Cataract
Conditions
Brief summary
The purpose of this research study is to evaluate the clinical outcomes of the use of low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion in subjects undergoing routine cataract surgery.
Detailed description
Up to 300 eyes at up to 5 investigational sites will be enrolled in one of the two cohorts of this clinical investigation - up to 50 eyes in Cohort 1 and up to 50 eyes in Cohort 2. Only one eye per subject will be enrolled into the study. This is multicenter, multi-cohort, prospective clinical study designed to provide longitudinal, observational, non-comparative clinical outcome data for 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. Participants who meet the inclusion and exclusion will be asked to enroll in the study. The investigator or designee will explain the study purpose, procedures and responsibilities to the potential participant and provide sufficient opportunity to ask questions, while allowing adequate time for consideration of the information provided. Upon participant confirmation of interest, written informed consent will be obtained and the subject will be enrolled in the study. One copy of the informed consent document (ICD) will be retained with the subject's medical records and one copy will be provided to the subject. Study subjects will be stratified into two Cohorts. Cohort 1 is comprised of eyes with mild-to- moderate cataracts only (Grade 1 to 2). Cohort 2 is comprised of eyes with moderate to more dense cataracts only (Grade 2+ to 3+). Subjects will be seen at the screening visit, intraoperative visit, and at post-operative days 1, 7, and 30.
Interventions
DEVICEMICOR-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.
Sponsors
Carl Zeiss Meditec, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be stratified into two Cohorts. Cohort 1 is comprised of eyes with mild-to- moderate cataracts only (Grade 1 to 2). Cohort 2 is comprised of eyes with moderate to more dense cataracts only (Grade 2+ to 3+).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits 2. Willing and able to understand and complete the informed consent document 3. Subjects with a cataract grade of 1 to 3+ and are scheduled to undergo cataract surgery 4. Subjects ≥ 18 years of age 5. Clear intraocular media, other than cataract
Exclusion criteria
1. Polar cataracts 2. Zonular instability 3. History of dry eye treatments/devices and or dry eye medications other than artificial tears. 4. Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit 5. Subjects that are pregnant, lactating or planning to become pregnant during the course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Lens Removal Time | 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. |
| Amount of Irrigation Solution Fluid Volume Used During the Surgical Procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCDVA at 1 Week | 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. |
| BCDVA at 1 Month | 1 month postoperative | Assessment of BCDVA at the 1 Month postoperative visit |
| Change in Corneal Thickness | 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. |
| Corneal Edema | Pre-operative | Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe |
| Corneal Edema 1 Day Postoperative | 1 Day Postoperative | Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe |
| Corneal Edema 1-Week Postoperative | 1-Week Postoperative | Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe |
| Corneal Edema 1 Month Postoperative | 1 Month Postoperative | Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe |
| Corneal Cells | Pre-operative | 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. |
| Total Surgical Procedure Time | 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. |
| Posterior Capsule Opacification | Pre-operative | Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe. |
| Posterior Capsule Opacificaiton | 1-Week Postoperative | Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe. |
| Corneal Staining Erosion | Pre-operative | Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe |
| Other Slit-Lamp Findings | Preoperative | Assessment of other slit-lamp exam findings not listed on data collection form. |
| Macula | Pre-operative | Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. |
| Disc Appearance | Pre-operative | Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. |
| Vessels | Pre-operative | Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. |
| Periphery | Pre-operative | Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. |
| Anterior Chamber Flare | 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. |
| UCVA at 1-Day | Postoperative 1 Day | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| 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. | 56 |
| Total | 100 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 24 Participants | 47 Participants | 71 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 9 Participants | 29 Participants |
| Age, Continuous | 66.3 years STANDARD_DEVIATION 6.6 | 70.2 years STANDARD_DEVIATION 6.2 | 68.5 years STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 54 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 36 Participants | 53 Participants | 89 Participants |
| Region of Enrollment United States | 44 participants | 56 participants | 100 participants |
| Sex: Female, Male Female | 26 Participants | 30 Participants | 56 Participants |
| Sex: Female, Male Male | 18 Participants | 26 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 56 |
| other Total, other adverse events | 10 / 44 | 13 / 56 |
| serious Total, serious adverse events | 0 / 44 | 1 / 56 |
Outcome results
Primary
Amount of Irrigation Solution Fluid Volume Used During the Surgical Procedure
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.
Time frame: Assessed during the surgical procedure, approximately 8 - 10 minutes.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1 | Amount of Irrigation Solution Fluid Volume Used During the Surgical Procedure | 40.7 Milliliters |
| Cohort 2 | Amount of Irrigation Solution Fluid Volume Used During the Surgical Procedure | 35.3 Milliliters |
Primary
Total Lens Removal Time
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.
Time frame: Assessed during the surgical procedure, measured in seconds.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1 | Total Lens Removal Time | 76.0 seconds |
| Cohort 2 | Total Lens Removal Time | 80.1 seconds |
Secondary
Anterior Chamber Flare
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.
Time frame: 1-Month Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Anterior Chamber Flare | Postoperative 1 Month 0 Anterior Chamber Flare | 43 Participants |
| Cohort 1 | Anterior Chamber Flare | Postoperative 1 Month >0 Anterior Chamber Flare | 0 Participants |
| Cohort 2 | Anterior Chamber Flare | Postoperative 1 Month 0 Anterior Chamber Flare | 55 Participants |
| Cohort 2 | Anterior Chamber Flare | Postoperative 1 Month >0 Anterior Chamber Flare | 0 Participants |
Secondary
Anterior Chamber Flare
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.
Time frame: 1-Week Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Anterior Chamber Flare | Postoperative 1 Week 0 Anterior Chamber Flare | 44 Participants |
| Cohort 1 | Anterior Chamber Flare | Postoperative 1 Week >0 Anterior Chamber Flare | 0 Participants |
| Cohort 2 | Anterior Chamber Flare | Postoperative 1 Week 0 Anterior Chamber Flare | 56 Participants |
| Cohort 2 | Anterior Chamber Flare | Postoperative 1 Week >0 Anterior Chamber Flare | 0 Participants |
Secondary
Anterior Chamber Flare
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.
Time frame: 1-Day Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Anterior Chamber Flare | Postoperative 1 Day 0 Anterior Chamber Flare | 41 Participants |
| Cohort 1 | Anterior Chamber Flare | Postoperative 1 Day Faint Anterior Chamber Flare | 3 Participants |
| Cohort 2 | Anterior Chamber Flare | Postoperative 1 Day 0 Anterior Chamber Flare | 51 Participants |
| Cohort 2 | Anterior Chamber Flare | Postoperative 1 Day Faint Anterior Chamber Flare | 5 Participants |
Secondary
Anterior Chamber Flare
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.
Time frame: Pre-operative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Anterior Chamber Flare | Preoperative 0 Anterior Chamber Flare | 44 Participants |
| Cohort 1 | Anterior Chamber Flare | Preoperative >0 Anterior Chamber Flare | 0 Participants |
| Cohort 2 | Anterior Chamber Flare | Preoperative 0 Anterior Chamber Flare | 56 Participants |
| Cohort 2 | Anterior Chamber Flare | Preoperative >0 Anterior Chamber Flare | 0 Participants |
Secondary
BCDVA at 1 Month
Assessment of BCDVA at the 1 Month postoperative visit
Time frame: 1 month postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | BCDVA at 1 Month | Postoperative 1-Month BCDVA 20/30 | 1 Participants |
| Cohort 1 | BCDVA at 1 Month | Postoperative 1-Month BCDVA 20/15 | 2 Participants |
| Cohort 1 | BCDVA at 1 Month | Postoperative 1-Month BCDVA 20/20 | 31 Participants |
| Cohort 1 | BCDVA at 1 Month | Postoperative 1-Month BCDVA 20/25 | 8 Participants |
| Cohort 1 | BCDVA at 1 Month | Postoperative 1-Month BCDVA 20/40 | 1 Participants |
| Cohort 2 | BCDVA at 1 Month | Postoperative 1-Month BCDVA 20/40 | 1 Participants |
| Cohort 2 | BCDVA at 1 Month | Postoperative 1-Month BCDVA 20/20 | 35 Participants |
| Cohort 2 | BCDVA at 1 Month | Postoperative 1-Month BCDVA 20/25 | 10 Participants |
| Cohort 2 | BCDVA at 1 Month | Postoperative 1-Month BCDVA 20/15 | 3 Participants |
| Cohort 2 | BCDVA at 1 Month | Postoperative 1-Month BCDVA 20/30 | 6 Participants |
Secondary
BCDVA at 1 Week
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.
Time frame: 1- week postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | BCDVA at 1 Week | Postoperative 1-Week BCDVA 20/30 | 2 Participants |
| Cohort 1 | BCDVA at 1 Week | Postoperative 1-Week BCDVA 20/15 | 1 Participants |
| Cohort 1 | BCDVA at 1 Week | Postoperative 1-Week BCDVA 20/50 | 0 Participants |
| Cohort 1 | BCDVA at 1 Week | Postoperative 1-Week BCDVA 20/25 | 10 Participants |
| Cohort 1 | BCDVA at 1 Week | Postoperative 1-Week BCDVA 20/150 | 0 Participants |
| Cohort 1 | BCDVA at 1 Week | Postoperative 1-Week BCDVA 20/20 | 30 Participants |
| Cohort 2 | BCDVA at 1 Week | Postoperative 1-Week BCDVA 20/150 | 1 Participants |
| Cohort 2 | BCDVA at 1 Week | Postoperative 1-Week BCDVA 20/20 | 36 Participants |
| Cohort 2 | BCDVA at 1 Week | Postoperative 1-Week BCDVA 20/25 | 11 Participants |
| Cohort 2 | BCDVA at 1 Week | Postoperative 1-Week BCDVA 20/30 | 6 Participants |
| Cohort 2 | BCDVA at 1 Week | Postoperative 1-Week BCDVA 20/50 | 1 Participants |
| Cohort 2 | BCDVA at 1 Week | Postoperative 1-Week BCDVA 20/15 | 0 Participants |
Secondary
Change in Corneal Thickness
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.
Time frame: Measured at Baseline, 1 Day, 1 Week and 1 Month postoperative.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change in Corneal Thickness | Preoperative Corneal Thickness | 542.9 μm | Standard Deviation 30.8 |
| Cohort 1 | Change in Corneal Thickness | 1 Day Corneal Thickness | 620.5 μm | Standard Deviation 108.2 |
| Cohort 1 | Change in Corneal Thickness | 1 Week Corneal Thickness | 559.4 μm | Standard Deviation 43.6 |
| Cohort 1 | Change in Corneal Thickness | 1 Month Corneal Thickness | 549.1 μm | Standard Deviation 40.2 |
| Cohort 2 | Change in Corneal Thickness | 1 Month Corneal Thickness | 543.1 μm | Standard Deviation 32.1 |
| Cohort 2 | Change in Corneal Thickness | Preoperative Corneal Thickness | 540.2 μm | Standard Deviation 29.7 |
| Cohort 2 | Change in Corneal Thickness | 1 Week Corneal Thickness | 563.0 μm | Standard Deviation 43.5 |
| Cohort 2 | Change in Corneal Thickness | 1 Day Corneal Thickness | 641.1 μm | Standard Deviation 210.4 |
Secondary
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.
Time frame: Pre-operative
Population: Preoperative \>1 Corneal Cells
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Corneal Cells | 0 Corneal Cells | 44 Participants |
| Cohort 1 | Corneal Cells | > 0 Corneal Cells | 0 Participants |
| Cohort 2 | Corneal Cells | 0 Corneal Cells | 56 Participants |
| Cohort 2 | Corneal Cells | > 0 Corneal Cells | 0 Participants |
Secondary
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
Time frame: 1-Week Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Corneal Cells | Postoperative 1-Week >1 Corneal Cell | 38 Participants |
| Cohort 1 | Corneal Cells | Postoperative 1-Week 1-5 Corneal Cells | 3 Participants |
| Cohort 1 | Corneal Cells | Postoperative 1-Week 6-15 Corneal Cells | 3 Participants |
| Cohort 2 | Corneal Cells | Postoperative 1-Week >1 Corneal Cell | 47 Participants |
| Cohort 2 | Corneal Cells | Postoperative 1-Week 1-5 Corneal Cells | 7 Participants |
| Cohort 2 | Corneal Cells | Postoperative 1-Week 6-15 Corneal Cells | 2 Participants |
Secondary
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
Time frame: 1-Month Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Corneal Cells | Postoperative 1-Month 0 Corneal Cells | 43 Participants |
| Cohort 1 | Corneal Cells | Postoperative 1-Month >1 Corneal Cells | 0 Participants |
| Cohort 2 | Corneal Cells | Postoperative 1-Month 0 Corneal Cells | 55 Participants |
| Cohort 2 | Corneal Cells | Postoperative 1-Month >1 Corneal Cells | 0 Participants |
Secondary
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
Time frame: 1 Day Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Corneal Cells | Postoperative 1 Day 6-15 Corneal Cells | 17 Participants |
| Cohort 1 | Corneal Cells | Postoperative 1 Day 26-50 Corneal Cells | 1 Participants |
| Cohort 1 | Corneal Cells | Postoperative 1 Day 16-25 Corneal Cells | 1 Participants |
| Cohort 1 | Corneal Cells | Postoperative 1 Day >1 Corneal Cells | 10 Participants |
| Cohort 1 | Corneal Cells | Postoperative 1 Day 1-5 Corneal Cells | 15 Participants |
| Cohort 2 | Corneal Cells | Postoperative 1 Day >1 Corneal Cells | 15 Participants |
| Cohort 2 | Corneal Cells | Postoperative 1 Day 1-5 Corneal Cells | 9 Participants |
| Cohort 2 | Corneal Cells | Postoperative 1 Day 6-15 Corneal Cells | 28 Participants |
| Cohort 2 | Corneal Cells | Postoperative 1 Day 16-25 Corneal Cells | 4 Participants |
| Cohort 2 | Corneal Cells | Postoperative 1 Day 26-50 Corneal Cells | 0 Participants |
Secondary
Corneal Edema
Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe
Time frame: Pre-operative
Population: Preoperative Corneal Edema
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Corneal Edema | 0 Corneal Edema | 44 Participants |
| Cohort 1 | Corneal Edema | Corneal Edema >0 | 0 Participants |
| Cohort 2 | Corneal Edema | 0 Corneal Edema | 56 Participants |
| Cohort 2 | Corneal Edema | Corneal Edema >0 | 0 Participants |
Secondary
Corneal Edema 1 Day Postoperative
Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe
Time frame: 1 Day Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Corneal Edema 1 Day Postoperative | Postoperative 1-Day No Corneal Edema | 27 Participants |
| Cohort 1 | Corneal Edema 1 Day Postoperative | Postoperative 1-Day Mild Corneal Edema | 8 Participants |
| Cohort 1 | Corneal Edema 1 Day Postoperative | Postoperative 1-Day Moderate Corneal Edema | 8 Participants |
| Cohort 1 | Corneal Edema 1 Day Postoperative | Postoperative 1-Day Severe Corneal Edema | 1 Participants |
| Cohort 2 | Corneal Edema 1 Day Postoperative | Postoperative 1-Day Severe Corneal Edema | 3 Participants |
| Cohort 2 | Corneal Edema 1 Day Postoperative | Postoperative 1-Day No Corneal Edema | 18 Participants |
| Cohort 2 | Corneal Edema 1 Day Postoperative | Postoperative 1-Day Moderate Corneal Edema | 16 Participants |
| Cohort 2 | Corneal Edema 1 Day Postoperative | Postoperative 1-Day Mild Corneal Edema | 19 Participants |
Secondary
Corneal Edema 1 Month Postoperative
Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe
Time frame: 1 Month Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Corneal Edema 1 Month Postoperative | No Corneal Edema | 43 Participants |
| Cohort 1 | Corneal Edema 1 Month Postoperative | > 0 Corneal Edema | 0 Participants |
| Cohort 2 | Corneal Edema 1 Month Postoperative | No Corneal Edema | 55 Participants |
| Cohort 2 | Corneal Edema 1 Month Postoperative | > 0 Corneal Edema | 0 Participants |
Secondary
Corneal Edema 1-Week Postoperative
Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe
Time frame: 1-Week Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Corneal Edema 1-Week Postoperative | Postoperative 1-Week No Corneal Edema | 43 Participants |
| Cohort 1 | Corneal Edema 1-Week Postoperative | Postoperative 1-Week Mild Corneal Edema | 1 Participants |
| Cohort 1 | Corneal Edema 1-Week Postoperative | Postoperative 1-Week Severe Corneal Edema | 0 Participants |
| Cohort 2 | Corneal Edema 1-Week Postoperative | Postoperative 1-Week No Corneal Edema | 53 Participants |
| Cohort 2 | Corneal Edema 1-Week Postoperative | Postoperative 1-Week Mild Corneal Edema | 2 Participants |
| Cohort 2 | Corneal Edema 1-Week Postoperative | Postoperative 1-Week Severe Corneal Edema | 1 Participants |
Secondary
Corneal Staining Erosion
Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe
Time frame: 1-Day Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Corneal Staining Erosion | Postoperative 1 Day 0 Cornea Staining Erosion | 43 Participants |
| Cohort 1 | Corneal Staining Erosion | Postoperative 1 Day Mild Cornea Staining Erosion | 1 Participants |
| Cohort 2 | Corneal Staining Erosion | Postoperative 1 Day 0 Cornea Staining Erosion | 54 Participants |
| Cohort 2 | Corneal Staining Erosion | Postoperative 1 Day Mild Cornea Staining Erosion | 2 Participants |
Secondary
Corneal Staining Erosion
Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe
Time frame: 1-Week Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Corneal Staining Erosion | Postoperative 1 Week 0 Cornea Staining Erosion | 44 Participants |
| Cohort 1 | Corneal Staining Erosion | Postoperative 1 Week >0 Cornea Staining | 0 Participants |
| Cohort 2 | Corneal Staining Erosion | Postoperative 1 Week 0 Cornea Staining Erosion | 56 Participants |
| Cohort 2 | Corneal Staining Erosion | Postoperative 1 Week >0 Cornea Staining | 0 Participants |
Secondary
Corneal Staining Erosion
Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe
Time frame: 1-Month Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Corneal Staining Erosion | Postoperative 1 Month 0 Cornea Staining | 43 Participants |
| Cohort 1 | Corneal Staining Erosion | Postoperative 1 Month >0 Cornea Staining | 0 Participants |
| Cohort 2 | Corneal Staining Erosion | Postoperative 1 Month 0 Cornea Staining | 55 Participants |
| Cohort 2 | Corneal Staining Erosion | Postoperative 1 Month >0 Cornea Staining | 0 Participants |
Secondary
Corneal Staining Erosion
Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe
Time frame: Pre-operative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Corneal Staining Erosion | Preoperative 0 Cornea Staining Erosion | 44 Participants |
| Cohort 1 | Corneal Staining Erosion | Preoperative >0 Cornea Staining Erosion | 0 Participants |
| Cohort 2 | Corneal Staining Erosion | Preoperative 0 Cornea Staining Erosion | 56 Participants |
| Cohort 2 | Corneal Staining Erosion | Preoperative >0 Cornea Staining Erosion | 0 Participants |
Secondary
Disc Appearance
Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Time frame: Pre-operative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Disc Appearance | Preoperative Disc Assessment Normal | 38 Participants |
| Cohort 1 | Disc Appearance | Preoperative Disc Assessment Abnormal | 6 Participants |
| Cohort 2 | Disc Appearance | Preoperative Disc Assessment Normal | 48 Participants |
| Cohort 2 | Disc Appearance | Preoperative Disc Assessment Abnormal | 8 Participants |
Secondary
Disc Appearance
Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Time frame: 1-Month Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Disc Appearance | Postoperative 1-Month Disc Assessment Normal | 33 Participants |
| Cohort 1 | Disc Appearance | Postoperative 1-Month Disc Assessment Abnormal | 10 Participants |
| Cohort 2 | Disc Appearance | Postoperative 1-Month Disc Assessment Normal | 53 Participants |
| Cohort 2 | Disc Appearance | Postoperative 1-Month Disc Assessment Abnormal | 2 Participants |
Secondary
Macula
Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Time frame: Pre-operative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Macula | Preoperative Macula Assessment Normal | 38 Participants |
| Cohort 1 | Macula | Preoperative Macula Assessment Abnormal | 6 Participants |
| Cohort 2 | Macula | Preoperative Macula Assessment Normal | 48 Participants |
| Cohort 2 | Macula | Preoperative Macula Assessment Abnormal | 8 Participants |
Secondary
Macula
Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Time frame: 1-Month Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Macula | Postoperative 1-Month Macula Assessment Normal | 36 Participants |
| Cohort 1 | Macula | Postoperative 1-Month Macula Assessment Abormal | 7 Participants |
| Cohort 2 | Macula | Postoperative 1-Month Macula Assessment Normal | 51 Participants |
| Cohort 2 | Macula | Postoperative 1-Month Macula Assessment Abormal | 4 Participants |
Secondary
Other Slit-Lamp Findings
Assessment of other slit-lamp exam findings not listed on data collection form.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Other Slit-Lamp Findings | Postoperative 1-Month Other Slit-Lamp Findings | 6 Participants |
| Cohort 1 | Other Slit-Lamp Findings | Postoperative 1-Month No Other Slit-Lamp Findings | 37 Participants |
| Cohort 2 | Other Slit-Lamp Findings | Postoperative 1-Month No Other Slit-Lamp Findings | 50 Participants |
| Cohort 2 | Other Slit-Lamp Findings | Postoperative 1-Month Other Slit-Lamp Findings | 5 Participants |
Secondary
Other Slit-Lamp Findings
Assessment of other slit-lamp exam findings not listed on data collection form.
Time frame: 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Other Slit-Lamp Findings | Preoperative Other Slit-Lamp Findings | 5 Participants |
| Cohort 1 | Other Slit-Lamp Findings | Preoperative No Other Slit-Lamp Findings | 39 Participants |
| Cohort 2 | Other Slit-Lamp Findings | Preoperative Other Slit-Lamp Findings | 2 Participants |
| Cohort 2 | Other Slit-Lamp Findings | Preoperative No Other Slit-Lamp Findings | 54 Participants |
Secondary
Other Slit-Lamp Findings
Assessment of other slit-lamp exam findings not listed on data collection form.
Time frame: 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Other Slit-Lamp Findings | Postoperative 1-Day other slit-lamp findings | 3 Participants |
| Cohort 1 | Other Slit-Lamp Findings | Postoperative 1-Day no other slit-lamp findings | 41 Participants |
| Cohort 2 | Other Slit-Lamp Findings | Postoperative 1-Day other slit-lamp findings | 1 Participants |
| Cohort 2 | Other Slit-Lamp Findings | Postoperative 1-Day no other slit-lamp findings | 55 Participants |
Secondary
Other Slit-Lamp Findings
Assessment of other slit-lamp exam findings not listed on data collection form.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Other Slit-Lamp Findings | Postoperative 1-Week Other Slit-Lamp Findings | 3 Participants |
| Cohort 1 | Other Slit-Lamp Findings | Postoperative 1-Week No Other Slit-Lamp Findings | 41 Participants |
| Cohort 2 | Other Slit-Lamp Findings | Postoperative 1-Week Other Slit-Lamp Findings | 3 Participants |
| Cohort 2 | Other Slit-Lamp Findings | Postoperative 1-Week No Other Slit-Lamp Findings | 53 Participants |
Secondary
Periphery
Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Time frame: Pre-operative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Periphery | Preoperative Periphery Assessment Normal | 43 Participants |
| Cohort 1 | Periphery | Preoperative Periphery Assessment Abnormal | 1 Participants |
| Cohort 2 | Periphery | Preoperative Periphery Assessment Normal | 49 Participants |
| Cohort 2 | Periphery | Preoperative Periphery Assessment Abnormal | 7 Participants |
Secondary
Periphery
Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Time frame: 1-Month Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Periphery | Postoperative 1-Month Periphery Assessment Normal | 42 Participants |
| Cohort 1 | Periphery | Postoperative 1-Month Periphery Assessment Abnormal | 1 Participants |
| Cohort 2 | Periphery | Postoperative 1-Month Periphery Assessment Normal | 48 Participants |
| Cohort 2 | Periphery | Postoperative 1-Month Periphery Assessment Abnormal | 7 Participants |
Secondary
Posterior Capsule Opacificaiton
Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.
Time frame: 1-Week Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Posterior Capsule Opacificaiton | Postoperative 1 Week 0 Posterior Capsule Opacification | 43 Participants |
| Cohort 1 | Posterior Capsule Opacificaiton | Postoperative 1 Week Minimal Posterior Capsule Opacification | 1 Participants |
| Cohort 2 | Posterior Capsule Opacificaiton | Postoperative 1 Week 0 Posterior Capsule Opacification | 56 Participants |
| Cohort 2 | Posterior Capsule Opacificaiton | Postoperative 1 Week Minimal Posterior Capsule Opacification | 0 Participants |
Secondary
Posterior Capsule Opacification
Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.
Time frame: 1-Day Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Posterior Capsule Opacification | Postoperative 1 Day 0 Posterior Capsule Opacification | 44 Participants |
| Cohort 1 | Posterior Capsule Opacification | Postoperative 1 Day >0 Posterior Capsule Opacification | 0 Participants |
| Cohort 2 | Posterior Capsule Opacification | Postoperative 1 Day 0 Posterior Capsule Opacification | 56 Participants |
| Cohort 2 | Posterior Capsule Opacification | Postoperative 1 Day >0 Posterior Capsule Opacification | 0 Participants |
Secondary
Posterior Capsule Opacification
Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.
Time frame: 1-Month Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Posterior Capsule Opacification | Postoperative 1 Month 0 Posterior Capsule Opacification | 39 Participants |
| Cohort 1 | Posterior Capsule Opacification | Postoperative 1 Month Minimal Posterior Capsule Opacification | 3 Participants |
| Cohort 1 | Posterior Capsule Opacification | Postoperative 1 Month Mild Posterior Capsule Opacification | 1 Participants |
| Cohort 1 | Posterior Capsule Opacification | Postoperative 1 Month Moderate Posterior Capsule Opacification | 0 Participants |
| Cohort 2 | Posterior Capsule Opacification | Postoperative 1 Month Moderate Posterior Capsule Opacification | 1 Participants |
| Cohort 2 | Posterior Capsule Opacification | Postoperative 1 Month 0 Posterior Capsule Opacification | 47 Participants |
| Cohort 2 | Posterior Capsule Opacification | Postoperative 1 Month Mild Posterior Capsule Opacification | 1 Participants |
| Cohort 2 | Posterior Capsule Opacification | Postoperative 1 Month Minimal Posterior Capsule Opacification | 6 Participants |
Secondary
Posterior Capsule Opacification
Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe.
Time frame: Pre-operative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Posterior Capsule Opacification | Preoperative 0 Posterior Capsule Opacification | 44 Participants |
| Cohort 1 | Posterior Capsule Opacification | Preoperative >0 Posterior Capsule Opacification | 0 Participants |
| Cohort 2 | Posterior Capsule Opacification | Preoperative 0 Posterior Capsule Opacification | 56 Participants |
| Cohort 2 | Posterior Capsule Opacification | Preoperative >0 Posterior Capsule Opacification | 0 Participants |
Secondary
Total Surgical Procedure Time
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.
Time frame: Assessed during the surgical procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Total Surgical Procedure Time | 486.3 seconds | Standard Deviation 151.7 |
| Cohort 2 | Total Surgical Procedure Time | 440.0 seconds | Standard Deviation 143.1 |
Secondary
UCVA at 1-Day
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.
Time frame: Postoperative 1 Day
Population: Some outcome measures are based on participants while other outcome measures are based on means on a unit scale
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | UCVA at 1-Day | UCVA 20/50 @ 1-Day | 3 Participants |
| Cohort 1 | UCVA at 1-Day | UCVA 20/20 @ 1-Day | 14 Participants |
| Cohort 1 | UCVA at 1-Day | UCVA 20/60 @ 1-Day | 0 Participants |
| Cohort 1 | UCVA at 1-Day | UCVA 20/320 @ 1-Day | 0 Participants |
| Cohort 1 | UCVA at 1-Day | UCVA 20/70 @ 1-Day | 0 Participants |
| Cohort 1 | UCVA at 1-Day | UCVA 20/25 @ 1-Day | 13 Participants |
| Cohort 1 | UCVA at 1-Day | UCVA 20/80 @ 1-Day | 1 Participants |
| Cohort 1 | UCVA at 1-Day | UCVA 20/100 @ 1-Day | 0 Participants |
| Cohort 1 | UCVA at 1-Day | UCVA 20/30 @ 1-Day | 7 Participants |
| Cohort 1 | UCVA at 1-Day | UCVA 20/150 @ 1-Day | 2 Participants |
| Cohort 1 | UCVA at 1-Day | UCVA 20/40 @ 1-Day | 4 Participants |
| Cohort 1 | UCVA at 1-Day | UCVA 20/200 @ 1-Day | 0 Participants |
| Cohort 1 | UCVA at 1-Day | Finger Count @ 1-Day | 0 Participants |
| Cohort 2 | UCVA at 1-Day | Finger Count @ 1-Day | 1 Participants |
| Cohort 2 | UCVA at 1-Day | UCVA 20/80 @ 1-Day | 0 Participants |
| Cohort 2 | UCVA at 1-Day | UCVA 20/200 @ 1-Day | 3 Participants |
| Cohort 2 | UCVA at 1-Day | UCVA 20/320 @ 1-Day | 1 Participants |
| Cohort 2 | UCVA at 1-Day | UCVA 20/20 @ 1-Day | 15 Participants |
| Cohort 2 | UCVA at 1-Day | UCVA 20/30 @ 1-Day | 8 Participants |
| Cohort 2 | UCVA at 1-Day | UCVA 20/40 @ 1-Day | 8 Participants |
| Cohort 2 | UCVA at 1-Day | UCVA 20/50 @ 1-Day | 2 Participants |
| Cohort 2 | UCVA at 1-Day | UCVA 20/60 @ 1-Day | 2 Participants |
| Cohort 2 | UCVA at 1-Day | UCVA 20/70 @ 1-Day | 5 Participants |
| Cohort 2 | UCVA at 1-Day | UCVA 20/100 @ 1-Day | 1 Participants |
| Cohort 2 | UCVA at 1-Day | UCVA 20/150 @ 1-Day | 0 Participants |
| Cohort 2 | UCVA at 1-Day | UCVA 20/25 @ 1-Day | 10 Participants |
Secondary
Vessels
Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Time frame: Pre-operative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Vessels | Preoperative Vessel Assessment Normal | 43 Participants |
| Cohort 1 | Vessels | Preoperative Vessel Assessment Abnormal | 1 Participants |
| Cohort 2 | Vessels | Preoperative Vessel Assessment Normal | 54 Participants |
| Cohort 2 | Vessels | Preoperative Vessel Assessment Abnormal | 2 Participants |
Secondary
Vessels
Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.
Time frame: 1-Month Postoperative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Vessels | Postoperative 1-Month Vessel Assessment Normal | 43 Participants |
| Cohort 1 | Vessels | Postoperative 1-Month Vessel Assessment Abnormal | 0 Participants |
| Cohort 2 | Vessels | Postoperative 1-Month Vessel Assessment Normal | 54 Participants |
| Cohort 2 | Vessels | Postoperative 1-Month Vessel Assessment Abnormal | 1 Participants |