NCT01978106

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
Last Updated

November 7, 2013

Status Verified

November 1, 2013

Enrollment Period

3 months

First QC Date

October 31, 2013

Last Update Submit

November 6, 2013

Conditions

Keywords

toric calculatortoric intraocular lens powerAcrysofTecnisiTrace

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

Age33 Years - 87 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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

Location

MeSH Terms

Conditions

CataractAstigmatism

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

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

Locations