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Rotational Stability of the AcrySof® Toric

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00762216
First received: September 26, 2008
Last updated: October 26, 2012
Last verified: May 2010
History of Changes
  Purpose

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: Open Label
Primary Purpose: Treatment
Official Title: Rotational Stability of the AcrySof® Toric

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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
Toric
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00762216

Locations
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
ClinicalTrials.gov 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:
Cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013