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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for cataract surgery to determine which is more effective. One method uses high-frequency energy to break up the cloudy lens, while the other employs a new device called the miCOR System, which uses low-energy techniques to remove the lens. It suits individuals with cataracts scheduled for surgery. Participants must have a noticeable cataract not severely complicated by other eye issues. As an unphased trial, this study allows patients to contribute to innovative research that could enhance cataract surgery techniques.

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.

What prior data suggests that the miCOR System device is safe for cataract surgery?

Research has shown that the miCOR System, used for cataract surgery, is generally safe. One study found that it avoids common issues with traditional methods, such as damage from ultrasound. The miCOR System does not use ultrasound, which can sometimes harm the eye's surface or cause burns. Another report indicated that significant vision loss was rare over seven years, suggesting it is well-tolerated.

The traditional method, phacoemulsification, has been used for many years and is usually well-tolerated, though it can sometimes lead to the complications the miCOR System aims to prevent.

Various studies have tested both treatments, and serious side effects have been uncommon. This suggests both are relatively safe options for those considering cataract surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the miCOR System for cataract surgery because it offers a potentially less invasive alternative to traditional phacoemulsification, which is the current standard of care. Unlike phacoemulsification, which uses ultrasound to break up the cataract, the miCOR System incorporates advanced technology that may reduce the need for ultrasound energy, thereby minimizing potential complications and speeding up recovery time. Additionally, the miCOR System's optional use of the miLOOP device could further enhance precision and safety during surgery. These features make the miCOR System a promising innovation in cataract treatment, potentially improving outcomes for patients.

What evidence suggests that this trial's treatments could be effective for cataract surgery?

This trial will compare the miCOR System with traditional phacoemulsification for cataract surgery. Research has shown that the miCOR System might offer benefits over traditional methods. One study found that the miCOR System removed the eye's lens 46 seconds faster on average than the standard technique. This system uses a gentle method to extract the lens, potentially lowering the risk of complications compared to more intense techniques. Other findings suggest that the miCOR System can reduce the time needed to remove the lens by about 24%. While more research is needed, these results indicate that the miCOR System could be a promising option for cataract surgery. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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

Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12273710/

A Prospective Single-Center Clinical Trial Comparing Short ... However, as shown in Figure 3, mean MICOR lens removal times were 46 seconds (18%) faster than phacoemulsification lens removal times (p = 0.003) ...

2. aao.org aao.org/education/editors-choice/nonultrasonic-lens-extractor-could-be-alternative-

A Nonultrasonic Lens Extractor Could Be an Alternative to ... This was a noncomparative, retrospective, consecutive case series of 51 patients (61 eyes) who underwent cataract surgery with the miCOR 700 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12220116/

Micro-interventional pre-treatment for nucleus disassembly ... Our findings demonstrate that micro-interventional pre-treatment can decrease nucleus extraction time by approximately 24%, regardless of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05729477

NCT05729477 | A Prospective Multicenter Study To Assess ... A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device.

5. crstoday.com crstoday.com/articles/sept-2024/improving-efficiency-and-patient-outcomes-with-office-based-innovations

Improving Efficiency and Patient Outcomes With Office- ... The benefits of the miCor system are noteworthy. It does not induce cavitation, and it operates with low levels of irrigation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10960914/

7-Year Efficacy and Safety of iStent inject Trabecular Micro ... Safety outcomes were favorable, with no filtration surgeries and only 4.84% of eyes experiencing clinically significant visual field loss over 7 years of follow ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=20584934&pc=HQC

MAUDE Adverse Event Report: CARL ZEISS MEDITEC ... A patient underwent cataract surgery in the left eye on (b)(6) 2024 where the micor lens fragmentation system was used to remove the cataractous lens fragments.