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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00760487
First received: September 25, 2008
Last updated: January 12, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Cataract
 Device: AcrySof Toric IOL
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Visual Acuity (VA) [ Time Frame: Pre-operative, 1 month, 3 month, and 6 month post-operative ] [ Designated as safety issue: Yes ]
    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:
  • Spectacle Independence [ Time Frame: 6 months post-operative ] [ Designated as safety issue: Yes ]
    Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit

  • IOL Rotation [ Time Frame: 6 months post-operative ] [ Designated as safety issue: No ]
    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.


Enrollment: 120
Study Start Date: October 2006
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
Implantation with the AcrySof Toric IOL for cataract replacement and multiple follow-up assessments

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760487

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: Ms Myrna Bergen, Phase IV Clinical Research Manager, Alcon Canada Inc.
ClinicalTrials.gov Identifier: NCT00760487     History of Changes
Other Study ID Numbers: ALCONsurtor001.06
Study First Received: September 25, 2008
Results First Received: September 22, 2009
Last Updated: January 12, 2012
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013