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
Device: AcrySof® Toric intraocular lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: India: Institutional Review Board

Keywords provided by Alcon Research:

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases processed this record on April 15, 2014