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Comparison of Clinical Outcomes of Toric Intraocular Lens

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Precizon toric intraocular lens
Tecnis toric intraocular lens
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

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

Inclusion Criteria:

  • Patient with cataract and regular corneal astigmatism(between 0.50 diopter and 2.50 diopter considering both anterior and posterior corneal surface)

Exclusion Criteria:

  • Amblyopia, irregular astigmatism, corneal opacity, glaucoma, retinal disease, history of ocular inflammation, previous other intraocular surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Precizon toric intraocular lens

    Tecnis toric intraocular lens

    Arm Description

    Cataract surgery and implantation of Precizon toric intraocular lens

    Cataract surgery and implantation of Tecnis toric intraocular lens

    Outcomes

    Primary Outcome Measures

    Postoperative refractive astigmatism
    Diopter

    Secondary Outcome Measures

    Postoperative visual acuity
    logMAR

    Full Information

    First Posted
    March 11, 2017
    Last Updated
    March 15, 2017
    Sponsor
    Samsung Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03085901
    Brief Title
    Comparison of Clinical Outcomes of Toric Intraocular Lens
    Official Title
    Comparison of Clinical Outcomes of Toric Intraocular Lens
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2016 (Actual)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    October 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Samsung Medical Center

    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
    This study is to compare the clinical outcome of Precizon toric intraocular lens(IOL) to that of Tecnis toric IOL.
    Detailed Description
    In cataract surgery, after phacoemulsification, intraocular lens should be implanted for patient's better visual acuity. When patient has large amount of corneal astigmatism, toric intraocular lens are recommended to correct the preexisting astigmatism.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Precizon toric intraocular lens
    Arm Type
    Active Comparator
    Arm Description
    Cataract surgery and implantation of Precizon toric intraocular lens
    Arm Title
    Tecnis toric intraocular lens
    Arm Type
    Active Comparator
    Arm Description
    Cataract surgery and implantation of Tecnis toric intraocular lens
    Intervention Type
    Device
    Intervention Name(s)
    Precizon toric intraocular lens
    Intervention Description
    Phacoemulsification and implantation of Precizon toric intraocular lens
    Intervention Type
    Device
    Intervention Name(s)
    Tecnis toric intraocular lens
    Intervention Description
    Phacoemulsification and implantation of Tecnis toric intraocular lens
    Primary Outcome Measure Information:
    Title
    Postoperative refractive astigmatism
    Description
    Diopter
    Time Frame
    postoperative 3 months
    Secondary Outcome Measure Information:
    Title
    Postoperative visual acuity
    Description
    logMAR
    Time Frame
    postoperative 3 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient with cataract and regular corneal astigmatism(between 0.50 diopter and 2.50 diopter considering both anterior and posterior corneal surface) Exclusion Criteria: Amblyopia, irregular astigmatism, corneal opacity, glaucoma, retinal disease, history of ocular inflammation, previous other intraocular surgery

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30413154
    Citation
    Jung NY, Lim DH, Hwang SS, Hyun J, Chung TY. Comparison of clinical outcomes of toric intraocular lens, Precizon vs Tecnis: a single center randomized controlled trial. BMC Ophthalmol. 2018 Nov 9;18(1):292. doi: 10.1186/s12886-018-0955-3.
    Results Reference
    derived

    Learn more about this trial

    Comparison of Clinical Outcomes of Toric Intraocular Lens

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