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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change in unmedicated intraocular pressure from baseline at 12 months
Secondary outcome measures
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
704 Previous Clinical Trials
124,431 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any patient enrollment opportunities for this clinical experiment?
"Per the details available on clinicaltrials.gov, enrollment for this research is open at present. Initially posted in April of this year and last updated in July, a search for participants is underway."
Answered by AI
In how many distinct sites is this trial currently being conducted?
"This clinical trial has 4 sites recruiting patients. These locations include Oroville, Paradise and Yuba City as well as one other site; it is essential to select the closest centre so that you may reduce your travel commitments should you choose to be enrolled in this study."
Answered by AI
How many people have been accepted as participants in this research endeavor?
"Affirmative, the details posted on clinicaltrials.gov affirm that this medical study is open for recruitment. First announced on April 7th 2023, this trial seeks to enrol 80 patients from 4 distinct sites."
Answered by AI
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