Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens
Condition: Cataract
MeSH terms: Cataract
Intervention: AcrySof Toric IOL
Intervention description: Implantation with the AcrySof Toric IOL for cataract replacement and multiple follow-up assessments
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Cataract AcrySof Toric IOL; Bilateral cataract

Summary:

      The purpose of this study is to evaluate the effect that placement and power of the AcrySof
      Toric has on post-operative visual acuity and spectacle independence for distance vision.
      This will be determined by comparing manifest refraction pre-operatively and post-operatively
      and by evaluating the rotational stability of the lens over time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are a candidate for bilateral implantation

          -  In good general and ocular health, 21 years of age or older, of either gender or any
             race, diagnosed with age-related cataracts in both eyes

          -  In need of spherical correction between 10.0 Diopter (D) and 30.0 D

          -  Preoperative regular corneal astigmatism, ≥ 1.0 D and ≤ 2.5 D , as measured by
             keratometry

          -  Willing and able to complete all required postoperative visits

          -  Able to comprehend and sign a statement of informed consent

          -  Pupil dilation ≥ 6.0 mm

          -  Expected to achieve a postoperative logMAR +0.3 or better visual acuity (as assessed
             by one or more of the following: fundus examination, pinhole visual acuity, and/or PAM
             evaluation);

        Exclusion Criteria:

        Exclusion Criteria Before Surgery - Ocular

          -  Previous cataract patient without potential of bilateral implantation

          -  Females of child bearing potential

          -  Irregular corneal astigmatism

          -  Keratopathy/Keratectasia - any corneal abnormality including but not limited to the
             following: keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and
             cornea plana

          -  Any inflammation or edema (swelling) of the cornea, including but not limited to the
             following: keratitis, keratoconjunctivitis, and keratouveitis

          -  Previous corneal reshaping, including but not limited to the following:
             keratomileusis, radial keratotomy (RK), photorefractive keratectomy (PRK), Laser in
             Situ Keratomileusis (LASIK), Thermal Keratoplasty (TK), and Penetrating Keratoplasty
             (PK)

          -  Clinically significant corneal dystrophy (including Fuch's dystrophy)

          -  Previous corneal transplant

          -  Amblyopia

          -  Glaucoma (medically uncontrolled)

          -  Clinically significant RPE/Macular changes

          -  Proliferative diabetic retinopathy

          -  History of macular edema

          -  Previous history of retinal detachment

          -  History of uveitis/iritis

          -  Extremely shallow anterior chamber, not due to swollen cataract

          -  Iris neovascularization

          -  Microphthalmos

          -  Absent eye or eye with no light perception (NLP) as fellow eye

          -  Rubella, congenital, traumatic, or complicated cataract

          -  Optic atrophy

        Exclusion Criteria During Surgery

          -  Other procedures at this surgery

          -  Limbal relaxing incisions (LRIs) or any other procedure to reduce the amount of
             preoperative astigmatism on the study eye(s), whether implanted with SA60TT or SA60AT,
             for the duration of the study