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

Cataract Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978106
• Other study ID #: 1-2013-0041
• Status: Completed
• Phase: N/A
• First received: October 31, 2013
• Last updated: November 6, 2013
• Start date: January 2013
• Est. completion date: April 2013

Study information

• Verified date: November 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 33 Years to 87 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Locations

Country	Name	City	State
Korea, Republic of	Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of toric intraocular lens power between three toric calculators	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	No