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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

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.

Condition or disease Intervention/treatment Phase
Cataract Presbyopia Procedure: cataract surgery Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : February 25, 2016
Actual Study Completion Date : September 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
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.
Procedure: cataract surgery
cataract surgery with phacoemulsification and implantation of multifocal posterior chamber intraocular lens

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.
Procedure: cataract surgery
cataract surgery with phacoemulsification and implantation of multifocal posterior chamber intraocular lens




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Semmelweis University
ClinicalTrials.gov Identifier: NCT03297086     History of Changes
Other Study ID Numbers: Kappa1
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Semmelweis University:
multifocal intraocular lens, angle kappa, presbyopia
Additional relevant MeSH terms:
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Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors