OMNI Canaloplasty vs OMNI + Hydrus Stent for Cataract and Glaucoma

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byDouglas McGraw, DO

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ridge Eye Care

No Placebo Group

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.

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.

+5 more

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.

+4 more

Participant Groups

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.

2Treatment groups

Active Control

Group I: OMNI canaloplasty with cataract surgeryActive Control1 Intervention

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

Group II: OMNI canaloplasty and Hydrus with cataract surgeryActive Control2 Interventions

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