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Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses

NCT ID: NCT03297086

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2017-09-11

Brief Summary

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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

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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.

Conditions

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Cataract Presbyopia

Keywords

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multifocal intraocular lens, angle kappa, presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

cataract surgery

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

cataract surgery

Intervention Type PROCEDURE

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

Interventions

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cataract surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medicontur Kft

UNKNOWN

Sponsor Role collaborator

Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Kappa1

Identifier Type: -

Identifier Source: org_study_id