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Clinical Trials/NCT01045733
NCT01045733
Completed
Not Applicable

A Prospective Contralateral Comparison of Corneal Aberrations in Subjects Undergoing Aspheric Lens Implantation With Concomitant LRI and Aspheric Toric IOL Implantation

Alcon Research1 site in 1 country70 target enrollmentDecember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Alcon Research
Enrollment
70
Locations
1
Primary Endpoint
Corneal Aberration
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The purpose of this study was to evaluate and compare postoperative corneal aberrations and visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular lens (IOL) and AcrySof IQ Aspheric IOL with concomitant limbal relaxing incision.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
May 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Ocular criteria must be met in both eyes.
  • Willing and able to understand and sign an informed consent;
  • Willing and able to attend postoperative examinations per protocol schedule;
  • Have cataracts that require extraction followed by implantation of a posterior chamber intraocular lens and used as an on-label procedure;
  • Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and AcrySof IQ Toric package inserts;
  • Have regular, bowtie shaped corneal astigmatism and qualify for an SN6AT3, SN6AT4 or SN6AT5 Intraocular Lens (IOL) in both eyes;
  • Have the second surgery at least one week following the first eye implant but not later than one month after the first implant.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

  • Previous corneal surgery;
  • Planned multiple procedures during cataract/IOL implantation surgery;
  • Ocular disease and/or condition that may compromise study results;
  • Pregnant or planning pregnancy during course of study;
  • Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Corneal Aberration

Time Frame: Month 6 postoperative

Secondary Outcomes

  • Visual Acuity(Month 6 postoperative)
  • Corneal Cylinder(6 months)

Study Sites (1)

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