Cataract Surgery
Conditions
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.
Interventions
DEVICEmiCOR System
The miCOR system is a lens fragmentation device used to break up the cataract prior to IOL implantation during cataract surgery.
DEVICEPhaco Subject Cohort
Phaco Subject Cohort
Sponsors
Carl Zeiss Meditec, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UCVA Measurement | 1 day postoperative | 1-Day postoperative UCVA measurement using LogMAR visual acuity charts |
Countries
United States
Participant flow
Recruitment details
Subject recruitment began in November of 2022 thru November of 2023 at 6 clinical study sites.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 375 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Best-Corrected Visual Acuity (BCVA) LogMAR | 0.19 logMAR |
| Cataract Grade 1-1+ : : | 24 Eyes |
| Cataract Grade 2-2+ : : | 334 Eyes |
| Cataract Grade 3-3+ : : | 27 Eyes |
| Cataract Grade 4-5 : : | 0 Eyes |
| Cataract Type Brunescent : | 5 Eyes |
| Cataract Type Cortical : | 19 Eyes |
| Cataract Type Nuclear Sclerotic : | 547 Eyes |
| Cataract Type Posterior Subcapsular : | 11 Eyes |
| Manifest Refraction Spherical Equivalent | -0.91 Diopters |
| Pinhole Visual Acuity LogMAR | 0.25 logMAR |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 263 Participants |
| Region of Enrollment United States | 288 Participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 124 Participants |
| Uncorrected Visual Acuity (UCVA) LogMAR | 0.72 logMAR |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 288 | 0 / 114 |
| other Total, other adverse events | 22 / 288 | 5 / 114 |
| serious Total, serious adverse events | 0 / 288 | 0 / 114 |
Outcome results
None listed