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Comparison Between TICL and ICL+AK for High Myopic Astigmatism

Primary Purpose

Astigmatism, High Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Toric Implantable Collamer Lens
ICL + Astigmatic keratotomy
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism focused on measuring astigmatism, high myopia, phakic intraocular lens, astigmatic keratotomy, toric

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age ranged from 18 to 40 years,
  • myopia greater than -8.00 diopters (D), and refractive cylinder in the range of 1.50D to 5.50D,
  • for the patients who were planned to undergo AK+ICL implantation, the axial difference between the corneal astigmatism and the manifest refractive astigmatism was less than 10 degree,
  • a stable refractive error during the previous 2 years,
  • anterior chamber depth more than 2.8 mm,
  • endothelial cell density (ECD) more than 2500 cells/mm2, and
  • scotopic pupillary diameter less than 7 mm.

Exclusion Criteria:

  • subjects had significant irregular astigmatism, corneal pathological changes, glaucoma, ocular inflammation, or previous ocular trauma or surgery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Toric Implantable Collamer Lens

    ICL+ Astigmatic keratotomy

    Arm Description

    Subjects in this group will implant Toric Implantable Collamer Lens for high myopic astigmatism

    Subjects in this group will implant Implantable Collamer Lens and combined with astigmatic keratotomy for high myopic astigmatism

    Outcomes

    Primary Outcome Measures

    Uncorrected Visual Acuity (UCVA) at distance
    measured at 5 meter
    astigmatism
    astigmatism getting from subjective refraction

    Secondary Outcome Measures

    Best Corrected Visual Acuity (BCVA) at distance
    subjective refraction
    Spherical Equivalent (SE)
    subjective refraction
    mean postoperative BCVA/mean preoperative BCVA
    safety index
    mean postoperative UCVA/mean preoperative BCVA
    efficacy index

    Full Information

    First Posted
    June 22, 2017
    Last Updated
    June 27, 2017
    Sponsor
    Wenzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03202485
    Brief Title
    Comparison Between TICL and ICL+AK for High Myopic Astigmatism
    Official Title
    Comparison Between Toric and Spherical Implantable Collamer Lens Combined With Astigmatic Keratotomy for High Myopic Astigmatism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 3, 2014 (Actual)
    Primary Completion Date
    March 2, 2015 (Actual)
    Study Completion Date
    January 1, 2017 (Actual)

    3. Sponsor/Collaborators

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

    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
    To compare the outcomes of a toric Implantable Collamer Lens (ICL) and a spherical Implantable Collamer Lens combined with astigmatic keratotomy (AK) in the correction of high myopic astigmatism.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Astigmatism, High Myopia
    Keywords
    astigmatism, high myopia, phakic intraocular lens, astigmatic keratotomy, toric

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective comparative case series
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Toric Implantable Collamer Lens
    Arm Type
    Active Comparator
    Arm Description
    Subjects in this group will implant Toric Implantable Collamer Lens for high myopic astigmatism
    Arm Title
    ICL+ Astigmatic keratotomy
    Arm Type
    Experimental
    Arm Description
    Subjects in this group will implant Implantable Collamer Lens and combined with astigmatic keratotomy for high myopic astigmatism
    Intervention Type
    Device
    Intervention Name(s)
    Toric Implantable Collamer Lens
    Intervention Description
    uses Toric Implantable Collamer Lens implantation to correct the high myopic astigmatism.
    Intervention Type
    Device
    Intervention Name(s)
    ICL + Astigmatic keratotomy
    Intervention Description
    uses Implantable Collamer Lens implantation combined with Astigmatic keratotomy to correct the high myopic astigmatism
    Primary Outcome Measure Information:
    Title
    Uncorrected Visual Acuity (UCVA) at distance
    Description
    measured at 5 meter
    Time Frame
    2 years after surgery
    Title
    astigmatism
    Description
    astigmatism getting from subjective refraction
    Time Frame
    2 years after surgery
    Secondary Outcome Measure Information:
    Title
    Best Corrected Visual Acuity (BCVA) at distance
    Description
    subjective refraction
    Time Frame
    2 years after surgery
    Title
    Spherical Equivalent (SE)
    Description
    subjective refraction
    Time Frame
    2 years after surgery
    Title
    mean postoperative BCVA/mean preoperative BCVA
    Description
    safety index
    Time Frame
    2 years after surgery
    Title
    mean postoperative UCVA/mean preoperative BCVA
    Description
    efficacy index
    Time Frame
    2 years after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age ranged from 18 to 40 years, myopia greater than -8.00 diopters (D), and refractive cylinder in the range of 1.50D to 5.50D, for the patients who were planned to undergo AK+ICL implantation, the axial difference between the corneal astigmatism and the manifest refractive astigmatism was less than 10 degree, a stable refractive error during the previous 2 years, anterior chamber depth more than 2.8 mm, endothelial cell density (ECD) more than 2500 cells/mm2, and scotopic pupillary diameter less than 7 mm. Exclusion Criteria: subjects had significant irregular astigmatism, corneal pathological changes, glaucoma, ocular inflammation, or previous ocular trauma or surgery.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    AYong Yu, MD.PhD.
    Organizational Affiliation
    Wenzhou Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28828390
    Citation
    Zheng LY, Zhu SQ, Su YF, Zou HY, Wang QM, Yu AY. Comparison between toric and spherical phakic intraocular lenses combined with astigmatic keratotomy for high myopic astigmatism. Eye Vis (Lond). 2017 Aug 18;4:20. doi: 10.1186/s40662-017-0085-7. eCollection 2017.
    Results Reference
    derived

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    Comparison Between TICL and ICL+AK for High Myopic Astigmatism

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