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

Sponsor

Carl Zeiss Meditec, Inc. (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05729477

Collaborator

(none)

375

Enrollment

Locations

Arms

4.8

Anticipated Duration (Months)

62.5

Patients Per Site

Patients Per Site Per Month

Study Details

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	N/A

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

Anticipated 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.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 :

Dec 6, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 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.

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

UCVA Measurement [1 day postoperative]
The visual acuity measurement after cataract surgery

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Argus Research at Cape Coral Eye Center	Cape Coral	Florida	United States	33904
2	Mittleman Eye	West Palm Beach	Florida	United States	33409
3	Wolfe Eye Clinic	Hiawatha	Iowa	United States	52233
4	Penn State Health Eye Center	Hershey	Pennsylvania	United States	17033
5	Virginia Eye Consultants	Norfolk	Virginia	United States	23502
6	The eye Centers of Racine and Kenosh	Racine	Wisconsin	United States	53405

Sponsors and Collaborators

Carl Zeiss Meditec, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carl Zeiss Meditec, Inc.

ClinicalTrials.gov Identifier:

NCT05729477

Other Study ID Numbers:

MICOR-304-102

First Posted:

Feb 15, 2023

Last Update Posted:

Feb 15, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Feb 15, 2023