Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03297086

Enrollment

Registered

2017-09-29

Start date

2015-12-01

Completion date

2017-09-11

Last updated

2017-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Presbyopia

Keywords

multifocal intraocular lens, angle kappa, presbyopia

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.

Interventions

PROCEDUREcataract surgery

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Measurement of changes of angle kappa after multifocal intraocular lens implantation.	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

Measure	Time frame	Description
Determination of influencing effect of biometrical data on postoperative visual axis shift	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	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026