Phacoemulsification vs miCOR System for Cataract Surgery

Recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carl Zeiss Meditec, Inc.

Disqualifiers: Compromised eyes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

375 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is cataract surgery using phacoemulsification or the miCOR System safe?

Phacoemulsification is generally considered safe, but there can be complications like disruption of the lens capsule during surgery. The miCOR System, which involves a device for lens disassembly, has been studied for its impact on surgery parameters, but specific safety data for this system is not detailed in the available research. ^{1 2 3 4 5}

How does the miCOR System treatment differ from other cataract surgery treatments?

The miCOR System is a novel treatment for cataract surgery that may offer a different approach compared to traditional phacoemulsification, which uses ultrasound to break up the cloudy lens. While specific details about the miCOR System are not provided, it is likely designed to improve efficiency, safety, or outcomes in cataract surgery, similar to other advanced phacoemulsification technologies. ^{6 7 8 9 10}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cataract surgery using either the phacoemulsification approach or the MICOR System device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including visual acuity measurement and recording of adverse events

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• miCOR System
• Phaco Subject Cohort

Trial Overview 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.

Participant Groups

Group I: Group 1 Phaco Subject Cohort Active Control 1 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 Cohort Active Control 1 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 Cohort Active Control 1 Intervention

The Group 3 MICOR System subject cohort, use of miLOOP optional will enroll subsequently with up to 250 eyes total.

Who Is Running the Clinical Trial?

Carl Zeiss Meditec, Inc.

Lead Sponsor

Trials

24

Recruited

5,700+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The evaluation of the risk factors for capsular complications in phacoemulsification. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Comparison of posterior capsule opacification between a 1-piece and a 3-piece microincision intraocular lens. [2012]

3. England pubmed.ncbi.nlm.nih.gov

The phacoemulsification learning curve: per-operative complications in the first 3000 cases of an experienced surgeon. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Comparative study of phacoemulsification parameters with and without nitinol filament nuclear disassembly. [2021]

5. China pubmed.ncbi.nlm.nih.gov

Cataract surgery in aged patients: phacoemulsification or small-incision extracapsular cataract surgery. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Phacoemulsification systems. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of torsional and microburst longitudinal phacoemulsification: a prospective, randomized, masked clinical trial. [2016]

8. Australia pubmed.ncbi.nlm.nih.gov

Phacoemulsification versus manual small-incision cataract surgery for age-related cataract: meta-analysis of randomized controlled trials. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Phacoemulsification devices: a consumer's update. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Comparison of phaco-chop, divide-and-conquer, and stop-and-chop phaco techniques in microincision coaxial cataract surgery. [2022]