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Acrysof Toric SN60T3corneal Astigmatism Between 0.75 and 1.00 D. (TORILIOL)

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: NCT00542581
Recruitment Status : Completed
First Posted : October 11, 2007
Last Update Posted : July 24, 2018
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:

The purpose of this study is to evaluate the visual outcomes and patient satisfaction after implantation of a toric IOL in patients with predicted residual corneal astigmatism between 0.75 and 1.00 D.

Cataract is prevalent throughout the world and IOLs are routinely implanted after the extraction of the cataractous lens. It is the most frequently performed surgery in the United States with an estimated 2-3 million procedures performed annually. With the aging population on the rise, as well as the increasing popularity of refractive intraocular lenses, the number of intraocular surgeries continues to rise. Over the years, the surgical technique has evolved from intracapsular extraction to modern phacoemulsification. This development has helped with the evolution of IOLs as well. The IOLs have advanced extensively: different materials and designs are available, permitting implantation through smaller, sutureless incisions. Traditional IOLs are of monofocal design providing vision at one distance, typically far; and correct mainly the spherical component of the refractive error. However, there are patients with corneal astigmatism that require additional surgical treatment such as laser correction (laser in situ leratomileusis, LASIK; photorefractive keratectomy, PRK) or limbal relaxing incisions, RLI). Another alternative is the use of a toric IOL, which has been especially designed to correct both the sphere and the astigmatism. The ACRYSOF Toric IOL is intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and preexisting comeal astigmatism in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision.

The treatment selection of the corneal astigmatism depends on the amount of cylinder as follows, between 0.25 and 0.75 D creating the surgical incision on the steep axis; between 0.75 and 1.75 D, RLI; between 1 and 2.25 D, toric IOLs; and between 1 and 3.00 D, LASIK/PRK.

Condition or disease Intervention/treatment Phase
Cataracts Device: The Acrysof toric SN60T3 IOL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Evaluation of the Acrysof Toric SN60T3 Intraocular Lens in Patients With Predicted Residual Corneal Astigmatism Between 0.75 and 1.00 D.
Study Start Date : October 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: The Acrysof toric SN60T3 IOL
Multifocal Intraocular Lens
Device: The Acrysof toric SN60T3 IOL
Intraocular Lens

Primary Outcome Measures :
  1. The primary benefit from implantation of an IOL and participation in this study is the restoration of useful vision following removal of the cataracts. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

Subjects MUST fulfill the following conditions to qualify for enrollment into the trial

  • Subject must have an age-related cataract in both eyes.
  • 21 years of age or older.
  • Patient must desire cataract extraction.
  • Expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries.
  • Cross-cylinder value calculation from the Toric Calculator indicates a cross-cylinder correction from 0.75D to 1.0D in at least one eye and up to 1.75 in the fellow eye.
  • Willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.

  • Preoperative ocular pathology:

    • Amblyopia
    • Rubella cataract
    • Proliferative diabetic retinopathy
    • Shallow anterior chamber
    • Macular edema
    • Retinal detachment
    • Aniridia or iris atrophy
    • Uveitis
    • History of iritis
    • Iris neovascularization
    • Medically uncontrolled glaucoma
    • Microphthalmus or macrophthalmus
    • Optic nerve atrophy
    • Macular degeneration (with anticipated best postoperative visual acuity less than 20/30)
    • Advanced glaucomatous damage, etc.
  • Planned postoperative refraction for mono-vision.
  • Uncontrolled diabetes.
  • Use of any systemic or topical drug known to interfere with visual performance.
  • Contact lens use during the active treatment portion of the trial.
  • Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
  • Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
  • Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
  • Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
  • Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
  • Other ocular surgery at the time of the cataract extraction.

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): NCT00542581

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United States, South Carolina
Medical Unvirsity of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
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Principal Investigator: Kerry D. Solomon, MD Storm Eye Institute
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Responsible Party: Medical University of South Carolina Identifier: NCT00542581    
Other Study ID Numbers: SEI 07-001
First Posted: October 11, 2007    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: October 2010
Keywords provided by Medical University of South Carolina:
Visual Outcomes
Patient Satisfaction
Cataractous Lens
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases
Refractive Errors