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.
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
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
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< /40 20/20 Statistically significant improvement in Near VA from preop baseline. 20/25 20/32 20/50 20/80 20/60
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
ASCRS 2010 Uncorrected Distance Visual Acuity logMAR Preop6 months p< /40 20/20 20/25 20/32 20/50 Statistically significant improvement in Distance VA from preop baseline. 20/60
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)
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.
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
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
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.
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