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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-06

Study Completion Date

2026-01-31

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.

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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.

Conditions

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Cataract Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 Phaco Subject Cohort

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.

Group Type ACTIVE_COMPARATOR

Phaco Subject Cohort

Intervention Type DEVICE

Phaco Subject Cohort

Group 2 miCOR System Subject Cohort

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

Group Type ACTIVE_COMPARATOR

miCOR System

Intervention Type DEVICE

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

Group 3 miCOR System Subject Cohort

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

Group Type ACTIVE_COMPARATOR

miCOR System

Intervention Type DEVICE

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

Interventions

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miCOR System

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

Intervention Type DEVICE

Phaco Subject Cohort

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes