Clinical Evaluation of a 1-Piece Intraocular Lens
Condition: Cataract
MeSH terms: Cataract
Intervention: Tecnis ZCB00 IOL (control); Toric Intraocular lens
Intervention description: Tecnis 1-piece acrylic IOL; Toric acrylic intraocular lens with various cylinder powers
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 269.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cataract, Intraocular lens

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
    

Eligibility criteria:

        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