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ACTIVE NOT RECRUITING
NCT05949242
NA

Clinical Outcomes in Cataract Surgery With OMNI Canaloplasty vs Cataract Surgery With OMNI Canaloplasty and Hydrus Stent

Sponsor: Ridge Eye Care

View on ClinicalTrials.gov

Summary

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.

Official title: Comparison of Clinical Outcomes in Patients Undergoing Cataract Surgery With OMNI Canaloplasty vs Cataract Surgery With OMNI Canaloplasty and Hydrus Stent

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2023-04-07

Completion Date

2025-10

Last Updated

2025-04-06

Healthy Volunteers

Yes

Interventions

DEVICE

OMNI canaloplasty

OMNI device is used to catheterize Schlemm's canal for 180 degrees and perform canaloplasty. Viscoelastic is eluded upon retraction of the catheter performing viscodilation of the canal

DEVICE

Hydrus microstent

Hydrus stent is introduced into Schlemm's canal to scaffold open the canal

Locations (4)

Royo Eye Care

Marysville, California, United States

Table Mountain Eye Care

Oroville, California, United States

Ridge Eye Institute

Paradise, California, United States

Feather River Eye Care

Yuba City, California, United States