search
Back to results

Clinical Evaluation of Toric Intraocular Lens

Primary Purpose

Cataract, Astigmatism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
toric intraocular lens
Sponsored by
Nidek Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with age of 40 years or older
  • Patients with age-related cataract in one eye or both eyes.
  • Patients willing to participate in the required postoperative study.
  • Patient who can understand and sign the consent document.
  • An eye whose pupil diameter after mydriasis is 5 mm or greater.
  • An eye whose preoperative corneal cylindrical power is 1.0D or more.
  • An eye whose postoperative astigmatism is predicted to be less than 0.5 D.
  • An eye whose postoperative visual acuity with spherical addition is 0.8 D or more.

Exclusion Criteria:

  • Disorder of corneal endothelium
  • Uncontrolled glaucoma
  • Active Uveitis
  • Diabetic retinopathy
  • Retinal detachment
  • Congenital ocular anomalies
  • Choroidal hemorrhage
  • Shallow anterior chamber
  • Microphthalmus
  • Corneal dystrophy
  • Optic atrophy
  • Ocular hypertension
  • Amblyopia
  • Previous history of corneal transplantation
  • Active Iritis
  • Corneal disorder
  • Macular degeneration
  • Retinal degeneration
  • Clinically significant change in macula and/or retinal pigment epithelium
  • Corneal irregular astigmatism
  • Atopic disease
  • Brittleness of Zinn's zonule, fractured zonule and lens luxation (including subluxation)
  • Pseudo-exfoliation syndrome
  • Iris neovascularization
  • Long axis length eye (axis length : 28mm or more)
  • Severe dry eye, abnormality of the lens surface
  • Concurrent participation in another drug and device clinical investigation
  • Patient with mental deficiency or psychiatric disorder and/or who is not capable of expressing the consent of participating in the trial
  • Patient who is judged inappropriate by investigators or sub-investigators

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    toric intraocular lens

    Arm Description

    toric intraocular lens is implanted to all subjects

    Outcomes

    Primary Outcome Measures

    Visual acuity
    Visual acuity with pre-determined spherical correction

    Secondary Outcome Measures

    Visual acuity
    UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent
    IOL rotation
    angle of rotation

    Full Information

    First Posted
    June 16, 2017
    Last Updated
    February 18, 2018
    Sponsor
    Nidek Co. LTD.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03242486
    Brief Title
    Clinical Evaluation of Toric Intraocular Lens
    Official Title
    Safety and Effectiveness Evaluation of Toric Intraocular Lens
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (Actual)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nidek Co. LTD.

    4. Oversight

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

    5. Study Description

    Brief Summary
    Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal astigmatism after cataract surgery.
    Detailed Description
    Effectiveness primary endpoint is visual acuity with pre-determined spherical correction. secondary endpoint is UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent, IOL rotation Safety number and percentage of adverse event

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract, Astigmatism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    toric intraocular lens
    Arm Type
    Experimental
    Arm Description
    toric intraocular lens is implanted to all subjects
    Intervention Type
    Device
    Intervention Name(s)
    toric intraocular lens
    Primary Outcome Measure Information:
    Title
    Visual acuity
    Description
    Visual acuity with pre-determined spherical correction
    Time Frame
    postoperative 6 months
    Secondary Outcome Measure Information:
    Title
    Visual acuity
    Description
    UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent
    Time Frame
    postoperative 6 months
    Title
    IOL rotation
    Description
    angle of rotation
    Time Frame
    postoperative 6 months
    Other Pre-specified Outcome Measures:
    Title
    Adverse events
    Description
    Severity and causal relationship
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with age of 40 years or older Patients with age-related cataract in one eye or both eyes. Patients willing to participate in the required postoperative study. Patient who can understand and sign the consent document. An eye whose pupil diameter after mydriasis is 5 mm or greater. An eye whose preoperative corneal cylindrical power is 1.0D or more. An eye whose postoperative astigmatism is predicted to be less than 0.5 D. An eye whose postoperative visual acuity with spherical addition is 0.8 D or more. Exclusion Criteria: Disorder of corneal endothelium Uncontrolled glaucoma Active Uveitis Diabetic retinopathy Retinal detachment Congenital ocular anomalies Choroidal hemorrhage Shallow anterior chamber Microphthalmus Corneal dystrophy Optic atrophy Ocular hypertension Amblyopia Previous history of corneal transplantation Active Iritis Corneal disorder Macular degeneration Retinal degeneration Clinically significant change in macula and/or retinal pigment epithelium Corneal irregular astigmatism Atopic disease Brittleness of Zinn's zonule, fractured zonule and lens luxation (including subluxation) Pseudo-exfoliation syndrome Iris neovascularization Long axis length eye (axis length : 28mm or more) Severe dry eye, abnormality of the lens surface Concurrent participation in another drug and device clinical investigation Patient with mental deficiency or psychiatric disorder and/or who is not capable of expressing the consent of participating in the trial Patient who is judged inappropriate by investigators or sub-investigators

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35033047
    Citation
    Sugita I, Ogawa T, Ichikawa K, Okita T, Negishi K, Nakano T, Tsuneoka H. Rotational stability and clinical outcomes of a new one piece toric intraocular lens with anchor-wing haptics. BMC Ophthalmol. 2022 Jan 15;22(1):26. doi: 10.1186/s12886-021-02240-7.
    Results Reference
    derived

    Learn more about this trial

    Clinical Evaluation of Toric Intraocular Lens

    We'll reach out to this number within 24 hrs