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Clinical Evaluation of a 1-Piece 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.
ClinicalTrials.gov Identifier: NCT01098812
Recruitment Status : Completed
First Posted : April 5, 2010
Results First Posted : July 2, 2013
Last Update Posted : July 2, 2013
Information provided by (Responsible Party):
Abbott Medical Optics

Brief Summary:

The aims of this study are to:

  • Demonstrate a reduction in postoperative cylinder compared to results from the control lens
  • Demonstrate better uncorrected distance visual acuity compared to the control lens

Condition or disease Intervention/treatment Phase
Cataract Device: Tecnis ZCB00 IOL (control) Device: Toric Intraocular lens Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the TECNIS® Toric 1-Piece Intraocular Lens
Study Start Date : March 2010
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Control IOL
Approved Intraocular control lens
Device: Tecnis ZCB00 IOL (control)
Tecnis 1-piece acrylic IOL
Experimental: Toric IOL
Investigational Toric IOL
Device: Toric Intraocular lens
Toric acrylic intraocular lens with various cylinder powers
Experimental: Higher Cylinder Toric IOL
Investigational Toric IOLs with higher cylinder powers.
Device: Toric Intraocular lens
Toric acrylic intraocular lens with various cylinder powers

Primary Outcome Measures :
  1. Mean Percent Reduction in Cylinder [ Time Frame: 6 months after second eye implant compared to baseline ]
    Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean.

Secondary Outcome Measures :
  1. Uncorrected Distance Visual Acuity (UCDVA) [ Time Frame: 6 months after second eye implant ]
    Postoperative uncorrected distance visual acuity as measured by LogMAR acuity. For comparison: LogMAR value of 0.0 = Snellen 20/20; LogMar 0.10 = Snellen 20/25; LogMAR 0.20 = Snellen 20/32; LogMAR 0.30 = Snellen 20/40. Uncorrected distance visual acuity as measured by LogMAR acuity was assessed in the first eye (per participant) for contribution to the mean.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Minimum 18 years of age
  • Cataract for which phacoemulsification extraction and posterior chamber IOL implantation has been planned for both eyes
  • Preoperative best corrected distance visual acuity (BCDVA)of 20/40 or worse (Snellen), with or without glare, for each eye
  • BCDVA projected to be better than 20/30 following cataract removal and IOL implantation for each eye
  • Preoperative keratometric cylinder of 0.75 diopters to 3.62 diopters for each eye (with exception of second eyes with 0.0-0.75 diopters planned to receive non-toric IOL)
  • Clear intraocular media other than cataract in both eyes
  • Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
  • Signed informed consent and HIPAA authorization

Exclusion Criteria:

  • Requiring IOLs outside spherical power range of +15.0 to +28.0 diopters
  • Dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)in either eye
  • Previous corneal or intraocular surgery in either eye
  • Irregular corneal astigmatism in either eye
  • Corneal pathology/abnormality potentially affecting topography in either eye
  • Corneal abnormalities such as stromal, epithelial or endothelial dystrophies in either eye
  • Inability to achieve keratometric stability in either eye for contact lens wearers
  • Subjects with diagnosed degenerative visual disorders in either eye(eg., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
  • Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
  • An eccentric anterior capsulorhexis, zonular damage/rupture or capsular tear/rupture during the cataract extraction procedure
  • Use of systemic or ocular medications that may affect vision
  • Prior, current, or anticipated use during the course of the nine month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo)likely to affect dilation or iris structure
  • Poorly-controlled diabetes
  • Acute, chronic, or uncontrolled systemic disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.)
  • Uncontrolled ocular hypertension or glaucomatous changes in the retina or visual field in either eye
  • Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
  • Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
  • Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical trial

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 ClinicalTrials.gov identifier (NCT number): NCT01098812

United States, California
AMO Clinical Research Call Center for Trial Locations
Santa Ana, California, United States, 92705
Sponsors and Collaborators
Abbott Medical Optics
Study Director: Nicholas Tarantino, O.D. Abbott Medical Optics

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01098812     History of Changes
Other Study ID Numbers: TIOL-103-TCNS
First Posted: April 5, 2010    Key Record Dates
Results First Posted: July 2, 2013
Last Update Posted: July 2, 2013
Last Verified: June 2013

Keywords provided by Abbott Medical Optics:
Cataract, Intraocular lens

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases