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

Not Applicable

• Conditions: Cataract Surgery
• Interventions: Device: miCOR System; Device: Phaco Subject Cohort

• Registration Number: NCT05729477
• Lead Sponsor: Carl Zeiss Meditec, Inc.

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.

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 Timeline

• Study First Submitted: 2022-11-08
• Study Start: 2022-12-06
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2025-10
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 375

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 2 miCOR System Subject Cohort	miCOR System	The Group 2 MICOR System subject cohort, non-use of miLOOP will enroll subsequently with up to 250 eyes total.
Group 3 miCOR System Subject Cohort	miCOR System	The Group 3 MICOR System subject cohort, use of miLOOP optional will enroll subsequently with up to 250 eyes total.
Group 1 Phaco Subject Cohort	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.

Primary Outcome Measures

Name	Time	Method
UCVA Measurement	1 day postoperative	The visual acuity measurement after cataract surgery

Trial Locations

Locations (6)

Penn State Health Eye Center; 🇺🇸 Hershey, Pennsylvania, United States

Argus Research at Cape Coral Eye Center; 🇺🇸 Cape Coral, Florida, United States

Mittleman Eye; 🇺🇸 West Palm Beach, Florida, United States

Wolfe Eye Clinic; 🇺🇸 Hiawatha, Iowa, United States

Virginia Eye Consultants; 🇺🇸 Norfolk, Virginia, United States

The eye Centers of Racine and Kenosh; 🇺🇸 Racine, Wisconsin, United States