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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Multicenter Study to Assess The Clinical Outcomes of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery

Conditions
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Cataract

Intervention / Treatment
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* Device: MICOR-304


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits Willing and able to understand and complete the informed consent document Subjects with a cataract grade of 1 to 3+ and are scheduled to undergo cataract surgery Subjects ≥ 18 years of age Clear intraocular media, other than cataract Exclusion Criteria: Polar cataracts Zonular instability History of dry eye treatments/devices and or dry eye medications other than artificial tears. Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit Subjects that are pregnant, lactating or planning to become pregnant during the course of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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+).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort 1<br>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. | Device: MICOR-304<br>* 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.<br>|
| Active Comparator: Cohort 2<br>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.. | Device: MICOR-304<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. o 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. | Assessed during the surgical procedure. | 
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Visual Acuity | Assessment of Uncorrected Visual Acuity. | Postoperative days 1, 7, and 30. | 
| Change in corneal thickness | Assessment in change in corneal thickness from baseline through end of study. | Baseline through 30 days postoperative. | 
| Rate of occurrence of intraoperative and postoperative adverse events | Assessment of intraoperative and postoperative adverse events. | From study enrollment through study completion at 1 month postoperative. | 
| Corneal Edema | Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe assessed via slit-lamp. | Pre-operative, 1-day, 1-week and 1-month postoperative study completion. | 
| 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 assessed via slit-lamp. | Pre-operative, 1-day, 1-week and 1-month postoperative study completion. | 
| 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 assessed via slit-lamp. | Pre-operative, 1-day, 1-week and 1-month postoperative study completion. | 
| Posterior Capsule Opacification | Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe assessed via slit-lamp. | Pre-operative, 1-day, 1-week and 1-month postoperative study completion. | 
| Corneal Staining Erosion | Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe assessed via slit-lamp. | Pre-operative, 1-day, 1-week and 1-month postoperative study completion. | 
| Disc Appearance | Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Pre-operative and 1-month postoperative study completion. | 
| Macula | Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Pre-operative and 1-month postoperative study completion. | 
| Vessels | Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Pre-operative and 1-month postoperative study completion. | 
| Periphery | Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination. | Pre-operative and 1-month postoperative study completion. | 
| 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. |