Clinical trial NCT05729477: A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cataract Surgery
Lead sponsor: Carl Zeiss Meditec, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-15
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: UCVA Measurement
timeFrame: 1 day postoperative
Secondary outcomes:
Other outcomes:
measure: Rate of intraoperative and postoperative adverse events.
timeFrame: All adverse events will be followed for 1 month
Locations:
city: Cape Coral
country: United States
facility: Argus Research at Cape Coral Eye Center
state: Florida
city: West Palm Beach
country: United States
facility: Mittleman Eye
state: Florida
city: Hiawatha
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Hershey
country: United States
facility: Penn State Health Eye Center
state: Pennsylvania
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
city: Racine
country: United States
facility: The eye Centers of Racine and Kenosh
state: Wisconsin
Study officials:
References: