Comparisons of the Astigmatic Power of Toric Intraocular Lens Using Three Toric Calculators: AcrySof, TECNIS, and iTrace Toric Calculator

November 6, 2013 updated by: Yonsei University
Purpose of this study is to compare the astigmatic power of the toric IOL obtained from the AcrySof toric calculator, TECNIS toric calculator, and iTrace toric calculator in a group of patients with preoperative with-the-rule (WTR) and against-the-rule (ATR) corneal astigmatism. The study included 100 eyes with cataract and greater than 0.75 diopter of corneal astigmatism, and the subjects were divided into WTR and ATR group. Keratometric value was measured using autokeratometry, IOLMaster partial coherence interferometry (PCI), iTrace incorporating corneal topography and ray-tracing aberrometry. Based on measured values, toric IOL power calculations were performed using AcrySof, TECNIS and iTrace toric calculators.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine

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

33 years to 87 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects who planned to undergo cataract removal by phacoemulsification between January 2013 to April 2013 at the Department of Ophthalmology, Yonsei University College of Medicine, Seoul, South Korea were included in this study.

Description

Inclusion Criteria:

  • Subjects who planned to undergo cataract removal by phacoemulsification
  • Subjects with preoperative corneal astigmatism greater than 0.75 D, as determined by autokeratometry

Exclusion Criteria:

  • Subjects with more than 2.74 D of corneal keratometric value from autokeratometry
  • a history of intraocular or corneal surgery and ocular trauma
  • biomicroscopic evidence of corneal disease that could affect corneal astigmatisms
  • contact lens wearer

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
a WTR corneal astigmatism group
Corneal astigmatism was defined as WTR when the steep corneal cylinder axis was within 30 degrees of the horizontal axis.
an ATR corneal astigmatism group
Corneal astigmatism was defined as ATR when the cylinder axis was within 30 degrees of the vertical axis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of toric intraocular lens power between three toric calculators
Time Frame: Immediately after measurement
Comparison of the toric intraocular lens power calculated from Acrysof and TECNIS toric calculators using keratometric values measured by autokeratometry or IOLMaster PCI and that from iTrace toric calculator with keratometric value measurement using iTrace ray tracing wavefront aberrometry and iTrace simulated keratometry.
Immediately after measurement

Collaborators and Investigators

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

Sponsor

Yonsei University

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

January 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (Estimate)

November 7, 2013

Study Record Updates

Last Update Posted (Estimate)

November 7, 2013

Last Update Submitted That Met QC Criteria

November 6, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2013-0041

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.

Clinical Trials on Cataract

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe