Clinical Investigation of Expanded Designs of a Multifocal IOL
Condition: Cataract
MeSH terms: Cataract
Intervention: Tecnis Multifocal Intraocular Lens; Monofocal Intraocular Lens
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 445.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cataract; IOL; intraocular lens

Summary:

      The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS
      Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide
      statistically better distance-corrected near visual acuity compared to the monofocal control
      lens. Complication and adverse event rates associated with each Multifocal IOL will be within
      the ISO SPE rate for posterior chamber IOLs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Minimum 18 years of age

          -  Bilateral cataracts for which phacoemulsification extraction and posterior IOL
             implantation have been planned for both eyes

          -  Preoperative best-corrected distance visual acuity (BCDVA) of 20/40 or worse (Snellen)
             with or without a glare source

          -  Potential for postoperative best-corrected visual acuity of 20/25 or better

          -  Preoperative corneal astigmatism of 1.0 D or less with normal corneal topography and
             no irregular corneal astigmatism

          -  Clear intraocular media, other than cataract

          -  Availability, willingness and sufficient cognitive awareness to comply with
             examination procedures

          -  Signed informed consent and HIPAA authorization or equivalent documentation necessary
             to comply with applicable privacy laws pertaining to medical treatment in the
             governing countries

          -  Ability to understand and respond to a questionnaire verbally administered in English

        Exclusion Criteria:

          -  Requiring an intraocular lens power outside the available range of +16.0 to +28.0 D

          -  Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)

          -  Recent ocular trauma or ocular surgery that is not resolved/stable or may affect
             visual outcomes

          -  Prior refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery

          -  Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are
             predicted to cause visual acuity losses to a level of 20/30 or worse during the study

          -  Inability to achieve keratometric stability for contact lens wearers

          -  Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or
             other retinal disorders) that are predicted to cause visual acuity losses to a level
             of 20/30 or worse during the study

          -  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

          -  Use of systemic or ocular medications that may affect vision

          -  Prior, current, or anticipated use during the course of the 12-month study of
             tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) likely, in the opinion
             of the investigator, to cause poor dilation or lack of adequate iris structure to
             perform standard cataract surgery

          -  Inability to focus, fixate or maintain binocular vision for prolonged periods of time
             (e.g., due to strabismus, nystagmus, etc.)

          -  Poorly-controlled diabetes

          -  Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the
             opinion of the investigator, would increase the operative risk or confound the
             outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected
             glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation,
             etc.). Note: ocular hypertension without glaucomatous changes is acceptable.

          -  Known ocular disease or pathology that may affect visual acuity or that may be
             expected to require retinal laser treatment or other 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 within 30 days prior to preoperative visit
             in any other clinical trial

          -  Desire for monovision correction