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

• ClinicalTrials.gov Identifier: NCT05729477
• Recruitment Status: Enrolling by invitation
• First Posted: February 15, 2023
• Last Update Posted: February 15, 2023
• Sponsor: Carl Zeiss Meditec, Inc.
• Information provided by (Responsible Party): Carl Zeiss Meditec, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cataract Surgery	Device: miCOR System; Device: Phaco Subject Cohort	Not Applicable

Detailed Description:

This is prospective, multicenter, 3-arm study designed to provide longitudinal, observational, clinical outcome data for the use of traditional phacoemulsification for subjects undergoing cataract surgery versus the MICOR System device used to evacuate the lens prior to intraocular lens insertion and cataract surgery. Only FDA cleared phacoemulsification devices can be used per indications.

Both eyes of the study subjects may be enrolled into the study; however, if only 1 eye is eligible for study participation, then the eligible eye of the subject may be enrolled. Up to 750 eyes will be enrolled into one of three study groups, up to 250 subjects per group, with a maximum of 10 study centers. The 3 arms of the study groups are as follows:

• Group 1 Phaco subject cohort.
• Group 2 MICOR System subject cohort, non-use of miLOOP.
• Group 3 MICOR System subject cohort, use of miLOOP optional.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 375 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device Using Low Energy Lens Extraction In Patients Undergoing Cataract Surgery
• Actual Study Start Date: December 6, 2022
• Estimated Primary Completion Date: May 2023
• Estimated Study Completion Date: May 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Group 1 Phaco Subject Cohort; 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; Phaco Subject Cohort
Active Comparator: Group 2 miCOR System Subject Cohort; The Group 2 MICOR System subject cohort, non-use of miLOOP will enroll subsequently with up to 250 eyes total.	Device: miCOR System; The miCOR system is a lens fragmentation device used to break up the cataract prior to IOL implantation during cataract surgery.
Active Comparator: Group 3 miCOR System Subject Cohort; The Group 3 MICOR System subject cohort, use of miLOOP optional will enroll subsequently with up to 250 eyes total.	Device: miCOR System; The miCOR system is a lens fragmentation device used to break up the cataract prior to IOL implantation during cataract surgery.

Outcome Measures

Primary Outcome Measures :

1. UCVA Measurement [ Time Frame: 1 day postoperative ]
   The visual acuity measurement after cataract surgery

Other Outcome Measures:

1. Rate of intraoperative and postoperative adverse events. [ Time Frame: All adverse events will be followed for 1 month ]
   All adverse events will be recorded and followed for safety purposes.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, Florida

Argus Research at Cape Coral Eye Center

Cape Coral, Florida, United States, 33904

Mittleman Eye

West Palm Beach, Florida, United States, 33409

United States, Iowa

Wolfe Eye Clinic

Hiawatha, Iowa, United States, 52233

United States, Pennsylvania

Penn State Health Eye Center

Hershey, Pennsylvania, United States, 17033

United States, Virginia

Virginia Eye Consultants

Norfolk, Virginia, United States, 23502

United States, Wisconsin

The eye Centers of Racine and Kenosh

Racine, Wisconsin, United States, 53405

Sponsors and Collaborators

Carl Zeiss Meditec, Inc.

More Information

• Responsible Party: Carl Zeiss Meditec, Inc.
• ClinicalTrials.gov Identifier: NCT05729477
• Other Study ID Numbers: MICOR-304-102
• First Posted: February 15, 2023
• Last Update Posted: February 15, 2023
• Last Verified: February 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Cataract; Lens Diseases; Eye Diseases