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

NCT05949242 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-04-06

No results posted yet for this study

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.

Conditions

  • Glaucoma, Open-Angle

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

Sponsors & Collaborators

  • Alcon Research

    collaborator INDUSTRY

  • Ridge Eye Care

    lead OTHER

Principal Investigators

  • Douglas McGraw, DO · Ridge Eye Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-07
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05949242 on ClinicalTrials.gov