Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses

NCT03297086 | Completed

• 1 other identifier: Kappa1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract; Presbyopia

Keywords

multifocal intraocular lens, angle kappa, presbyopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determination of influencing effect of biometrical data on postoperative visual axis shift

  3 months

• Determination of influencing effect of intraocular lens decentration on postoperative visual axis shift

  3 months

Study Arms (2)

Bi-Flex

ACTIVE COMPARATOR

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

ReStor

ACTIVE COMPARATOR

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

Interventions

cataract surgery PROCEDURE

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

Bi-Flex; ReStor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with age related cataract and presbyopia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semmelweis University: lead
• Medicontur Kft: collaborator

MeSH Terms

Conditions

Cataract; Presbyopia

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 29, 2017
• Study Start: December 1, 2015
• Primary Completion: February 25, 2016
• Study Completion: September 11, 2017
• Last Updated: September 29, 2017

Record last verified: 2017-09