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

NCT05729477 | Terminated Results FDA Device

• 1 other identifier: MICOR-304-102
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• UCVA Measurement

  1-Day postoperative UCVA measurement using LogMAR visual acuity charts

  1 day postoperative

Other Outcomes (1)

• Rate of Intraoperative and Postoperative Adverse Events.

  All adverse events will be followed from enrollment until end of the 1-day follow-up.

Study Arms (3)

Group 1 Phaco Subject Cohort

ACTIVE COMPARATOR

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.

Device: Phaco Subject Cohort

Group 2 miCOR System Subject Cohort

ACTIVE COMPARATOR

The Group 2 MICOR System subject cohort, non-use of miLOOP will enroll subsequently with up to 250 eyes total.

Device: miCOR System

Group 3 miCOR System Subject Cohort

ACTIVE COMPARATOR

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

Device: miCOR System

Interventions

miCOR System DEVICE

The miCOR system is a lens fragmentation device used to break up the cataract prior to IOL implantation during cataract surgery.

Group 2 miCOR System Subject Cohort; Group 3 miCOR System Subject Cohort

Phaco Subject Cohort DEVICE

Phaco Subject Cohort

Group 1 Phaco Subject Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits.
• Willing and able to understand and complete the informed consent document.
• Subjects with a cataract grade of 1 to 4+ and are scheduled to undergo cataract surgery.
• Subjects ≥ 18 years of age.

You may not qualify if:

• Subjects, who in the opinion of the investigator, have "compromised" eye(s); no comorbidities and no patients undergoing concurrent corneal surgery with cataract extraction.
• Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.
• Subjects that are pregnant, lactating or planning to become pregnant during the course of the study.

Sponsors & Collaborators

• Carl Zeiss Meditec, Inc.: lead

Study Sites (6)

Argus Research at Cape Coral Eye Center

Cape Coral, Florida, 33904, United States

Location

Mittleman Eye

West Palm Beach, Florida, 33409, United States

Location

Wolfe Eye Clinic

Hiawatha, Iowa, 52233, United States

Location

Penn State Health Eye Center

Hershey, Pennsylvania, 17033, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

The eye Centers of Racine and Kenosh

Racine, Wisconsin, 53405, United States

Location

Limitations and Caveats

The study was terminated prior to trial completion. Therefore, any statistical differences between the Phaco and Micor groups should be interpreted with caution due to the largely different sample sizes.

Results Point of Contact

• Title: Gretchen Neumann
• Organization: Regulatory Pathways Group

gneumann@regulatorypathways.com

9494667124

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The miCOR System used during cataract surgery is a lens fragmentation and lens removal device which is an alternative to conventional phacoemulsification. The miCOR system has no cavitation and no thermogenic energy in the eye which can eliminate the generation of heat inside the eye while at the same time maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: February 15, 2023
• Study Start: December 6, 2022
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 14, 2026
• Results First Posted: May 14, 2026

Record last verified: 2026-03

Locations

US (6)