Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00760487
Recruitment Status : Completed
First Posted : September 26, 2008
Results First Posted : April 7, 2010
Last Update Posted : January 16, 2012
Information provided by:
Alcon Research

Brief Summary:
The purpose of this study is to evaluate the effect that placement and power of the AcrySof Toric has on post-operative visual acuity and spectacle independence for distance vision. This will be determined by comparing manifest refraction pre-operatively and post-operatively and by evaluating the rotational stability of the lens over time.

Condition or disease Intervention/treatment Phase
Cataract Device: AcrySof Toric IOL Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2006
Actual Primary Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AcrySof Toric IOL
AcrySof Toric Intraocular Lens (IOL)
Device: AcrySof Toric IOL
Implantation with the AcrySof Toric IOL for cataract replacement and multiple follow-up assessments

Primary Outcome Measures :
  1. Visual Acuity (VA) [ Time Frame: Pre-operative, 1 month, 3 month, and 6 month post-operative ]
    Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).

Secondary Outcome Measures :
  1. Spectacle Independence [ Time Frame: 6 months post-operative ]
    Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit

  2. IOL Rotation [ Time Frame: 6 months post-operative ]
    Evaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Are a candidate for bilateral implantation
  • In good general and ocular health, 21 years of age or older, of either gender or any race, diagnosed with age-related cataracts in both eyes
  • In need of spherical correction between 10.0 Diopter (D) and 30.0 D
  • Preoperative regular corneal astigmatism, ≥ 1.0 D and ≤ 2.5 D , as measured by keratometry
  • Willing and able to complete all required postoperative visits
  • Able to comprehend and sign a statement of informed consent
  • Pupil dilation ≥ 6.0 mm
  • Expected to achieve a postoperative logMAR +0.3 or better visual acuity (as assessed by one or more of the following: fundus examination, pinhole visual acuity, and/or PAM evaluation);

Exclusion Criteria:

Exclusion Criteria Before Surgery - Ocular

  • Previous cataract patient without potential of bilateral implantation
  • Females of child bearing potential
  • Irregular corneal astigmatism
  • Keratopathy/Keratectasia - any corneal abnormality including but not limited to the following: keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and cornea plana
  • Any inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis
  • Previous corneal reshaping, including but not limited to the following: keratomileusis, radial keratotomy (RK), photorefractive keratectomy (PRK), Laser in Situ Keratomileusis (LASIK), Thermal Keratoplasty (TK), and Penetrating Keratoplasty (PK)
  • Clinically significant corneal dystrophy (including Fuch's dystrophy)
  • Previous corneal transplant
  • Amblyopia
  • Glaucoma (medically uncontrolled)
  • Clinically significant RPE/Macular changes
  • Proliferative diabetic retinopathy
  • History of macular edema
  • Previous history of retinal detachment
  • History of uveitis/iritis
  • Extremely shallow anterior chamber, not due to swollen cataract
  • Iris neovascularization
  • Microphthalmos
  • Absent eye or eye with no light perception (NLP) as fellow eye
  • Rubella, congenital, traumatic, or complicated cataract
  • Optic atrophy

Exclusion Criteria During Surgery

  • Other procedures at this surgery
  • Limbal relaxing incisions (LRIs) or any other procedure to reduce the amount of preoperative astigmatism on the study eye(s), whether implanted with SA60TT or SA60AT, for the duration of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00760487

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

Responsible Party: Ms Myrna Bergen, Phase IV Clinical Research Manager, Alcon Canada Inc. Identifier: NCT00760487     History of Changes
Other Study ID Numbers: ALCONsurtor001.06
First Posted: September 26, 2008    Key Record Dates
Results First Posted: April 7, 2010
Last Update Posted: January 16, 2012
Last Verified: January 2012

Keywords provided by Alcon Research:
Cataract AcrySof Toric IOL
Bilateral cataract

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases