Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses
Condition: Cataract
MeSH terms: Cataract
Intervention: Crystalens AO; SoftPort LI61AO
Intervention description: Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the Crystalens AO intraocular lens.; Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the SoftPort LI61AO intraocular lens.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: cataract surgery; intraocular lens

Summary:

      The objective of this study is to demonstrate the correlation of near vision and changes in
      higher order aberrations following lens extraction and to characterize the defocus curves of
      Crystalens® AO™ intraocular lens (IOL) versus the monofocal aspheric SofPort® LI61AO IOL in
      adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have clear intraocular media other than cataract.

          -  Subjects must have a clinically documented diagnosis of age-related bilateral
             cataracts that are considered amenable to treatment with standard phacoemulsification
             cataract extraction.

          -  Subjects must be undergoing primary IOL implantation for the correction of aphakia
             following central continuous curvilinear anterior capsulorrhexis and
             phacoemulsification cataract extraction.

          -  Subjects must require a spherical lens power from 10.00 D to 30.00 D.

          -  Subjects must be willing and able to return for all scheduled follow-up examinations
             for each eye from days 1 through 180 following surgery.

          -  Subjects must have ≤ 1.25 D of preoperative corneal astigmatism.

        Exclusion Criteria:

          -  Subjects with corneal pathology potentially affecting topography.

          -  Subjects whose fundus cannot be assessed preoperatively.

          -  Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or
             other retinal disorders) that cause potential acuity losses to a level worse than
             20/30 as verified by OCT.

          -  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
             non-proliferative) which reduces potential acuity to 20/30 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 worse than 20/30.

          -  Subjects with optic atrophy.

          -  Subjects with iris neovascularization.

          -  Subjects with clinically significant retinal pigment epithelium/macular changes which
             reduces potential acuity to 20/30 or worse.

          -  Subjects with chronic use of systemic steroids or immunosuppressive medications.

          -  Subjects lacking intact binocular vision.