intraocular pressure. By integrating these two procedures, the treatment could provide dual benefits—improving vision by removing cataracts and managing glaucoma more effectively.
What evidence suggests that this trial's treatments could be effective for glaucoma?
This trial will compare cataract surgery alone with cataract surgery combined with ab-interno canaloplasty. Research has shown that combining cataract surgery with ab-interno canaloplasty can effectively lower eye pressure in people with glaucoma. One study found a significant drop in eye pressure and a reduced need for glaucoma medications over three years. This treatment uses a tiny device, the iTrack, to improve fluid drainage from the eye, thereby lowering pressure. Studies also suggest that this combination is safe and effective, making it a good option for those with mild to moderate open-angle glaucoma. Overall, the evidence supports its potential to manage glaucoma symptoms effectively.13467
Who Is on the Research Team?
Norbert Koerber, MD
Principal Investigator
Augencentrum Köln Ophthalmology
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cataract surgery with or without ab-interno canaloplasty
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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
Cataract surgery is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Visually significant cataracts causing impaired vision
- Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)
- Cataracts causing visual impairment
- Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)
- Preparation for vitrectomy or retinal detachment repair
- Visually significant cataracts
- Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)
- Cataracts causing visual impairment
- Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)
- Visually significant cataracts
- Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)
- Cataracts causing visual impairment
- Lens-induced diseases (e.g., phacomorphic glaucoma, phacolytic glaucoma)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nova Eye, Inc.
Lead Sponsor
Nova Eye Medical GmbH
Industry Sponsor