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Device
Phacoemulsification vs miCOR System for Cataract Surgery
N/A
Waitlist Available
Research Sponsored by Carl Zeiss Meditec, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with a cataract grade of 1 to 4+ and are scheduled to undergo cataract surgery.
Subjects ≥ 18 years of age.
Must not have
Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all adverse events will be followed for 1 month
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two ways of cataract surgery: using high-frequency energy and a device with low-energy and a micro port to remove the lens.
Who is the study for?
This trial is for adults over 18 with cataract grades 1 to 4+ who are scheduled for surgery. Participants must understand the study, follow instructions, and attend follow-up visits. Those with compromised eyes or undergoing other eye surgeries, pregnant women, or those in another trial within the last month can't join.
What is being tested?
The study compares traditional phacoemulsification using high-frequency energy for cataract removal against a new MICOR System device that uses low-energy and a special port to remove the lens during routine cataract surgery.
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include discomfort at the surgical site, inflammation, infection risk post-surgery, visual disturbances like blurriness or glare, and rare cases of more serious complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a cataract graded between 1 to 4+ and will have surgery for it.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not been in any clinical trials for the last 30 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ all adverse events will be followed for 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all adverse events will be followed for 1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
UCVA Measurement
Other study objectives
Rate of intraoperative and postoperative adverse events.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: Group 1 Phaco Subject CohortActive Control1 Intervention
The Group 1 Phaco subject cohort will begin enrolling subjects sequentially in the first initial arm of the study with up to 250 eyes total.
Group II: Group 2 miCOR System Subject CohortActive Control1 Intervention
The Group 2 MICOR System subject cohort, non-use of miLOOP will enroll subsequently with up to 250 eyes total.
Group III: Group 3 miCOR System Subject CohortActive Control1 Intervention
The Group 3 MICOR System subject cohort, use of miLOOP optional will enroll subsequently with up to 250 eyes total.
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Who is running the clinical trial?
Carl Zeiss Meditec, Inc.Lead Sponsor
22 Previous Clinical Trials
5,075 Total Patients Enrolled