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Visual Function After Implantation of AcrySof® Toric Lens

This study has been terminated.
(The study was terminated based on a business decision.)
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: February 23, 2010
Last updated: September 18, 2012
Last verified: August 2011
The objective of this study is to evaluate the postoperative visual function of Taiwanese patients following bilateral or unilateral AcrySof Toric Intraocular Lens (IOL) implantation.

Condition Intervention Phase
Cataract Device: AcrySof Toric Intraocular Lens Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Postoperative Refractive Cylinder [ Time Frame: Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative ]

Secondary Outcome Measures:
  • Uncorrected distance visual acuity (UCDVA) [ Time Frame: Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative ]
  • Best corrected distance visual acuity (BDCVA) [ Time Frame: Pre-operative, 1 month postoperative, 3 months postoperative ]

Enrollment: 56
Study Start Date: January 2010
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Toric
AcrySof Toric Intraocular Lens (IOL)
Device: AcrySof Toric Intraocular Lens
Implantation of the AcrySof Toric Intraocular Lens (IOL)


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Prospective subjects should be adults and may be of any race and gender, and diagnosed with cataracts.
  • Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens.
  • All subjects must have between 0.75 - 2.0 Diopter (D) of astigmatism preoperatively as measured by keratometry readings.
  • For any second eye surgery in bilateral AcrySof Toric patients, it should be performed at least one week following the first eye implant but no longer than one month after the first implant.

Exclusion Criteria:

  • Subjects with pre-existing conditions that could skew the results should be excluded from the Study.
  • AcrySof® Toric product inserts under "Precautions" for subject groups that should be excluded from this Study.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01074606

Changhua City, Taiwan, 500
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon Research Identifier: NCT01074606     History of Changes
Other Study ID Numbers: MT-0902
Study First Received: February 23, 2010
Last Updated: September 18, 2012

Keywords provided by Alcon Research:

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases processed this record on August 18, 2017