Comparisons of the Astigmatic Power of Toric Intraocular Lens Using Three Toric Calculators: AcrySof, TECNIS, and iTrace Toric Calculator
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 31, 2013
CompletedFirst Posted
Study publicly available on registry
November 7, 2013
CompletedNovember 7, 2013
November 1, 2013
3 months
October 31, 2013
November 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- Subjects who planned to undergo cataract removal by phacoemulsification
- Subjects with preoperative corneal astigmatism greater than 0.75 D, as determined by autokeratometry
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
Seoul, 120-752, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2013
First Posted
November 7, 2013
Study Start
January 1, 2013
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
November 7, 2013
Record last verified: 2013-11