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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.)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01074606
First received: February 23, 2010
Last updated: September 18, 2012
Last verified: August 2011
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Uncorrected distance visual acuity (UCDVA) [ Time Frame: Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative ] [ Designated as safety issue: No ]
  • Best corrected distance visual acuity (BDCVA) [ Time Frame: Pre-operative, 1 month postoperative, 3 months postoperative ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074606

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01074606     History of Changes
Other Study ID Numbers: MT-0902
Study First Received: February 23, 2010
Last Updated: September 18, 2012
Health Authority: Taiwan: Institutional Review Board
Taiwan: Department of Health

Keywords provided by Alcon Research:
Cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013