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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Phaco Subject Cohort | Active Comparator | 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. |
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| Group 2 miCOR System Subject Cohort | Active Comparator | The Group 2 MICOR System subject cohort, non-use of miLOOP will enroll subsequently with up to 250 eyes total. |
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| Group 3 miCOR System Subject Cohort | Active Comparator | The Group 3 MICOR System subject cohort, use of miLOOP optional will enroll subsequently with up to 250 eyes total. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| miCOR System | Device | The miCOR system is a lens fragmentation device used to break up the cataract prior to IOL implantation during cataract surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| UCVA Measurement | 1-Day postoperative UCVA measurement using LogMAR visual acuity charts | 1 day postoperative |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Intraoperative and Postoperative Adverse Events. | All adverse events will be recorded and followed for safety purposes. | All adverse events will be followed from enrollment until end of the 1-day follow-up. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Argus Research at Cape Coral Eye Center | Cape Coral | Florida | 33904 | United States | ||
| Mittleman Eye |
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Subject recruitment began in November of 2022 thru November of 2023 at 6 clinical study sites.
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Phaco Subject Cohort | The Group 1 Phaco subject cohort will begin enrolling subjects sequentially in the first initial arm of the study. |
| FG001 | Group 2 Micor Subject Cohort |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2023 |
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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.
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| Phaco Subject Cohort | Device | Phaco Subject Cohort |
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| West Palm Beach |
| Florida |
| 33409 |
| United States |
| Wolfe Eye Clinic | Hiawatha | Iowa | 52233 | United States |
| Penn State Health Eye Center | Hershey | Pennsylvania | 17033 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| The eye Centers of Racine and Kenosh | Racine | Wisconsin | 53405 | United States |
The Group 2 Micor subject cohort will enrolling subjects subsequent to the Phaco arm of the study.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 510 eyes total. |
| BG001 | Group 3 miCOR System Subject Cohort | The Group 3 MICOR System subject cohort, use of miLOOP optional will enroll subsequently with up to 450 eyes total. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Eyes |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | Participants | Participants |
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| Cataract Type | Cataract Type was described as nuclear sclerotic, cortical, brunescent, or posterior subcapsular | Eyes | Count of Units | Eyes | Eyes |
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| Cataract Grade | Cataract grade analysis was performed for "all treated eyes." Cataract grading was as follows: Grade 1 (Mild): Early-stage, slight clouding, minimal impact on vision. Grade 2 (Moderate): Hardening begins, nucleus shows yellow/green tint. Grade 3 (Severe): Significant clouding, reduced vision, brown/yellowish lens. Grade 4 (Very Severe/Mature): Very hard, brownish-red or white lens, severe vision loss. Grade 5 (Advanced/Hyper-mature): Extremely hard lens, possibly "black" or "white", posing higher surgical risk. | The number of patients analyzed is different from the unit number of eyes. Each patient could have either 1 or 2 eyes enrolled into the study. | Count of Units | Eyes | Eyes |
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| Manifest Refraction Spherical Equivalent | Baseline manifest refraction was analyzed for all treated eyes by study subject. | Mean | Full Range | Diopters | Eyes |
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| Uncorrected Visual Acuity (UCVA) LogMAR | Uncorrected Visual Acuity (UCVA) LogMAR was analyzed for all treated eyes by study subject. | Mean | Full Range | logMAR | Eyes |
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| Best-Corrected Visual Acuity (BCVA) LogMAR | Best-Corrected Visual Acuity (BCVA) LogMAR was analyzed for all treated eyes by study subject. | Mean | Full Range | logMAR | Eyes |
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| Pinhole Visual Acuity LogMAR | Pinhole Visual Acuity LogMAR was analyzed for all treated eyes by study subject. | Mean | Full Range | logMAR | Eyes |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | UCVA Measurement | 1-Day postoperative UCVA measurement using LogMAR visual acuity charts | A total of 402 subjects were enrolled into the study, 288 Phaco subjects and 114 Micor subjects. Either one or both eyes of each subject could have been enrolled into the study. Group 1 (Phaco) enrolled 449 eyes and Group 2 (Micor) enrolled 162 eyes. | Posted | Mean | Full Range | logMAR | 1 day postoperative | Eyes | Eyes |
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| Other Pre-specified | Rate of Intraoperative and Postoperative Adverse Events. | All adverse events will be recorded and followed for safety purposes. | Posted | Number | Adverse Events | All adverse events will be followed from enrollment until end of the 1-day follow-up. | Eyes | Eyes |
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From enrollment until end of the 1-day follow-up.
All adverse events were reported in the "study" eyes only. All adverse events reported were ocular AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 Phaco Subject Cohort | The Group 1 Phaco subject cohort enrolled subjects sequentially in the first initial arm of the study. | 0 | 288 | 0 | 288 | 22 | 288 |
| EG001 | Group 2 miCOR System Subject Cohort | The Group 2 MICOR System subject cohort enrolled subsequently. | 0 | 114 | 0 | 114 | 5 | 114 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Raised Intraocular Pressure | Eye disorders | Systematic Assessment |
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| Postoperative Corneal Edema | Eye disorders | Systematic Assessment |
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| Anterior Chamber Cell and Flare | Eye disorders | Systematic Assessment |
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| Capsular Tear | Eye disorders | Systematic Assessment |
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| Retained Lens Fragment | Eye disorders | Systematic Assessment |
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| Retained Cortex | Eye disorders | Systematic Assessment |
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| Detachment Descemet's Membrane | Eye disorders | Systematic Assessment |
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The study was terminated prior to trial completion. Therefore, any statistical differences between the Phaco and Micor groups should be interpreted with caution due to the largely different sample sizes.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gretchen Neumann | Regulatory Pathways Group | 9494667124 | gneumann@regulatorypathways.com |
| Feb 17, 2026 |
| Prot_SAP_001.pdf |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Cortical : |
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| Brunescent : |
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| Posterior Subcapsular : |
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| 2-2+ : : |
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| 3-3+ : : |
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| 4-5 : : |
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| Eyes |
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