NCT05729477

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: Carl Zeiss Meditec, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cataract Surgery

Interventions

Type	Name	Description
DEVICE	miCOR System	The miCOR system is a lens fragmentation device used to break up the cataract prior to IOL implantation during cataract surgery.
DEVICE	Phaco Subject Cohort	Phaco Subject Cohort

Timeline

• Start date: 2022-12-06
• Primary completion: 2025-10-01
• Completion: 2026-01-01
• First posted: 2023-02-15
• Last updated: 2024-10-17

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study