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
About this trial
This is an interventional treatment trial for Cataract focused on measuring multifocal intraocular lens, angle kappa, presbyopia
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.
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
NCT ID
NCT03297086
First Posted
September 12, 2017
Last Updated
September 25, 2017
Sponsor
Semmelweis University
Collaborators
Medicontur Kft
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
Learn more about this trial
Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses
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