VISION BENEFIT FROM MULTI-FOCAL INTRAOCULAR LENS (IOL) AFTER CATARACT SURGERY ESTIMATED BY PRINCIPAL COMPONENTS ANALYSIS

Author(s)

Gilles Berdeaux, MD, Associate Director1, Muriel Viala, MSc, Senior Research Analyst2, Benoit Arnould, MSc, MA, Director, Patient Scales for Clinical Practice21Alcon France, Rueil-Malmaison, France; 2 Mapi Values France, Lyon, France

OBJECTIVE: Restoration of near and far vision function without recourse to spectacles remains a major goal of cataract surgery. ReSTOR®, a new multi-focal IOL, addresses this issue by improving both near and far vision without spectacles. The present analysis attempts to quantify the vision benefits experienced by patients. METHODS: Data from two clinical trials conducted in Europe and the United States, evaluating the safety and efficacy of ReSTOR® compared to a mono-focal IOL (MoF), were pooled for an analysis of 672 patients undergoing cataract extraction. The TyPE questionnaire was administered at baseline, and after both first-eye and second-eye surgery. The TyPE measures 67 items evaluating distance and near vision limitations, social activities, glare and halo problems, and patient satisfaction both with and without spectacles. Principal components analyses (PCA) of the TyPE questionnaire were performed at baseline, and after first-eye and second-eye surgery. Factorial coordinates were compared both between ReSTOR® and MoF (t-tests), and between visits (paired t-tests). RESULTS: The first PCA factor (F1) concerned limitations to overall visual function. The second factor (F2) concerned vision limitations without spectacles. Overall, significant improvements of visual function were seen between baseline and first-eye surgery (p<0.0001), and between first-eye and second-eye surgery (p<0.0001). At baseline, no significant differences were observed between treatment groups with respect to F1 or F2. Vision after first-eye surgery was significantly better in the ReSTOR® group than the MoF group on both factors (F1: p<0.006; F2: p<0.001). These differences between ReSTOR® and MoF were maintained and reinforced after second-eye surgery (F1: p<0.001; F2: p<0.001). CONCLUSIONS: Mono-focal and ReSTOR® IOLs both improved visual function, but only ReSTOR® improved the “vision without spectacles” factor because, of course, the monofocal does not correct near vision.

Conference/Value in Health Info

2006-10, ISPOR Europe 2006, Copenhagen, Denmark

Value in Health, Vol. 9, No.6 (November/December 2006)

Code

PEY26

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Sensory System Disorders

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