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Procedure

OMNI Canaloplasty vs OMNI + Hydrus Stent for Cataract and Glaucoma

N/A
Recruiting
Led By Douglas McGraw, DO
Research Sponsored by Ridge Eye Care
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at the effects of two different MIGS on reducing eye pressure in patients with mild to moderate glaucoma during cataract surgery.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort in the eyes, redness, inflammation, temporary increase in eye pressure or blurry vision post-surgery. Long-term risks might involve stent malposition or blockage affecting eye drainage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change in unmedicated intraocular pressure from baseline at 12 months
Secondary study objectives
percentage of patients with greater than 20% reduction in intraocular pressure from baseline
reduction in number of medications needed to control intraocular pressure from baseline

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

Alcon ResearchIndustry Sponsor
731 Previous Clinical Trials
128,829 Total Patients Enrolled
Ridge Eye CareLead Sponsor
Douglas McGraw, DOPrincipal InvestigatorRidge Eye Care

Media Library

OMNI Canaloplasty (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05949242 — N/A
Primary Open Angle Glaucoma Clinical Trial 2023: OMNI Canaloplasty Highlights & Side Effects. Trial Name: NCT05949242 — N/A
Primary Open Angle Glaucoma Research Study Groups: OMNI canaloplasty with cataract surgery, OMNI canaloplasty and Hydrus with cataract surgery
OMNI Canaloplasty (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05949242 — N/A
~31 spots leftby Nov 2025
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