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Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses

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ClinicalTrials.gov Identifier: NCT03297086
Recruitment Status : Completed
First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Sponsor:
Collaborator:
Medicontur Kft
Information provided by (Responsible Party):
Semmelweis University

Tracking Information
First Submitted Date  ICMJE September 12, 2017
First Posted Date  ICMJE September 29, 2017
Last Update Posted Date September 29, 2017
Actual Study Start Date  ICMJE December 1, 2015
Actual Primary Completion Date February 25, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2017)
Measurement of changes of angle kappa after multifocal intraocular lens implantation. [ Time Frame: 3 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2017)
  • Determination of influencing effect of biometrical data on postoperative visual axis shift [ Time Frame: 3 months ]
    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 [ Time Frame: 3 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses
Official Title  ICMJE Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cataract
  • Presbyopia
Intervention  ICMJE Procedure: cataract surgery
cataract surgery with phacoemulsification and implantation of multifocal posterior chamber intraocular lens
Study Arms  ICMJE
  • Active Comparator: Bi-Flex
    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.
    Intervention: Procedure: cataract surgery
  • Active Comparator: ReStor
    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: Procedure: cataract surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2017)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 11, 2017
Actual Primary Completion Date February 25, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03297086
Other Study ID Numbers  ICMJE Kappa1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Semmelweis University
Study Sponsor  ICMJE Semmelweis University
Collaborators  ICMJE Medicontur Kft
Investigators  ICMJE Not Provided
PRS Account Semmelweis University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP