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Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses

Primary Purpose

Cataract, Presbyopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cataract surgery
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring multifocal intraocular lens, angle kappa, presbyopia

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with age related cataract and presbyopia

Exclusion Criteria:

  • Patients with previous ocular surgery, trauma, active ocular disease, poorly dilated pupils, or known zonular weakness and corneal astigmatism >1.5 diopters were excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Bi-Flex

    ReStor

    Arm Description

    Medicontur Bi-Flex 677MY IOL was implanted into 24 eyes of 12 patients during cataract surgery. Angle kappa, biometric data and IOL decantation were measured.

    and Alcon Acrysof Restor SN6AD1 IOL was implanted into 36 eyes of 18 patients during cataract surgery. Angle kappa, biometric data and IOL decantation were measured.

    Outcomes

    Primary Outcome Measures

    Measurement of changes of angle kappa after multifocal intraocular lens implantation.
    Changes in magnitude and orientation of angle kappa (deviation between the visual and pupillary axis) are measured before and after cataract surgery with multifoocal intraocular lens implantation. During pre-and postoperative examination optical biometry is carried out using Lenstar LS 900. Optical biometer determines deviation between the visual and pupillary axis that represents angle kappa. Deviation of these axes can be defined by its magnitude and orientation. Location of the pupil centre relative to the visual axis - the reference axis - is determined by x- and y-offsets using trigonometrical analysis.

    Secondary Outcome Measures

    Determination of influencing effect of biometrical data on postoperative visual axis shift
    Biometry data (axial length, keratometry, lens thickness, anterior chamber depth) are measured preoperatively by Lenstar LS 900 optical biometer. Their effect on changes of angle kappa is determined using statistical analysis.
    Determination of influencing effect of intraocular lens decentration on postoperative visual axis shift
    Three months after cataract surgery postoperative intraocular lens (IOL) position is determined using a rotating Scheimpflug-camera (Galilei G4). IOL decentration is obtained from the distance between the IOL centre and visual axis. The effect of possible IOL decentration on changes of angle kappa is determined using statistical analysis.

    Full Information

    First Posted
    September 12, 2017
    Last Updated
    September 25, 2017
    Sponsor
    Semmelweis University
    Collaborators
    Medicontur Kft
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03297086
    Brief Title
    Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses
    Official Title
    Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2015 (Actual)
    Primary Completion Date
    February 25, 2016 (Actual)
    Study Completion Date
    September 11, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Semmelweis University
    Collaborators
    Medicontur Kft

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate possible changes of angle kappa after multifocal intraocular lens implantation. Presumable influencing factors of postoperative visual axis shift (ie. biometric parameters of the eye) are investigated to determine the degree and direction of angle kappa alterations.
    Detailed Description
    The purpose of this study is to evaluate changes of angle kappa after multifocal intraocular lens implantation. During cataract surgery Medicontur Bi-Flex 677MY IOL and Alcon Acrysof Restor SN6AD1 IOL are implanted. Optical biometry is carried out for IOL calculation and to measure axial length and angle kappa. Three months after surgery biometry is repeated, IOL position and angle kappa are measured using Scheimpflug-camera.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract, Presbyopia
    Keywords
    multifocal intraocular lens, angle kappa, presbyopia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bi-Flex
    Arm Type
    Active Comparator
    Arm Description
    Medicontur Bi-Flex 677MY IOL was implanted into 24 eyes of 12 patients during cataract surgery. Angle kappa, biometric data and IOL decantation were measured.
    Arm Title
    ReStor
    Arm Type
    Active Comparator
    Arm Description
    and Alcon Acrysof Restor SN6AD1 IOL was implanted into 36 eyes of 18 patients during cataract surgery. Angle kappa, biometric data and IOL decantation were measured.
    Intervention Type
    Procedure
    Intervention Name(s)
    cataract surgery
    Intervention Description
    cataract surgery with phacoemulsification and implantation of multifocal posterior chamber intraocular lens
    Primary Outcome Measure Information:
    Title
    Measurement of changes of angle kappa after multifocal intraocular lens implantation.
    Description
    Changes in magnitude and orientation of angle kappa (deviation between the visual and pupillary axis) are measured before and after cataract surgery with multifoocal intraocular lens implantation. During pre-and postoperative examination optical biometry is carried out using Lenstar LS 900. Optical biometer determines deviation between the visual and pupillary axis that represents angle kappa. Deviation of these axes can be defined by its magnitude and orientation. Location of the pupil centre relative to the visual axis - the reference axis - is determined by x- and y-offsets using trigonometrical analysis.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Determination of influencing effect of biometrical data on postoperative visual axis shift
    Description
    Biometry data (axial length, keratometry, lens thickness, anterior chamber depth) are measured preoperatively by Lenstar LS 900 optical biometer. Their effect on changes of angle kappa is determined using statistical analysis.
    Time Frame
    3 months
    Title
    Determination of influencing effect of intraocular lens decentration on postoperative visual axis shift
    Description
    Three months after cataract surgery postoperative intraocular lens (IOL) position is determined using a rotating Scheimpflug-camera (Galilei G4). IOL decentration is obtained from the distance between the IOL centre and visual axis. The effect of possible IOL decentration on changes of angle kappa is determined using statistical analysis.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with age related cataract and presbyopia Exclusion Criteria: Patients with previous ocular surgery, trauma, active ocular disease, poorly dilated pupils, or known zonular weakness and corneal astigmatism >1.5 diopters were excluded from the study.

    12. IPD Sharing Statement

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    Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses

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