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Rotational Stability of the AcrySof® Toric

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: September 26, 2008
Last updated: October 26, 2012
Last verified: May 2010
To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.

Condition Intervention
Cataract Device: AcrySof® Toric intraocular lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rotational Stability of the AcrySof® Toric

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Rotational Stability [ Time Frame: 6 Months post-surgery ]
    Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.

Secondary Outcome Measures:
  • Residual Refractive Cylinder [ Time Frame: 6 Months post-surgery ]
    The refractive astigmatism 6 months post-surgery, measured in diopters.

Enrollment: 71
Study Start Date: May 2008
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Implantation with the AcrySof® Toric intraocular lens
Device: AcrySof® Toric intraocular lens
Implantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Monolateral or bilateral cataracts
  • anticipated intraocular lens (IOL) power of +10 Diopters (D) ~ +25D
  • 0.75 ~ 2.0 D of astigmatism measured preoperatively by Keratometry readings
  • able to sign the informed consent, to comply with scheduled visits and other study procedures

Exclusion Criteria:

  • Preoperative ocular pathology
  • previous intraocular or corneal surgery
  • an increased risk for complications which could require vitreoretinal surgery
  • corneal irregularities
  • corneal opacities
  • current contact lens usage
  • uncontrolled diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00762216

United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon Research Identifier: NCT00762216     History of Changes
Other Study ID Numbers: RM-08-001
Study First Received: September 26, 2008
Results First Received: April 14, 2010
Last Updated: October 26, 2012

Keywords provided by Alcon Research:

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases processed this record on August 22, 2017