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Completed

NCT Number: NCT04747834

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Young H. Choi Eye Surgery Center, Vestavia Hills, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Total Lens Removal Time

    Time frame: 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.

  2. Amount of Irrigation Solution Fluid Volume Used During the Surgical Procedure

    Time frame: 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 outcomes

  1. 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.

  2. UCVA at 1-Day

    Time frame: 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.

  3. BCDVA at 1 Week

    Time frame: 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.

  4. BCDVA at 1 Month

    Time frame: 1 month postoperative

    Assessment of BCDVA at the 1 Month postoperative visit

  5. Change in Corneal Thickness

    Time frame: 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".

  6. Corneal Edema

    Time frame: Pre-operative

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

  7. Corneal Edema 1 Day Postoperative

    Time frame: 1 Day Postoperative

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

  8. Corneal Edema 1-Week Postoperative

    Time frame: 1-Week Postoperative

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

  9. Corneal Edema 1 Month Postoperative

    Time frame: 1 Month Postoperative

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

  10. Corneal Cells

    Time frame: 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.

  11. Corneal Cells

    Time frame: 1 Day Postoperative

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

  12. Corneal Cells

    Time frame: 1-Week Postoperative

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

  13. Corneal Cells

    Time frame: 1-Month Postoperative

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

  14. Anterior Chamber Flare

    Time frame: 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.

  15. Anterior Chamber Flare

    Time frame: 1-Day Postoperative

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

  16. Anterior Chamber Flare

    Time frame: 1-Week Postoperative

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

  17. Anterior Chamber Flare

    Time frame: 1-Month Postoperative

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

  18. Posterior Capsule Opacification

    Time frame: Pre-operative

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

  19. Posterior Capsule Opacification

    Time frame: 1-Day Postoperative

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

  20. Posterior Capsule Opacificaiton

    Time frame: 1-Week Postoperative

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

  21. Posterior Capsule Opacification

    Time frame: 1-Month Postoperative

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

  22. Corneal Staining Erosion

    Time frame: Pre-operative

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

  23. Corneal Staining Erosion

    Time frame: 1-Day Postoperative

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

  24. Corneal Staining Erosion

    Time frame: 1-Week Postoperative

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

  25. Corneal Staining Erosion

    Time frame: 1-Month Postoperative

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

  26. Other Slit-Lamp Findings

    Time frame: Preoperative

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

  27. Other Slit-Lamp Findings

    Time frame: 1-Day Postoperative

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

  28. Other Slit-Lamp Findings

    Time frame: 1-Week Postoperative

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

  29. Other Slit-Lamp Findings

    Time frame: 1-Month Postoperative

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

  30. Macula

    Time frame: Pre-operative

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

  31. Macula

    Time frame: 1-Month Postoperative

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

  32. Disc Appearance

    Time frame: Pre-operative

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

  33. Disc Appearance

    Time frame: 1-Month Postoperative

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

  34. Vessels

    Time frame: Pre-operative

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

  35. Vessels

    Time frame: 1-Month Postoperative

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

  36. Periphery

    Time frame: Pre-operative

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

  37. Periphery

    Time frame: 1-Month Postoperative

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

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2021
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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