Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric IOL Implantation Compared to Monofocal IOL Implantation

Study Overview
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Brief Summary
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The objectives of this study are to assess and compare bilateral uncorrected distance visual acuity and distance spectacle independence post bilateral implantation of AcrySof Toric Intraocular Lenses (IOLs) and monofocal IOLs. Secondary outcomes will include cost of eyeglass purchased and patient vision-related quality of life.

Official Title
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Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof Toric Intraocular Lens (IOL) Implantation Compared to Monofocal IOL Implantation

Conditions
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Cataract

Intervention / Treatment
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* Device: Toric T3 - T9
* Device: Monofocal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are willing and able to understand and sign an informed consent; are willing and able to attend postoperative examinations per protocol schedule; are ≥ 21 years of age, of either gender and any race; have bilateral, age related, cataracts; have planned cataract removal via phacoemulsification with implantation of an intraocular lens (IOL); are available to undergo second eye surgery within 6 weeks of the first eye surgery; are in good ocular health, with the exception of cataracts; are free of disease(s)/condition(s) listed in the Precautions section of the AcrySof Toric and monofocal package inserts: choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, extremely shallow anterior chamber, medically uncontrolled glaucoma, microphthalmos, non-age-related cataract, proliferative diabetic retinopathy (severe), severe corneal dystrophy, severe optic nerve atrophy, irregular corneal astigmatism and color vision deficiencies. have regular corneal astigmatism; qualify for bilateral AcrySof Toric IOLs on the AcrySof Toric Calculator (www.acrysoftoriccalculator.com) are able to obtain pupil dilation ≥ 5.0 mm are able to read and understand one of the following languages: Dutch, French, German Exclusion Criteria: previous corneal surgery and/or reshaping abnormality, disease and/or conditions of the cornea (i.e. keratoconus, corneal dystrophy, keratitis, corneal scar, etc.), which would clinically contra-indicate the implantation of a toric intraocular lens planned multiple procedures during cataract/IOL implantation surgery planned limbal relaxing incision (LRI), Excimer laser treatment or similar procedure prior to or during the course of the study an ocular disease and/or condition that may compromise visual acuity levels (i.e. glaucoma, diabetic retinopathy, amblyopia, etc.) pregnant, lactating or planning pregnancy during course of study. Subjects who become pregnant during the study will not be discontinued; however, data may be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results. Data will be collected on the CRF as observations.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toric T3 - T9<br>Bilateral implantation of a Toric intraocular lens (IOL) models T3, T4, T5, T6, T7, T8 or T9 | Device: Toric T3 - T9<br>* Bilateral implantation of Alcon AcrySof Toric Intraocular Lens (IOL) models SN60T3 through SN60T9 following cataract removal.<br>|
| Active Comparator: Monofocal<br>Bilateral implantation of a monofocal intraocular lens (IOL) model with no toric component. | Device: Monofocal<br>* Bilateral implantation of any monofocal Intraocular Lens (IOL) following cataract removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Distance Visual Acuity | Visual Acuity (VA) is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity. | 6 Months After Surgery | 
| Spectacle Independence | Spectacle Independence (the ability of the patient to go without corrective lenses) measured by a subjective patient questionnaire. | 6 Months After Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vision-related Quality of Life | Vision related quality of life as measured by a subjective subject questionnaire. | 6 Months After Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraocular lens, Toric