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Evaluation of the Impact of Corneal Width on Surgically Induced Astigmatism (SIA) and Functional Results After Bimanual 1.4 mm Microincision Cataract Surgery (B-MICS), Coaxial 1.8 mm MICS (C-MICS) and 2.4 mm Small Incision Cataract Surgery (C-SICS). (MICS)

Primary Purpose

Cataract, Corneal Astigmatism, Corneal Incision Contracture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bimanual 1.4 mm microincision cataract surgery (B-MICS) with IOL implantation in a "wound-assisted" technique. In bimanual MICS group a self-sealing 1.4 mm wide incision was created supratemporally
Coaxial 1.8 mm microincision cataract surgery (C-MICS) with IOL implantation with an injector through the 1.8 mm wide incision created temporally.
Coaxial 2.4 mm small incision cataract surgery (C-SICS) with IOL implantation with an injector through the 2.4 mm wide incision located temporally.
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring surgically induced astigmatism, phacoemulsification, bimanual microincision cataract surgery, coaxial microincision cataract surgery, small incision cataract surgery, clear corneal incision

Eligibility Criteria

35 Years - 87 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • lens opacities which were an indication for cataract surgery and absence of exclusion criteria,
  • cataract sclerosis grade from II to IV in Lens Opacities Classification System LOCS III scale (The Lens Opacities Classification System III).

Exclusion Criteria:

  • history of ocular surgery, ocular trauma,
  • congenital ocular malformations, amblyopia,
  • corneal disorders (including corneal opacities and scars),
  • best corrected visual acuity (BCVA) ≥ 0.9,
  • preoperative endothelial cell density <1500 cells/mm2,
  • history of uveitis, diabetic retinopathy,
  • retinal and macular disorders,
  • eventful phacoemulsification
  • presence of other diseases that could affect the postoperative visual outcomes.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    B-MICS 1.4 mm

    C-MICS 1.8 mm

    C-SICS 2.4 mm

    Arm Description

    bimanual 1.4 mm cataract surgery (B-MICS)

    coaxial 1.8 mm cataract surgery (C-MICS)

    coaxial 2.4 mm small incision cataract surgery (C-SICS)

    Outcomes

    Primary Outcome Measures

    the best corrected visual acuity
    examined with digital Snellen chart, measured in decimal scale
    the best uncorrected visual acuity
    examined with digital Snellen chart, measured in decimal scale
    autorefractometry
    measured in diopters (D)
    keratometry
    measured in diopters (D)
    intraocular pressure (IOP)
    measured in millimeters of mercury (mmHg)
    endothelial cell density (ECD)
    measured in endothelial cells/mm2
    central corneal thickness (CCT)
    measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers).
    peripheral temporal corneal thickness
    measured at the main incision site with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
    peripheral nasal corneal thickness
    measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
    anterior chamber depth (ACD)
    measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in mm (milimeters).
    the white-to-white (WTW) distance - the horizontal corneal diameter
    measured with Anterior Segment Optical Coherence Tomography (AS-OCT, unit of measure: mm (milimeters).
    length of the clear corneal incision
    the chord length measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
    anterior chamber angle
    measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in horizontal scan, unit of measure: degrees
    central foveal thickness (CFT)
    measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
    parafoveal retinal thickness
    measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)

    Secondary Outcome Measures

    surgically induced astigmatism SIA
    measured in dioptres (D) - three different methods were used for calculation of surgically induced astigmatism (SIA): vector analysis method, vector decomposition method (C90), Naeser's polar values method (dKP-90)

    Full Information

    First Posted
    August 18, 2022
    Last Updated
    August 19, 2022
    Sponsor
    Medical University of Lodz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05510869
    Brief Title
    Evaluation of the Impact of Corneal Width on Surgically Induced Astigmatism (SIA) and Functional Results After Bimanual 1.4 mm Microincision Cataract Surgery (B-MICS), Coaxial 1.8 mm MICS (C-MICS) and 2.4 mm Small Incision Cataract Surgery (C-SICS).
    Acronym
    MICS
    Official Title
    Comparison of Surgically Induced Astigmatism After Microincision Cataract Surgery (B-MICS 1.4 mm and C-MICS 1.8 mm) and C- SICS 2.4 mm
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    January 1, 2019 (Actual)
    Study Completion Date
    May 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Lodz

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the study is to compare functional results and complications of 3 methods of cataract phacoemulsification: bimanual 1.4 mm cataract surgery (B-MICS), coaxial 1.8 mm cataract surgery (C-MICS) and coaxial 2.4 mm small incision cataract surgery.
    Detailed Description
    Reduction of the width of the corneal incision was one the main changes taking place in cataract surgery in recent years. The common use of foldable intraocular lenses (IOLs) and technological development of phaco machines allowed to reduce clear corneal incision below 3 mm. Term of Microincision Cataract Surgery (MICS) understood as cataract phacoemulsification performed with the incision width below 2 mm was defined by professor Alio in 2003. However, despite various modifications introduced in recent years, phacoemulsification still causes damage of the tissues that results in surgically induced astigmatism. Two MICS techniques have been developed: bimanual microincision cataract surgery (B-MICS) and coaxial microincision cataract surgery (C-MICS). In the bimanual technique cataract phacoemulsification can be performed through the main incision 1.4 mm wide due to the usage of sleeveless phaco tip (without irrigation) and irrigation chopper. The advantage of separation the irrigation from aspiration is improvement of liquid dynamics in the anterior chamber. Moreover, due to the usage of the irrigation chopper, in B-MICS it is possible to lower the mean ultrasound energy. In coaxial technique MICS phacoemulsification is performed through the incision 1.8 mm wide with usage of phaco tip with a silicon irrigation sleeve. The aim of the study is to compare functional results and complications of 3 methods of cataract phacoemulsification: bimanual 1.4 mm cataract surgery (B-MICS), coaxial 1.8 mm cataract surgery (C-MICS) and coaxial 2.4 mm small incision cataract surgery. Moreover, this study aimed to evaluate the impact of corneal width on best corrected visual acuity (uncorrected and corrected), surgically induced astigmatism, endothelial cell loss, intraocular pressure, anterior segment of the eye and central retinal thickness.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract, Corneal Astigmatism, Corneal Incision Contracture
    Keywords
    surgically induced astigmatism, phacoemulsification, bimanual microincision cataract surgery, coaxial microincision cataract surgery, small incision cataract surgery, clear corneal incision

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    B-MICS 1.4 mm
    Arm Type
    Experimental
    Arm Description
    bimanual 1.4 mm cataract surgery (B-MICS)
    Arm Title
    C-MICS 1.8 mm
    Arm Type
    Active Comparator
    Arm Description
    coaxial 1.8 mm cataract surgery (C-MICS)
    Arm Title
    C-SICS 2.4 mm
    Arm Type
    Active Comparator
    Arm Description
    coaxial 2.4 mm small incision cataract surgery (C-SICS)
    Intervention Type
    Procedure
    Intervention Name(s)
    Bimanual 1.4 mm microincision cataract surgery (B-MICS) with IOL implantation in a "wound-assisted" technique. In bimanual MICS group a self-sealing 1.4 mm wide incision was created supratemporally
    Intervention Description
    microincision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch & Lomb
    Intervention Type
    Procedure
    Intervention Name(s)
    Coaxial 1.8 mm microincision cataract surgery (C-MICS) with IOL implantation with an injector through the 1.8 mm wide incision created temporally.
    Intervention Description
    microincision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch & Lomb
    Intervention Type
    Procedure
    Intervention Name(s)
    Coaxial 2.4 mm small incision cataract surgery (C-SICS) with IOL implantation with an injector through the 2.4 mm wide incision located temporally.
    Intervention Description
    small incision cataract surgery (phacoemulsification) with implantation of a foldable, acrylic, hydrophilic IOL Incise® MJ14, Bausch & Lomb
    Primary Outcome Measure Information:
    Title
    the best corrected visual acuity
    Description
    examined with digital Snellen chart, measured in decimal scale
    Time Frame
    36 months
    Title
    the best uncorrected visual acuity
    Description
    examined with digital Snellen chart, measured in decimal scale
    Time Frame
    36 months
    Title
    autorefractometry
    Description
    measured in diopters (D)
    Time Frame
    36 months
    Title
    keratometry
    Description
    measured in diopters (D)
    Time Frame
    36 months
    Title
    intraocular pressure (IOP)
    Description
    measured in millimeters of mercury (mmHg)
    Time Frame
    36 months
    Title
    endothelial cell density (ECD)
    Description
    measured in endothelial cells/mm2
    Time Frame
    36 months
    Title
    central corneal thickness (CCT)
    Description
    measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers).
    Time Frame
    36 months
    Title
    peripheral temporal corneal thickness
    Description
    measured at the main incision site with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
    Time Frame
    36 months
    Title
    peripheral nasal corneal thickness
    Description
    measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
    Time Frame
    36 months
    Title
    anterior chamber depth (ACD)
    Description
    measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in mm (milimeters).
    Time Frame
    36 months
    Title
    the white-to-white (WTW) distance - the horizontal corneal diameter
    Description
    measured with Anterior Segment Optical Coherence Tomography (AS-OCT, unit of measure: mm (milimeters).
    Time Frame
    36 months
    Title
    length of the clear corneal incision
    Description
    the chord length measured with Anterior Segment Optical Coherence Tomography (AS-OCT), unit of measure: µm (micrometers)
    Time Frame
    36 months
    Title
    anterior chamber angle
    Description
    measured with Anterior Segment Optical Coherence Tomography (AS-OCT) in horizontal scan, unit of measure: degrees
    Time Frame
    36 months
    Title
    central foveal thickness (CFT)
    Description
    measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
    Time Frame
    36 months
    Title
    parafoveal retinal thickness
    Description
    measured with Optical Coherence Tomography (OCT), unit of measure: µm (micrometers)
    Time Frame
    36 months
    Secondary Outcome Measure Information:
    Title
    surgically induced astigmatism SIA
    Description
    measured in dioptres (D) - three different methods were used for calculation of surgically induced astigmatism (SIA): vector analysis method, vector decomposition method (C90), Naeser's polar values method (dKP-90)
    Time Frame
    36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    87 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: lens opacities which were an indication for cataract surgery and absence of exclusion criteria, cataract sclerosis grade from II to IV in Lens Opacities Classification System LOCS III scale (The Lens Opacities Classification System III). Exclusion Criteria: history of ocular surgery, ocular trauma, congenital ocular malformations, amblyopia, corneal disorders (including corneal opacities and scars), best corrected visual acuity (BCVA) ≥ 0.9, preoperative endothelial cell density <1500 cells/mm2, history of uveitis, diabetic retinopathy, retinal and macular disorders, eventful phacoemulsification presence of other diseases that could affect the postoperative visual outcomes.

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of the Impact of Corneal Width on Surgically Induced Astigmatism (SIA) and Functional Results After Bimanual 1.4 mm Microincision Cataract Surgery (B-MICS), Coaxial 1.8 mm MICS (C-MICS) and 2.4 mm Small Incision Cataract Surgery (C-SICS).

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