Phacoemulsification vs miCOR System for Cataract Surgery

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Carl Zeiss Meditec, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to evaluate the clinical outcomes of current phacoemulsification approaches to cataract extraction involving high-frequency thermogenic energy versus the use of the MICOR System device using low-energy segment removal with a micro-interventional irrigation/aspiration port to evacuate the lens in subjects undergoing routine cataract surgery.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

Willing and able to understand and complete the informed consent document.

I am 18 years old or older.

I have a cataract graded between 1 to 4+ and will have surgery for it.

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Exclusion Criteria

I have not been in any clinical trials for the last 30 days.

My eyes are considered compromised, but I have no other health issues and am not having eye surgery with cataract removal.

Subjects that are pregnant, lactating or planning to become pregnant during the course of the study.

Treatment Details

Interventions

miCOR System (Device)
Phaco Subject Cohort (Procedure)

Trial OverviewThe 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.

Participant Groups

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.