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

Cataract Surgery Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05729477
• Other study ID #: MICOR-304-102
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 6, 2022
• Est. completion date: October 2024

Study information

• Verified date: June 2024
• Source: Carl Zeiss Meditec, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 375
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery

Intervention

Device:
• miCOR System
The miCOR system is a lens fragmentation device used to break up the cataract prior to IOL implantation during cataract surgery.
• Phaco Subject Cohort
Phaco Subject Cohort

Locations

Country	Name	City	State
United States	Argus Research at Cape Coral Eye Center	Cape Coral	Florida
United States	Penn State Health Eye Center	Hershey	Pennsylvania
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	Mittleman Eye	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	UCVA Measurement	The visual acuity measurement after cataract surgery	1 day postoperative