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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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 Using Low Energy Lens Extraction In Patients Undergoing Cataract Surgery

Conditions
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Cataract Surgery

Intervention / Treatment
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* Device: miCOR System
* Device: Phaco Subject Cohort


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 Phaco Subject Cohort<br>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<br>* Phaco Subject Cohort<br>|
| Active Comparator: Group 2 miCOR System Subject Cohort<br>The Group 2 MICOR System subject cohort, non-use of miLOOP will enroll subsequently with up to 250 eyes total. | Device: miCOR System<br>* The miCOR system is a lens fragmentation device used to break up the cataract prior to IOL implantation during cataract surgery.<br>|
| Active Comparator: Group 3 miCOR System Subject Cohort<br>The Group 3 MICOR System subject cohort, use of miLOOP optional will enroll subsequently with up to 250 eyes total. | Device: miCOR System<br>* The miCOR system is a lens fragmentation device used to break up the cataract prior to IOL implantation during cataract surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UCVA Measurement | The visual acuity measurement after cataract surgery | 1 day postoperative |