Visual Function After Bilateral Implantation of AcrySof® Toric

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00758550
First received: September 23, 2008
Last updated: March 4, 2010
Last verified: March 2010

September 23, 2008
March 4, 2010
April 2007
June 2008   (final data collection date for primary outcome measure)
Uncorrected Visual Acuity (UCVA) [ Time Frame: 6 Months after surgery ] [ Designated as safety issue: Yes ]
Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
uncorrected and best distance corrected visual acuities (UCVA and BDCVA) [ Time Frame: Before surgery;1 Day,1 Month,3 Months and 6 Months after surgery ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00758550 on ClinicalTrials.gov Archive Site
Questionnaire Results [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).
Orientation of Toric IOL [ Time Frame: 1 Day,1 Month,3 Months and 6 Months after surgery ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Visual Function After Bilateral Implantation of AcrySof® Toric
Visual Function After Bilateral Implantation of AcrySof® Toric

The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Visual Function
  • Device: AcrySof® Toric IOL
    AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery
  • Device: AcrySof Natural
    AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery
  • Experimental: AcrySof Toric IOL
    AcrySof Toric Intraocular Lens (IOL)
    Intervention: Device: AcrySof® Toric IOL
  • Active Comparator: AcrySof Natural IOL
    AcrySof Natural Intraocular Lens (IOL)
    Intervention: Device: AcrySof Natural
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Bilateral cataracts
  • 40~80 years of age
  • 4 Days - 1 Week interval between a single patient's surgery
  • dilated pupil size (in dim light) ≥ 4.0 mm
  • Anticipated correction with an IOL of +10 Diopters ~ +25 Diopters
  • 0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings

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(within 6 months prior to first surgery)
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00758550
CM-06-17
No
Benny Li, Scientific Clinical Affairs Manager, Alcon Research Ltd.
Alcon Research
Not Provided
Not Provided
Alcon Research
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP