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

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ClinicalTrials.gov Identifier: NCT01978106
Recruitment Status : Completed
First Posted : November 7, 2013
Last Update Posted : November 7, 2013
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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.

Condition or disease
Cataract Astigmatism

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : January 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   33 Years to 87 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978106


Locations
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Korea, Republic of
Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01978106     History of Changes
Other Study ID Numbers: 1-2013-0041
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: November 7, 2013
Last Verified: November 2013

Keywords provided by Yonsei University:
toric calculator
toric intraocular lens power
Acrysof
Tecnis
iTrace

Additional relevant MeSH terms:
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Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors