The Clinical Importance of Angle Alpha by Multifocal Intraocular Lenses.

February 19, 2020 updated by: Kata Mihaltz, Hospital Hietzing

The Impact of Visual Axis Position on the Optical Quality After Implantation of Multifocal Intraocular Lenses With Different Asphericity Values

Purpose: to evaluate the effect of visual axis positioning on the optical performance of the Tecnis MIOL and the Diff-aA MIOL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this prospective, randomized comparative study 70 eyes of 35 subjects with senile cataract were implanted with the spherical aberration correcting diffractive, bifocal Tecnis ZLB00 IOL, and 60 eyes of 30 age matched subjects with the spherical aberration neutral, diffractive, bifocal Diffractiva IOL. Observation Procedure was performed 1, 3, 6 months postoperatively. Main Outcome Measures included uncorrected and corrected distance and near visual acuity, manifest refraction, ocular aberrations and visual quality metrics with 2mm and 4mm pupil, and the position of visual axis.

Study Type

Observational

Enrollment (Actual)

65

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients of the clinic

Description

Inclusion Criteria:

  • corneal astigmatism less than 1 diopter

Exclusion Criteria:

  • ocular pathology others than cataract

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tecnis;
Patients who received the Tecnis multifocal IOL.
Procedure: Cataract surgery
Phacoemulsification surgery
Diffractiva
Patients who received the Diffractiva multifocal IOL.
Procedure: Cataract surgery
Phacoemulsification surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 6 Month
Schnellen VA
6 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Hietzing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 17, 2020

First Posted (Actual)

February 18, 2020

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHietzing3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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