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Published byDortha Butler Modified over 9 years ago
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Change in Patient-Reported Outcomes and Visual Acuity After Bilateral Implantation of Apodized Diffractive +3.0 IOLs Stephen Lane, MD Consultant, Alcon Laboratories, Inc. Alcon sponsored the study and provided statistical and presentation support.
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ASCRS 2010 Methods Purpose To assess changes in patient-reported outcomes (PRO), satisfaction, and visual acuity (VA) after bilateral implantation of the AcrySof® IQ ReSTOR® +3.0 D IOL in cataract patients Prospective, multi-center, 6-month trial Twelve U.S. study centers Subjects ≥21 years of age in need of bilateral cataract surgery Bilateral implantation of IQ ReSTOR ® +3.0 D IOL Cataract TyPE at baseline and 6 months post-operatively Results reported for 147 subjects
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ASCRS 2010 Assessments Binocular Uncorrected Visual Acuities 100% contrast Early Treatment Diabetic Retinopathy Study (ETDRS) chart under photopic lighting Uncorrected Near VA (UCNVA) at 40 cm Uncorrected Intermediate VA (UCIVA) at 60 cm Uncorrected Distance VA (UCDVA) at 4 m Cataract TyPE questionnaire Limitations in distance vision function Limitations in near vision function Limitations in social activities Satisfaction with vision Self rating of vision quality
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ASCRS 2010 Uncorrected Near Visual Acuity Horizontal line across the center of each diamond = group mean. Vertical span of each diamond = 95% confidence intervals around the group mean logMAR Preop6 months p<.0001 20/40 20/20 Statistically significant improvement in Near VA from preop baseline. 20/25 20/32 20/50 20/80 20/60
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ASCRS 2010 Uncorrected Intermediate Visual Acuity p<.0001 logMAR Statistically significant improvement in Intermediate VA from preop baseline. 6 months p<.0001 logMAR Preop 20/20 20/25 20/40 20/32 20/50 20/80 20/60
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ASCRS 2010 Uncorrected Distance Visual Acuity logMAR Preop6 months p<.0001 20/40 20/20 20/25 20/32 20/50 Statistically significant improvement in Distance VA from preop baseline. 20/60
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ASCRS 2010 Limitations in Distance Vision Assessed limitations associated with: usual daily activities, recognizing people or objects across the street, daytime & nighttime driving, reading street or freeway signs, watching television, walking up or down stairs. Statistically significant less limitations in distance vision activities. p<.0001 None Extreme Preop Without Glasses Preop With Glasses 6 months Without Glasses Limitation Scale (0-4)
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ASCRS 2010 Limitations in Near Vision Function Assessed limitations associated with activities such as: reading a magazine, doing crafts or hobbies (sewing, painting), reading labels or prices, depth perception (pouring coffee, hitting a golf ball, or parking a car), and shaving or putting on makeup. Preop Without Glasses Preop With Glasses 6 months Without Glasses Limitation Scale (0-4) p<.0001 None Extreme Statistically significant less limitations in near vision activities.
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ASCRS 2010 Limitations in Social Function Assessed limitations in social activities such as: going out to dinner, going to the movies, visiting with friends or relatives, going to party or dance, going to sporting events or church. Limitation Scale (0-4) Preop Without Glasses Preop With Glasses 6 months Without Glasses None Extreme Statistically significant less patient reported limitations in social activities. p<.0001
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ASCRS 2010 Overall Satisfaction with Vision Preop Without Glasses Preop With Glasses 6 months Without Glasses Satisfaction Scale (0-4) p<.0001 Statistically significant improvement in overall satisfaction from preop baseline. Not Satisfied Completely Satisfied
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ASCRS 2010 Self-rating of vision quality Preop Without Glasses Preop With Glasses 6 months Without Glasses Self-Rating of Vision (0-10) p<.0001 Best Worst Statistically significant higher self-rating of uncorrected vision quality compared with preop baseline.
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ASCRS 2010 Conclusions Statistically significant improvements observed for patients with bilateral AcrySof IQ ReSTOR +3.0 D Add IOL at 6 months compared with preoperative visit : improved near, intermediate, and distance VA less limitations in distance vision activities less limitations in near vision activities less limitations in social activities greater overall satisfaction with vision higher self-rating of vision
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