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

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ClinicalTrials.gov Identifier: NCT04747834
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : March 30, 2021
Sponsor:
Collaborator:
Carl Zeiss Meditec Cataract Technology, Inc.
Information provided by (Responsible Party):
Carl Zeiss Meditec, Inc.

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.

Condition or disease Intervention/treatment Phase
Cataract Device: MICOR-304 Not Applicable

Detailed Description:

Up to 100 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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+).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Study to Assess The Clinical Outcomes of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery
Actual Study Start Date : January 26, 2021
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: 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.
Device: 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.

Active Comparator: 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..
Device: 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 Outcome Measures :
  1. Total lens removal time [ Time Frame: Assessed during the surgical procedure. ]

    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.


  2. Amount of irrigation solution fluid volume used during the surgical procedure [ Time Frame: Assessed 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.


Secondary Outcome Measures :
  1. Uncorrected Visual Acuity [ Time Frame: Postoperative days 1, 7, and 30. ]
    Assessment of Uncorrected Visual Acuity.

  2. Change in corneal thickness [ Time Frame: Baseline through 30 days postoperative. ]
    Assessment in change in corneal thickness from baseline through end of study.

  3. Rate of occurrence of intraoperative and postoperative adverse events [ Time Frame: From study enrollment through study completion at 1 month postoperative. ]
    Assessment of intraoperative and postoperative adverse events.

  4. Corneal Edema [ Time Frame: Pre-operative, 1-day, 1-week and 1-month postoperative study completion. ]
    Corneal edema will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3+=Severe assessed via slit-lamp.

  5. Corneal Cells [ Time Frame: Pre-operative, 1-day, 1-week and 1-month postoperative study completion. ]
    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.

  6. Anterior Chamber Flare [ Time Frame: Pre-operative, 1-day, 1-week and 1-month postoperative study completion. ]
    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.

  7. Posterior Capsule Opacification [ Time Frame: Pre-operative, 1-day, 1-week and 1-month postoperative study completion. ]
    Posterior capsule opacification will be assessed as the following: none, minimal, mild, moderate and severe assessed via slit-lamp.

  8. Corneal Staining Erosion [ Time Frame: Pre-operative, 1-day, 1-week and 1-month postoperative study completion. ]
    Corneal staining erosion will be assessed as the following: 0=None, 1+=Mild, 2+=Moderate and 3=Severe assessed via slit-lamp.

  9. Disc Appearance [ Time Frame: Pre-operative and 1-month postoperative study completion. ]
    Disc appearance is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.

  10. Macula [ Time Frame: Pre-operative and 1-month postoperative study completion. ]
    Macula is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.

  11. Vessels [ Time Frame: Pre-operative and 1-month postoperative study completion. ]
    Vessels are assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.

  12. Periphery [ Time Frame: Pre-operative and 1-month postoperative study completion. ]
    Periphery is assessed as normal and abnormal with free text to specify if abnormal, assessed via dilated fundus examination.

  13. Total Surgical Procedure Time [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747834


Contacts
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Contact: Gretchen Neumann, M.S. 9494667124 gretchen@clinregconsulting.com
Contact: Gary Mocnik, M.S. 9494330413 gary@clinregconsulting.com

Locations
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United States, Alabama
Young H. Choi Eye Surgery Center Recruiting
Vestavia Hills, Alabama, United States, 35243
Contact: Young H Choi, M.D.    205-879-2221    ychoi@invisioneyemd.com   
Contact: Patricia Howard, B.S    205-879-8232    thoward@choieyemd.com   
United States, Florida
Argus Research at Cape Coral Eye Center Recruiting
Cape Coral, Florida, United States, 33904
Contact: Farell C Tyson, M.D.    239-542-2020    tysonfc@hotmail.com   
Contact: Nancy Gribosky    239-542-2020    nancy.gribosky@tysoneye.com   
United States, Minnesota
Chu Vision Institute Recruiting
Bloomington, Minnesota, United States, 55420
Contact: Ralph Chu, M.D.    952-835-1235    yrchu@chuvision.com   
Contact: Nic Jabocs, M.S.    952-835-1235    Nic.Jacobs@chuvision.com   
Sponsors and Collaborators
Carl Zeiss Meditec, Inc.
Carl Zeiss Meditec Cataract Technology, Inc.
Investigators
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Principal Investigator: 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
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Responsible Party: Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier: NCT04747834    
Other Study ID Numbers: MICOR-304-101
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases