Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction
Condition: Cataract
MeSH terms: Cataract; Myopia
Intervention: Crystalens AO; ReSTOR 3.0; AMO Tecnis Multifocal
Intervention description: Bausch & Lomb model silicone multi-piece accommodating IOL.; An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.; The Tecnis Multifocal foldable hydrophobic acrylic IOL, Model ZMA00 (Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 93.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: phacoemulsification; intraocular lens

Summary:

      The objective of this study is to compare the contrast sensitivity, high and low contrast
      visual acuity (VA), glare meter outcomes, and subject satisfaction with three different
      FDA-approved intraocular lenses (IOLs) designed to improve distance, intermediate, and near
      vision following lens extraction in adults at least 40 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be undergoing primary IOL implantation for the correction of aphakia
             following continuous curvilinear anterior capsulotomy and phacoemulsification cataract
             extraction.

          -  Subjects must require a spherical lens power from 10.00 diopters (D) to 33.00 D.

          -  Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32
             or better in both eyes.

          -  Subjects must have stopped contact lens wear for at least two weeks for soft lens
             wearers or three weeks for gas permeable lens wearers prior to biometry and surgery.

          -  At the time of surgery, subjects must have an intact centered capsulorhexis, intact
             posterior capsule, and no zonular rupture.

          -  Subjects must have ≤ 1.25 D of preoperative corneal astigmatism in both eyes.

        Exclusion Criteria:

          -  Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or
             other retinal disorders) that cause potential acuity losses to a level of 20/32 or
             worse.

          -  Subjects with conditions with increased risk of zonular rupture, such as
             pseudoexfoliation syndrome.

          -  Subjects who have any active inflammation or edema (swelling) of the cornea, including
             but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.

          -  Subjects with uncontrolled glaucoma.

          -  Subjects with previous retinal detachment.

          -  Subjects with visually significant diabetic retinopathy (proliferative or
             nonproliferative) which reduces potential acuity to 20/32 or worse.

          -  Subjects with rubella, bilateral congenital, traumatic, complicated or polar cataract.

          -  Subjects with marked microphthalmos or aniridia.

          -  Subjects who have had previous corneal surgery.

          -  Subjects with irregular corneal astigmatism.

          -  Subjects with amblyopia which reduces potential acuity to 20/32 or worse.

          -  Subjects with optic atrophy.

          -  Subjects with iris neovascularization.

          -  Subjects with clinically significant retinal pigment epithelium/macular changes which
             reduces potential acuity to 20/32 or worse.

          -  Subjects with chronic use of systemic steroids or immunosuppressive medications.