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Mix and Match Study of Two Multifocal Intraocular Lens With Different Add Power

Primary Purpose

Presbyopia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Phacoemulsification with multifocal intraocular lens
Sponsored by
tae-young chung
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Depth of focus

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Age-related cataract

    • Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye.
    • A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation.
    • A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
    • Written informed consent to surgery and participation in the study

Exclusion Criteria:

  • • Pregnant woman and lactating woman

    • A patient with history of retinal disease
    • A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye
    • A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye.
    • A patient that has been wearing PMMA lenses within 6 months, gas permeable lenses within one month, or extended -wear or daily soft contact lens within 7 days of their scheduled surgery.
    • Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract, or marfan syndrome
    • Those who are not able to read and understand the informed consent (illiterate or foreigners)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Mix and matched patients

    Arm Description

    Mix and matched patients will get phacoemulsification with multifocal intraocular lens implantation with two different add power (+2.75 diopters (D) or +3.25 D, respectively) in each eye of a patient, contralaterally.

    Outcomes

    Primary Outcome Measures

    Visual acuity(Distant, intermediate, near)

    Secondary Outcome Measures

    Visual acuity(Distant, intermediate, near)

    Full Information

    First Posted
    September 21, 2015
    Last Updated
    September 21, 2015
    Sponsor
    tae-young chung
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02556944
    Brief Title
    Mix and Match Study of Two Multifocal Intraocular Lens With Different Add Power
    Official Title
    Mix and Match Study of Two Multifocal Intraocular Lens With Different Add Power
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    April 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    tae-young chung

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To assess postsurgical visual acuity (distant, intermediate, near), refractive errors, contrast sensitivity, visual function and patient satisfaction after implantation of multifocal IOLs of different add power contralaterally.
    Detailed Description
    Multifocal intraocular lens (MIOL) is considered a prevailing alternative to restore the functional vision from far to near independent of glasses. Many clinical studies on diffractive MIOLs, refractive MIOLs, or hybrid MIOLs in enhancing quality of vision showed promising outcomes. Several studies have confirmed the satisfactory visual outcomes of Tecnis MIOL with +4.00 D add power. The purpose of study is to assess the visual performance after cataract surgery with bilateral implantation of multifocal IOL with two different add power (+2.75 D or +3.25 D) in one patient.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Presbyopia
    Keywords
    Depth of focus

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Mix and matched patients
    Arm Type
    Experimental
    Arm Description
    Mix and matched patients will get phacoemulsification with multifocal intraocular lens implantation with two different add power (+2.75 diopters (D) or +3.25 D, respectively) in each eye of a patient, contralaterally.
    Intervention Type
    Device
    Intervention Name(s)
    Phacoemulsification with multifocal intraocular lens
    Intervention Description
    Phacoemulsification and implantation of a multifocal intraocular lens (IOL) with two different add power (+2.75 diopters (D) or +3.25 D, respectively) in each eye of a patient, contralaterally. They're called mix and matched patients.
    Primary Outcome Measure Information:
    Title
    Visual acuity(Distant, intermediate, near)
    Time Frame
    1month
    Secondary Outcome Measure Information:
    Title
    Visual acuity(Distant, intermediate, near)
    Time Frame
    3month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Age-related cataract Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye. A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation. A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters Written informed consent to surgery and participation in the study Exclusion Criteria: • Pregnant woman and lactating woman A patient with history of retinal disease A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye. A patient that has been wearing PMMA lenses within 6 months, gas permeable lenses within one month, or extended -wear or daily soft contact lens within 7 days of their scheduled surgery. Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract, or marfan syndrome Those who are not able to read and understand the informed consent (illiterate or foreigners)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tae-Young Chung, PhD
    Organizational Affiliation
    Samsung Medical Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29514611
    Citation
    Yang CM, Lim DH, Hwang S, Hyun J, Chung TY. Prospective study of bilateral mix-and-match implantation of diffractive multifocal intraocular lenses in Koreans. BMC Ophthalmol. 2018 Mar 7;18(1):73. doi: 10.1186/s12886-018-0735-0.
    Results Reference
    derived

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    Mix and Match Study of Two Multifocal Intraocular Lens With Different Add Power

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