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

Launched by CARL ZEISS MEDITEC, INC. · Feb 14, 2023

Keywords

ClinConnect Summary

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 e...

Gender

ALL

Eligibility criteria

• 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.