Trial Outcomes & Findings for Assessment of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery (NCT NCT04747834)

Results Overview

Total lens removal time is defined in two phases: * The beginning time starts when the surgeon enters the eye with the MICOR-304 to start the lens removal process and completing when the surgeon finishes the nucleus lens removal with the MICOR-304 before changing over to irrigation and aspiration. * The second phase of lens removal time is the irrigation and aspiration stage for cortex removal which starts when the irrigation and aspiration tip enters the eye and completion time is when the cortex is removed. The total lens removal time as defined above is recorded in minutes and seconds.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

Assessed during the surgical procedure, measured in seconds.

Results posted on

2024-06-06

Participant Flow

Recruitment began in January of 2021 and was completed in January 2022. The study had remained opened since January 2022 and was going to continue recruitment eventually. It was decided by the study sponsor to not enroll any more subjects and close out the study in February of 2024. Three clinical sites participated in the study.

Participant milestones

Participant milestones
Measure	Cohort 1 Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Overall Study STARTED	44	56
Overall Study COMPLETED	44	56
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=93 Participants	9 Participants n=4 Participants	29 Participants n=27 Participants
Age, Categorical >=65 years	24 Participants n=93 Participants	47 Participants n=4 Participants	71 Participants n=27 Participants
Age, Continuous	66.3 years STANDARD_DEVIATION 6.6 • n=93 Participants	70.2 years STANDARD_DEVIATION 6.2 • n=4 Participants	68.5 years STANDARD_DEVIATION 6.7 • n=27 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	30 Participants n=4 Participants	56 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	26 Participants n=4 Participants	44 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=93 Participants	54 Participants n=4 Participants	97 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	7 Participants n=93 Participants	1 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) White	36 Participants n=93 Participants	53 Participants n=4 Participants	89 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	44 participants n=93 Participants	56 participants n=4 Participants	100 participants n=27 Participants

PRIMARY outcome

Timeframe: Assessed during the surgical procedure, measured in seconds.

Total lens removal time is defined in two phases: * The beginning time starts when the surgeon enters the eye with the MICOR-304 to start the lens removal process and completing when the surgeon finishes the nucleus lens removal with the MICOR-304 before changing over to irrigation and aspiration. * The second phase of lens removal time is the irrigation and aspiration stage for cortex removal which starts when the irrigation and aspiration tip enters the eye and completion time is when the cortex is removed. The total lens removal time as defined above is recorded in minutes and seconds.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Total Lens Removal Time	76.0 seconds Interval 62.0 to 90.0	80.1 seconds Interval 66.1 to 94.1

PRIMARY outcome

Timeframe: Assessed during the surgical procedure, approximately 8 - 10 minutes.

Total irrigation solution volume will be recorded using the indicators on the bag which will have labels that have pre-defined markers to indicate milliliters (ml) of volume of irrigation solution used for the surgical procedure.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Amount of Irrigation Solution Fluid Volume Used During the Surgical Procedure	40.7 Milliliters Interval 36.0 to 45.3	35.3 Milliliters Interval 30.6 to 40.0

SECONDARY outcome

Timeframe: Assessed during the surgical procedure.

Total Surgical Procedure Time time is defined as the beginning time when the surgeon makes the first incision in the eye and completion time is when the eye speculum is removed at the end of the procedure. Total surgical procedure time is recorded in minutes and seconds.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Total Surgical Procedure Time	486.3 seconds Standard Deviation 151.7	440.0 seconds Standard Deviation 143.1

SECONDARY outcome

Timeframe: Postoperative 1 Day

Population: Some outcome measures are based on participants while other outcome measures are based on means on a unit scale

Assessment of subjects uncorrected visual acuity (UCVA) at day 1 postoperative. Visual acuity is assessed by the healthcare provider without the aid of glasses or spectacles.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
UCVA at 1-Day UCVA 20/20 @ 1-Day	14 Participants	15 Participants
UCVA at 1-Day UCVA 20/25 @ 1-Day	13 Participants	10 Participants
UCVA at 1-Day UCVA 20/30 @ 1-Day	7 Participants	8 Participants
UCVA at 1-Day UCVA 20/40 @ 1-Day	4 Participants	8 Participants
UCVA at 1-Day UCVA 20/50 @ 1-Day	3 Participants	2 Participants
UCVA at 1-Day UCVA 20/60 @ 1-Day	0 Participants	2 Participants
UCVA at 1-Day UCVA 20/70 @ 1-Day	0 Participants	5 Participants
UCVA at 1-Day UCVA 20/80 @ 1-Day	1 Participants	0 Participants
UCVA at 1-Day UCVA 20/100 @ 1-Day	0 Participants	1 Participants
UCVA at 1-Day UCVA 20/150 @ 1-Day	2 Participants	0 Participants
UCVA at 1-Day UCVA 20/200 @ 1-Day	0 Participants	3 Participants
UCVA at 1-Day UCVA 20/320 @ 1-Day	0 Participants	1 Participants
UCVA at 1-Day Finger Count @ 1-Day	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 1- week postoperative

Assessment of best-corrected distance visual acuity (BCDVA) at the 1-week postoperative visit. BCDVA is assessed by the healthcare provider and is a measurement of how well someone can see at 6m with corrective lenses, such as glasses or contact lenses.

Outcome measures

Outcome measures
Measure	Cohort 1 n=43 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=55 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
BCDVA at 1 Week Postoperative 1-Week BCDVA 20/15	1 Participants	0 Participants
BCDVA at 1 Week Postoperative 1-Week BCDVA 20/20	30 Participants	36 Participants
BCDVA at 1 Week Postoperative 1-Week BCDVA 20/25	10 Participants	11 Participants
BCDVA at 1 Week Postoperative 1-Week BCDVA 20/30	2 Participants	6 Participants
BCDVA at 1 Week Postoperative 1-Week BCDVA 20/50	0 Participants	1 Participants
BCDVA at 1 Week Postoperative 1-Week BCDVA 20/150	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 month postoperative

Assessment of BCDVA at the 1 Month postoperative visit

Outcome measures

Outcome measures
Measure	Cohort 1 n=43 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=55 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
BCDVA at 1 Month Postoperative 1-Month BCDVA 20/15	2 Participants	3 Participants
BCDVA at 1 Month Postoperative 1-Month BCDVA 20/20	31 Participants	35 Participants
BCDVA at 1 Month Postoperative 1-Month BCDVA 20/25	8 Participants	10 Participants
BCDVA at 1 Month Postoperative 1-Month BCDVA 20/30	1 Participants	6 Participants
BCDVA at 1 Month Postoperative 1-Month BCDVA 20/40	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Measured at Baseline, 1 Day, 1 Week and 1 Month postoperative.

Assessment in the mean change in corneal thickness from baseline exam through the end of the study. Corneal thickness is measured using pachymetry presented with unit of measure "μm".

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Change in Corneal Thickness Preoperative Corneal Thickness	542.9 μm Standard Deviation 30.8	540.2 μm Standard Deviation 29.7
Change in Corneal Thickness 1 Day Corneal Thickness	620.5 μm Standard Deviation 108.2	641.1 μm Standard Deviation 210.4
Change in Corneal Thickness 1 Week Corneal Thickness	559.4 μm Standard Deviation 43.6	563.0 μm Standard Deviation 43.5
Change in Corneal Thickness 1 Month Corneal Thickness	549.1 μm Standard Deviation 40.2	543.1 μm Standard Deviation 32.1

SECONDARY outcome

Timeframe: Pre-operative

Population: Preoperative Corneal Edema

Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Corneal Edema 0 Corneal Edema	44 Participants	56 Participants
Corneal Edema Corneal Edema >0	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 Day Postoperative

Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Corneal Edema 1 Day Postoperative Postoperative 1-Day No Corneal Edema	27 Participants	18 Participants
Corneal Edema 1 Day Postoperative Postoperative 1-Day Mild Corneal Edema	8 Participants	19 Participants
Corneal Edema 1 Day Postoperative Postoperative 1-Day Moderate Corneal Edema	8 Participants	16 Participants
Corneal Edema 1 Day Postoperative Postoperative 1-Day Severe Corneal Edema	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 1-Week Postoperative

Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Corneal Edema 1-Week Postoperative Postoperative 1-Week No Corneal Edema	43 Participants	53 Participants
Corneal Edema 1-Week Postoperative Postoperative 1-Week Mild Corneal Edema	1 Participants	2 Participants
Corneal Edema 1-Week Postoperative Postoperative 1-Week Severe Corneal Edema	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 Month Postoperative

Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe

Outcome measures

Outcome measures
Measure	Cohort 1 n=43 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=55 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Corneal Edema 1 Month Postoperative No Corneal Edema	43 Participants	55 Participants
Corneal Edema 1 Month Postoperative > 0 Corneal Edema	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-operative

Population: Preoperative \>1 Corneal Cells

Corneal cells will be assessed as the following: 0=\>1 cell, 0.5+=1-5 cells, 1+=6-15 cells, 2+=16-25 cells, 3+=26-50 cells and 4+=\>50 cells.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Corneal Cells 0 Corneal Cells	44 Participants	56 Participants
Corneal Cells > 0 Corneal Cells	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 Day Postoperative

Corneal cells will be assessed as the following: 0=\>1 cell, 0.5+=1-5 cells, 1+=6-15 cells, 2+=16-25 cells, 3+=26-50 cells and 4+=\>50 cells

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Corneal Cells Postoperative 1 Day >1 Corneal Cells	10 Participants	15 Participants
Corneal Cells Postoperative 1 Day 1-5 Corneal Cells	15 Participants	9 Participants
Corneal Cells Postoperative 1 Day 6-15 Corneal Cells	17 Participants	28 Participants
Corneal Cells Postoperative 1 Day 16-25 Corneal Cells	1 Participants	4 Participants
Corneal Cells Postoperative 1 Day 26-50 Corneal Cells	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 1-Week Postoperative

Corneal cells will be assessed as the following: 0=\>1 cell, 0.5+=1-5 cells, 1+=6-15 cells, 2+=16-25 cells, 3+=26-50 cells and 4+=\>50 cells

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Corneal Cells Postoperative 1-Week 1-5 Corneal Cells	3 Participants	7 Participants
Corneal Cells Postoperative 1-Week >1 Corneal Cell	38 Participants	47 Participants
Corneal Cells Postoperative 1-Week 6-15 Corneal Cells	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 1-Month Postoperative

Corneal cells will be assessed as the following: 0=\>1 cell, 0.5+=1-5 cells, 1+=6-15 cells, 2+=16-25 cells, 3+=26-50 cells and 4+=\>50 cells

Outcome measures

Outcome measures
Measure	Cohort 1 n=43 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=55 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Corneal Cells Postoperative 1-Month 0 Corneal Cells	43 Participants	55 Participants
Corneal Cells Postoperative 1-Month >1 Corneal Cells	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-operative

Anterior chamber flare will be assessed as the following: 0-None, 1+=Faint, 2+=Moderate, (iris and lens details clear), 3+=Marked (iris and lens details hazy), 4+=Intense fibrin or plastic aqueous.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Anterior Chamber Flare Preoperative 0 Anterior Chamber Flare	44 Participants	56 Participants
Anterior Chamber Flare Preoperative >0 Anterior Chamber Flare	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1-Day Postoperative

Anterior chamber flare will be assessed as the following: 0-None, 1+=Faint, 2+=Moderate, (iris and lens details clear), 3+=Marked (iris and lens details hazy), 4+=Intense fibrin or plastic aqueous.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Anterior Chamber Flare Postoperative 1 Day 0 Anterior Chamber Flare	41 Participants	51 Participants
Anterior Chamber Flare Postoperative 1 Day Faint Anterior Chamber Flare	3 Participants	5 Participants

SECONDARY outcome

Timeframe: 1-Week Postoperative

Anterior chamber flare will be assessed as the following: 0-None, 1+=Faint, 2+=Moderate, (iris and lens details clear), 3+=Marked (iris and lens details hazy), 4+=Intense fibrin or plastic aqueous.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Anterior Chamber Flare Postoperative 1 Week 0 Anterior Chamber Flare	44 Participants	56 Participants
Anterior Chamber Flare Postoperative 1 Week >0 Anterior Chamber Flare	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1-Month Postoperative

Anterior chamber flare will be assessed as the following: 0-None, 1+=Faint, 2+=Moderate, (iris and lens details clear), 3+=Marked (iris and lens details hazy), 4+=Intense fibrin or plastic aqueous.

Outcome measures

Outcome measures
Measure	Cohort 1 n=43 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=55 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Anterior Chamber Flare Postoperative 1 Month 0 Anterior Chamber Flare	43 Participants	55 Participants
Anterior Chamber Flare Postoperative 1 Month >0 Anterior Chamber Flare	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-operative

Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Posterior Capsule Opacification Preoperative 0 Posterior Capsule Opacification	44 Participants	56 Participants
Posterior Capsule Opacification Preoperative >0 Posterior Capsule Opacification	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1-Day Postoperative

Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Posterior Capsule Opacification Postoperative 1 Day 0 Posterior Capsule Opacification	44 Participants	56 Participants
Posterior Capsule Opacification Postoperative 1 Day >0 Posterior Capsule Opacification	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1-Week Postoperative

Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Posterior Capsule Opacificaiton Postoperative 1 Week 0 Posterior Capsule Opacification	43 Participants	56 Participants
Posterior Capsule Opacificaiton Postoperative 1 Week Minimal Posterior Capsule Opacification	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 1-Month Postoperative

Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.

Outcome measures

Outcome measures
Measure	Cohort 1 n=43 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=55 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Posterior Capsule Opacification Postoperative 1 Month 0 Posterior Capsule Opacification	39 Participants	47 Participants
Posterior Capsule Opacification Postoperative 1 Month Minimal Posterior Capsule Opacification	3 Participants	6 Participants
Posterior Capsule Opacification Postoperative 1 Month Mild Posterior Capsule Opacification	1 Participants	1 Participants
Posterior Capsule Opacification Postoperative 1 Month Moderate Posterior Capsule Opacification	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Pre-operative

Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Corneal Staining Erosion Preoperative 0 Cornea Staining Erosion	44 Participants	56 Participants
Corneal Staining Erosion Preoperative >0 Cornea Staining Erosion	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1-Day Postoperative

Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Corneal Staining Erosion Postoperative 1 Day 0 Cornea Staining Erosion	43 Participants	54 Participants
Corneal Staining Erosion Postoperative 1 Day Mild Cornea Staining Erosion	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 1-Week Postoperative

Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Corneal Staining Erosion Postoperative 1 Week 0 Cornea Staining Erosion	44 Participants	56 Participants
Corneal Staining Erosion Postoperative 1 Week >0 Cornea Staining	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1-Month Postoperative

Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe

Outcome measures

Outcome measures
Measure	Cohort 1 n=43 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=55 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Corneal Staining Erosion Postoperative 1 Month 0 Cornea Staining	43 Participants	55 Participants
Corneal Staining Erosion Postoperative 1 Month >0 Cornea Staining	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Preoperative

Population: Other slit-lamp findings mild/moderate cohort: Chalazion Right lower eyelid, Prosthesis OS, Few RK incision OU, Anterior basement membrane dystrophy, Lasik flap. Other slit-lamp findings severe cohort: Dermatochalasis, Pterygium temporal and nasal 1/2mm

Assessment of other slit-lamp exam findings not listed on data collection form.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Other Slit-Lamp Findings Preoperative Other Slit-Lamp Findings	5 Participants	2 Participants
Other Slit-Lamp Findings Preoperative No Other Slit-Lamp Findings	39 Participants	54 Participants

SECONDARY outcome

Timeframe: 1-Day Postoperative

Population: Other slit-lamp findings mild/moderate cohort: RK incisions, anterior basement membrane dystrophy, LASIK flap, Other slit-lamp findings severe cohort: Pterygium

Assessment of other slit-lamp exam findings not listed on data collection form.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Other Slit-Lamp Findings Postoperative 1-Day other slit-lamp findings	3 Participants	1 Participants
Other Slit-Lamp Findings Postoperative 1-Day no other slit-lamp findings	41 Participants	55 Participants

SECONDARY outcome

Timeframe: 1-Week Postoperative

Population: Other slit-lamp findings mild/moderate cohort: RK incisions, anterior basement membrane dystrophy, LASIK flap, Other slit-lamp findings severe cohort: Pterygium, guttata, microcystic edema.

Assessment of other slit-lamp exam findings not listed on data collection form.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Other Slit-Lamp Findings Postoperative 1-Week Other Slit-Lamp Findings	3 Participants	3 Participants
Other Slit-Lamp Findings Postoperative 1-Week No Other Slit-Lamp Findings	41 Participants	53 Participants

SECONDARY outcome

Timeframe: 1-Month Postoperative

Population: Other slit-lamp findings mild/moderate cohort: Vitreous Prolapse and Suture OS, RK incisions, anterior basement membrane dystrophy, LASIK flap, corneal scar, Other slit-lamp findings severe cohort: Endothelial Crocodile Shagreen, Arcus OU, SPK, Pterygium, guttata, microcystic edema.

Assessment of other slit-lamp exam findings not listed on data collection form.

Outcome measures

Outcome measures
Measure	Cohort 1 n=43 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=55 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Other Slit-Lamp Findings Postoperative 1-Month Other Slit-Lamp Findings	6 Participants	5 Participants
Other Slit-Lamp Findings Postoperative 1-Month No Other Slit-Lamp Findings	37 Participants	50 Participants

SECONDARY outcome

Timeframe: Pre-operative

Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Macula Preoperative Macula Assessment Normal	38 Participants	48 Participants
Macula Preoperative Macula Assessment Abnormal	6 Participants	8 Participants

SECONDARY outcome

Timeframe: 1-Month Postoperative

Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.

Outcome measures

Outcome measures
Measure	Cohort 1 n=43 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=55 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Macula Postoperative 1-Month Macula Assessment Normal	36 Participants	51 Participants
Macula Postoperative 1-Month Macula Assessment Abormal	7 Participants	4 Participants

SECONDARY outcome

Timeframe: Pre-operative

Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Disc Appearance Preoperative Disc Assessment Normal	38 Participants	48 Participants
Disc Appearance Preoperative Disc Assessment Abnormal	6 Participants	8 Participants

SECONDARY outcome

Timeframe: 1-Month Postoperative

Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.

Outcome measures

Outcome measures
Measure	Cohort 1 n=43 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=55 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Disc Appearance Postoperative 1-Month Disc Assessment Normal	33 Participants	53 Participants
Disc Appearance Postoperative 1-Month Disc Assessment Abnormal	10 Participants	2 Participants

SECONDARY outcome

Timeframe: Pre-operative

Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Vessels Preoperative Vessel Assessment Normal	43 Participants	54 Participants
Vessels Preoperative Vessel Assessment Abnormal	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 1-Month Postoperative

Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.

Outcome measures

Outcome measures
Measure	Cohort 1 n=43 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=55 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Vessels Postoperative 1-Month Vessel Assessment Normal	43 Participants	54 Participants
Vessels Postoperative 1-Month Vessel Assessment Abnormal	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Pre-operative

Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.

Outcome measures

Outcome measures
Measure	Cohort 1 n=44 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Periphery Preoperative Periphery Assessment Normal	43 Participants	49 Participants
Periphery Preoperative Periphery Assessment Abnormal	1 Participants	7 Participants

SECONDARY outcome

Timeframe: 1-Month Postoperative

Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.

Outcome measures

Outcome measures
Measure	Cohort 1 n=43 Participants Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=55 Participants Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Periphery Postoperative 1-Month Periphery Assessment Normal	42 Participants	48 Participants
Periphery Postoperative 1-Month Periphery Assessment Abnormal	1 Participants	7 Participants

Adverse Events

Cohort 1

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Cohort 2

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=44 participants at risk Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 participants at risk Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Immune system disorders Pneumonia	0.00% 0/44 • 1-Month Nothing more applicable	1.8% 1/56 • Number of events 1 • 1-Month Nothing more applicable

Other adverse events

Other adverse events
Measure	Cohort 1 n=44 participants at risk Subjects with mild to moderate cataracts (Grade 1 to 2) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.	Cohort 2 n=56 participants at risk Subjects with moderate to dense cataracts (Grade 2+ to 3+) scheduled to undergo mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.. MICOR-304: The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
Eye disorders Study Eye - Raised IOP Requiring Treatment	11.4% 5/44 • Number of events 5 • 1-Month Nothing more applicable	12.5% 7/56 • Number of events 7 • 1-Month Nothing more applicable
Eye disorders Study Eye - Posterior Capsule Rupture	2.3% 1/44 • Number of events 1 • 1-Month Nothing more applicable	0.00% 0/56 • 1-Month Nothing more applicable
Eye disorders Study Eye -Vitreal Prolapse	2.3% 1/44 • Number of events 1 • 1-Month Nothing more applicable	0.00% 0/56 • 1-Month Nothing more applicable
Eye disorders Study Eye - Cystoid Macular Edema	2.3% 1/44 • Number of events 1 • 1-Month Nothing more applicable	0.00% 0/56 • 1-Month Nothing more applicable
Eye disorders Study Eye - Increased Inflammation	2.3% 1/44 • Number of events 1 • 1-Month Nothing more applicable	0.00% 0/56 • 1-Month Nothing more applicable
Eye disorders Study Eye - Ectropion	2.3% 1/44 • Number of events 1 • 1-Month Nothing more applicable	0.00% 0/56 • 1-Month Nothing more applicable
Eye disorders Study Eye - Dry Eye	2.3% 1/44 • Number of events 1 • 1-Month Nothing more applicable	1.8% 1/56 • Number of events 1 • 1-Month Nothing more applicable
Eye disorders Study Eye - Corneal Edema	0.00% 0/44 • 1-Month Nothing more applicable	3.6% 2/56 • Number of events 2 • 1-Month Nothing more applicable
Eye disorders Study Eye - Crocodile Shagreen	0.00% 0/44 • 1-Month Nothing more applicable	1.8% 1/56 • Number of events 1 • 1-Month Nothing more applicable
Eye disorders Study Eye - Microcystic Corneal Edema	0.00% 0/44 • 1-Month Nothing more applicable	1.8% 1/56 • Number of events 1 • 1-Month Nothing more applicable
Eye disorders Study Eye - IOL Exchange	0.00% 0/44 • 1-Month Nothing more applicable	1.8% 1/56 • Number of events 1 • 1-Month Nothing more applicable

Additional Information

Gretchen Neumann

Regulatory Pathways Group, Inc.

Phone: 19494667124

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place