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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator | 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. |
|
| Cohort 2 | Active Comparator | 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.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MICOR-304 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Lens Removal Time | Total lens removal time is defined in two phases:
The total lens removal time as defined above is recorded in minutes and seconds. | Assessed during the surgical procedure, measured in seconds. |
| 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. | Assessed during the surgical procedure, approximately 8 - 10 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed during the surgical procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farrell C. Tyson, M.D. | Argus Research at Cape Coral Eye Center | Principal Investigator |
| Young H. Choi, M.D. | Young H Choi Eye Surgery Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Young H. Choi Eye Surgery Center | Vestavia Hills | Alabama | 35243 | United States | ||
| Argus Research at Cape Coral Eye Center |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Lens Removal Time | Total lens removal time is defined in two phases:
The total lens removal time as defined above is recorded in minutes and seconds. | Posted | Mean | 95% Confidence Interval | seconds | Assessed during the surgical procedure, measured in seconds. |
|
1-Month
Nothing more applicable
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Immune system disorders | Non-systematic Assessment | At 1 month postoperative (8/23/21), the subject was hospitalized with pneumonia for 3 days. The event was serious, unrelated to the study device, and the subject was released from the hospital and fully recovered. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Study Eye - Raised IOP Requiring Treatment | Eye disorders | Non-systematic Assessment | Seven subjects had raised Intraocular Pressure (IOP) requiring treatment. All subjects recovered from the AE with no sequelae. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gretchen Neumann | Regulatory Pathways Group, Inc. | 19494667124 | gneumann@regulatorypathways.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2021 | Mar 1, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 17, 2021 | Mar 1, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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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+).
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|
| 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. | Postoperative 1 Day |
| 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. | 1- week postoperative |
| BCDVA at 1 Month | Assessment of BCDVA at the 1 Month postoperative visit | 1 month postoperative |
| 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". | Measured at Baseline, 1 Day, 1 Week and 1 Month postoperative. |
| Corneal Edema | Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe | Pre-operative |
| Corneal Edema 1 Day Postoperative | Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe | 1 Day Postoperative |
| Corneal Edema 1-Week Postoperative | Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe | 1-Week Postoperative |
| Corneal Edema 1 Month Postoperative | Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe | 1 Month Postoperative |
| 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. | Pre-operative |
| 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 | 1 Day Postoperative |
| 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 | 1-Week Postoperative |
| 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 | 1-Month Postoperative |
| 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. | Pre-operative |
| 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. | 1-Day Postoperative |
| 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. | 1-Week Postoperative |
| 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. | 1-Month Postoperative |
| Posterior Capsule Opacification | Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe. | Pre-operative |
| Posterior Capsule Opacification | Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe. | 1-Day Postoperative |
| Posterior Capsule Opacificaiton | Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe. | 1-Week Postoperative |
| Posterior Capsule Opacification | Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe. | 1-Month Postoperative |
| Corneal Staining Erosion | Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe | Pre-operative |
| Corneal Staining Erosion | Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe | 1-Day Postoperative |
| Corneal Staining Erosion | Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe | 1-Week Postoperative |
| Corneal Staining Erosion | Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe | 1-Month Postoperative |
| Other Slit-Lamp Findings | Assessment of other slit-lamp exam findings not listed on data collection form. | Preoperative |
| Other Slit-Lamp Findings | Assessment of other slit-lamp exam findings not listed on data collection form. | 1-Day Postoperative |
| Other Slit-Lamp Findings | Assessment of other slit-lamp exam findings not listed on data collection form. | 1-Week Postoperative |
| Other Slit-Lamp Findings | Assessment of other slit-lamp exam findings not listed on data collection form. | 1-Month Postoperative |
| Macula | Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Pre-operative |
| Macula | Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | 1-Month Postoperative |
| Disc Appearance | Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Pre-operative |
| Disc Appearance | Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | 1-Month Postoperative |
| Vessels | Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Pre-operative |
| Vessels | Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | 1-Month Postoperative |
| Periphery | Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Pre-operative |
| Periphery | Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | 1-Month Postoperative |
| Cape Coral |
| Florida |
| 33904 |
| United States |
| Chu Vision Institute | Bloomington | Minnesota | 55420 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | Milliliters | Assessed during the surgical procedure, approximately 8 - 10 minutes. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | seconds | Assessed during the surgical procedure. |
|
|
|
| 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. | Some outcome measures are based on participants while other outcome measures are based on means on a unit scale | Posted | Count of Participants | Participants | Postoperative 1 Day |
|
|
|
| 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. | Posted | Count of Participants | Participants | 1- week postoperative |
|
|
|
| Secondary | BCDVA at 1 Month | Assessment of BCDVA at the 1 Month postoperative visit | Posted | Count of Participants | Participants | 1 month postoperative |
|
|
|
| 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". | Posted | Mean | Standard Deviation | μm | Measured at Baseline, 1 Day, 1 Week and 1 Month postoperative. |
|
|
|
| Secondary | Corneal Edema | Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe | Preoperative Corneal Edema | Posted | Count of Participants | Participants | Pre-operative |
|
|
|
| Secondary | Corneal Edema 1 Day Postoperative | Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe | Posted | Count of Participants | Participants | 1 Day Postoperative |
|
|
|
| Secondary | Corneal Edema 1-Week Postoperative | Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate, 3+=Severe | Posted | Count of Participants | Participants | 1-Week Postoperative |
|
|
|
| Secondary | Corneal Edema 1 Month Postoperative | Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe | Posted | Count of Participants | Participants | 1 Month Postoperative |
|
|
|
| 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. | Preoperative >1 Corneal Cells | Posted | Count of Participants | Participants | Pre-operative |
|
|
|
| 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 | Posted | Count of Participants | Participants | 1 Day Postoperative |
|
|
|
| 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 | Posted | Count of Participants | Participants | 1-Week Postoperative |
|
|
|
| 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 | Posted | Count of Participants | Participants | 1-Month Postoperative |
|
|
|
| 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. | Posted | Count of Participants | Participants | Pre-operative |
|
|
|
| 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. | Posted | Count of Participants | Participants | 1-Day Postoperative |
|
|
|
| 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. | Posted | Count of Participants | Participants | 1-Week Postoperative |
|
|
|
| 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. | Posted | Count of Participants | Participants | 1-Month Postoperative |
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| Secondary | Posterior Capsule Opacification | Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe. | Posted | Count of Participants | Participants | Pre-operative |
|
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| Secondary | Posterior Capsule Opacification | Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe. | Posted | Count of Participants | Participants | 1-Day Postoperative |
|
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| Secondary | Posterior Capsule Opacificaiton | Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe. | Posted | Count of Participants | Participants | 1-Week Postoperative |
|
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| Secondary | Posterior Capsule Opacification | Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe. | Posted | Count of Participants | Participants | 1-Month Postoperative |
|
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| Secondary | Corneal Staining Erosion | Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe | Posted | Count of Participants | Participants | Pre-operative |
|
|
|
| Secondary | Corneal Staining Erosion | Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe | Posted | Count of Participants | Participants | 1-Day Postoperative |
|
|
|
| Secondary | Corneal Staining Erosion | Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe | Posted | Count of Participants | Participants | 1-Week Postoperative |
|
|
|
| Secondary | Corneal Staining Erosion | Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe | Posted | Count of Participants | Participants | 1-Month Postoperative |
|
|
|
| Secondary | Other Slit-Lamp Findings | Assessment of other slit-lamp exam findings not listed on data collection form. | 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 | Posted | Count of Participants | Participants | Preoperative |
|
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|
| Secondary | Other Slit-Lamp Findings | Assessment of other slit-lamp exam findings not listed on data collection form. | Other slit-lamp findings mild/moderate cohort: RK incisions, anterior basement membrane dystrophy, LASIK flap, Other slit-lamp findings severe cohort: Pterygium | Posted | Count of Participants | Participants | 1-Day Postoperative |
|
|
|
| Secondary | Other Slit-Lamp Findings | Assessment of other slit-lamp exam findings not listed on data collection form. | 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. | Posted | Count of Participants | Participants | 1-Week Postoperative |
|
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| Secondary | Other Slit-Lamp Findings | Assessment of other slit-lamp exam findings not listed on data collection form. | 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. | Posted | Count of Participants | Participants | 1-Month Postoperative |
|
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| Secondary | Macula | Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Posted | Count of Participants | Participants | Pre-operative |
|
|
|
| Secondary | Macula | Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Posted | Count of Participants | Participants | 1-Month Postoperative |
|
|
|
| Secondary | Disc Appearance | Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Posted | Count of Participants | Participants | Pre-operative |
|
|
|
| Secondary | Disc Appearance | Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Posted | Count of Participants | Participants | 1-Month Postoperative |
|
|
|
| Secondary | Vessels | Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Posted | Count of Participants | Participants | Pre-operative |
|
|
|
| Secondary | Vessels | Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Posted | Count of Participants | Participants | 1-Month Postoperative |
|
|
|
| Secondary | Periphery | Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Posted | Count of Participants | Participants | Pre-operative |
|
|
|
| Secondary | Periphery | Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Posted | Count of Participants | Participants | 1-Month Postoperative |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 10 |
| 44 |
| EG001 | 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. | 0 | 56 | 1 | 56 | 13 | 56 |
|
|
| Study Eye - Posterior Capsule Rupture | Eye disorders | Non-systematic Assessment | During the surgical procedure, the subject had a mild posterior capsule rupture. The investigator continued with the surgery, the event resolved without sequelae and was unrelated to the study device |
|
| Study Eye -Vitreal Prolapse | Eye disorders | Non-systematic Assessment | At 1 Month Postoperative, the subject had a vitreal prolapse. At 5 months postoperative, the vitreous strand was much improved, and the subject recovered with no sequelae |
|
| Study Eye - Cystoid Macular Edema | Eye disorders | Non-systematic Assessment | At 1 month postoperative, the subject presented with cystoid macular edema. The Subject was started on Prolensa OS BID and failed to return after the study completion date. |
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| Study Eye - Increased Inflammation | Eye disorders | Non-systematic Assessment | At 6 weeks postoperative, the subject presented with Increased Inflammation in the study eye. The subject was prescribed an NSAID and the subject recovered with no sequalae. |
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| Study Eye - Ectropion | Eye disorders | Non-systematic Assessment | At 2 Months postoperative the subject presented with an elevated punctal mass with ectropion left lower lid. At 3 months postop the subject underwent ectropion repair with the Oculoplastics surgeon, and the ectropion had resolved. |
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| Study Eye - Dry Eye | Eye disorders | Non-systematic Assessment | Two subjects presented with postoperative dry eye. One of the subjects had their punctal plugs replaced and the AE resolved. The other subject also had the Ectropion AE which may have caused the dry eye, the dry eye AE resolved after surgery. |
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| Study Eye - Corneal Edema | Eye disorders | Non-systematic Assessment | Two subjects had postop corneal edema. One of the subjects was prescribed Durezol and the event resolved. The other subject no action was taken and the event resolved by the next visit. |
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| Study Eye - Crocodile Shagreen | Eye disorders | Non-systematic Assessment | At 1 month postoperative the subject was diagnosed with a mild case of Crocodile Shagreen in both eyes which was unrelated to the study device. The subject was prescribed medication and the event resolved 2 weeks later. |
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| Study Eye - Microcystic Corneal Edema | Eye disorders | Non-systematic Assessment | At 1 month postoperative, the subject presented with cystoid macular edema and was prescribed medication. . The subject cancelled the 2-month appointment and withdrew consent from the study. There is no further follow up for this subject. |
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| Study Eye - IOL Exchange | Eye disorders | Non-systematic Assessment | At 5-weeks postoperative, the subject was unable to tolerate the current IOL in the study eye and had an IOL exchange. At 2 months postoperative the subject had the IOL exchange which was uneventful, and the subject recovered with no sequelae. |
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Not provided
Not provided
| UCVA 20/30 @ 1-Day |
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| UCVA 20/40 @ 1-Day |
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| UCVA 20/50 @ 1-Day |
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| UCVA 20/60 @ 1-Day |
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| UCVA 20/70 @ 1-Day |
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| UCVA 20/80 @ 1-Day |
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| UCVA 20/100 @ 1-Day |
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| UCVA 20/150 @ 1-Day |
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| UCVA 20/200 @ 1-Day |
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| UCVA 20/320 @ 1-Day |
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| Finger Count @ 1-Day |
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| Postoperative 1-Week BCDVA 20/25 |
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| Postoperative 1-Week BCDVA 20/30 |
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| Postoperative 1-Week BCDVA 20/50 |
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| Postoperative 1-Week BCDVA 20/150 |
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| Postoperative 1-Month BCDVA 20/25 |
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| Postoperative 1-Month BCDVA 20/30 |
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| Postoperative 1-Month BCDVA 20/40 |
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| 1 Week Corneal Thickness |
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| 1 Month Corneal Thickness |
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| Postoperative 1-Day Moderate Corneal Edema |
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| Postoperative 1-Day Severe Corneal Edema |
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| Postoperative 1-Week Severe Corneal Edema |
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| Postoperative 1 Day 6-15 Corneal Cells |
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| Postoperative 1 Day 16-25 Corneal Cells |
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| Postoperative 1 Day 26-50 Corneal Cells |
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| Postoperative 1-Week 6-15 Corneal Cells |
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| Postoperative 1 Month Mild Posterior Capsule Opacification |
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| Postoperative 1 Month Moderate Posterior Capsule Opacification |
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