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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cataract Surgery
• Intervention / Treatment: Device: Phaco Subject Cohort; Device: miCOR System

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 Type: Interventional
• Enrollment (Estimated): 375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Cape Coral, Florida, United States, 33904
      • Argus Research at Cape Coral Eye Center
    • West Palm Beach, Florida, United States, 33409
      • Mittleman Eye
  • Iowa
    • Hiawatha, Iowa, United States, 52233
      • Wolfe Eye Clinic
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Eye Center
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants
  • Wisconsin
    • Racine, Wisconsin, United States, 53405
      • The eye Centers of Racine and Kenosh

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UCVA Measurement	The visual acuity measurement after cataract surgery	1 day postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of intraoperative and postoperative adverse events.	All adverse events will be recorded and followed for safety purposes.	All adverse events will be followed for 1 month

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: MICOR-304-102

Drug and device information, study documents

• 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