Text Size

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
History of Changes
  Purpose

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.


Condition Intervention Phase
Visual Function
 Device: AcrySof® Toric IOL
Device: AcrySof Natural
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Visual Function After Bilateral Implantation of 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:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 60
Study Start Date: April 2007
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AcrySof Toric IOL
AcrySof Toric Intraocular Lens (IOL)
 Device: AcrySof® Toric IOL
AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery
Active Comparator: AcrySof Natural IOL
AcrySof Natural Intraocular Lens (IOL)
 Device: AcrySof Natural
AcrySof Natural Intraocular Lens (IOL) implanted into the study 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:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758550

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: Benny Li, Scientific Clinical Affairs Manager, Alcon Research Ltd.
ClinicalTrials.gov Identifier: NCT00758550     History of Changes
Other Study ID Numbers: CM-06-17
Study First Received: September 23, 2008
Results First Received: August 13, 2009
Last Updated: March 4, 2010
Health Authority: China: Ethics Committee

Keywords provided by Alcon Research:
Visual function;
Refractive cylinder;
AcrySof® Toric;
AcrySof® Natural

ClinicalTrials.gov processed this record on May 19, 2013