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

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

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.

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.

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 Group 1 Phaco subject cohort will begin enrolling subjects sequentially in the first initial arm of the study with up to 250 eyes total.

The Group 2 MICOR System subject cohort, non-use of miLOOP will enroll subsequently with up to 250 eyes total.

The Group 3 MICOR System subject cohort, use of miLOOP optional will enroll subsequently with up to 250 eyes total.

The miCOR system is a lens fragmentation device used to break up the cataract prior to IOL implantation during cataract surgery.

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.