Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses

Cataract Clinical Trial

Official title:

Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297086
• Other study ID #: Kappa1
• Status: Completed
• Phase: N/A
• First received: September 12, 2017
• Last updated: September 25, 2017
• Start date: December 1, 2015
• Est. completion date: September 11, 2017

Study information

• Verified date: September 2017
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 11, 2017
• Est. primary completion date: February 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Presbyopia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Semmelweis University	Medicontur Kft

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months