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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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
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
726 Previous Clinical Trials
128,405 Total Patients Enrolled
Ridge Eye CareLead Sponsor
Douglas McGraw, DOPrincipal InvestigatorRidge Eye Care
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having cataract surgery for my age-related cataract.My severe nearsightedness affects medical imaging tests.I have not had eye surgery, including laser eye correction, or certain eye treatments in the last 3 months.My eye's drainage angle is not narrow or abnormal.My glaucoma affects both eyes almost equally with minimal differences in eye nerve damage.I have a history of corneal disease.I cannot perform certain eye tests accurately.I do not have major eye diseases affecting my vision.I can have one eye treated differently from the other.I have mild to moderate open angle glaucoma with a visual field mean deviation of -12 dB or better.I have glaucoma caused by another condition or injury.My eye pressure is high despite using all possible treatments.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: OMNI canaloplasty with cataract surgery
- Group 2: OMNI canaloplasty and Hydrus with cataract surgery
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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