Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens

Study Overview
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Brief Summary
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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.

Conditions
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Cataract

Intervention / Treatment
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* Device: AcrySof Toric IOL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AcrySof Toric IOL<br>AcrySof Toric Intraocular Lens (IOL) | Device: AcrySof Toric IOL<br>* Implantation with the AcrySof Toric IOL for cataract replacement and multiple follow-up assessments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity (VA) | Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. It is a unit of measure for visual acuity (VA). | Pre-operative, 1 month, 3 month, and 6 month post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spectacle Independence | Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit | 6 months post-operative | 
| IOL Rotation | Evaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation. | 6 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract AcrySof Toric IOL, Bilateral cataract