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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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05729477
Study type Interventional
Source Carl Zeiss Meditec, Inc.
Contact
Status Enrolling by invitation
Phase N/A
Start date December 6, 2022
Completion date October 2024
View Details
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