VISION WITH RESTOR® , ARRAY® SA40 AND A MONOFOCAL INTRA-OCULAR LENS (IOL) AFTER CATARACT SURGERY
Author(s)
Gilles Berdeaux, MD, Associate Director1, Niels De vries, MD, Docteur2, Antoine Lafuma, MD, Director3, Caroline Laurendeau, MSc, Project manager4, Rudy Nuijts, MD, PhD, Professor21Alcon France, Rueil-Malmaison, France; 2 University Hospital Maastricht, Maastricht, Netherlands; 3 Cemka eval, Bourg-la-Reine, France; 4 Cemka-Eval, Bourg-la-Reine, France
OBJECTIVES: The aim of this study was to compare vision 6 months after cataract surgery in patients implanted with one of three IOLs: a monofocal or a multifocal (ReSTOR® or ARRAY-SA40®). The latter two often free patients from spectacles for near and distance vision. METHODS: A randomized clinical trial comparing ARRAY-SA40® with a monofocal was pooled with a prospective cohort of patients implanted with ReSTOR®. Patient satisfaction, spectacle freedom rate, and corrected and uncorrected, near and distance visual acuities (VA) were measured six months after surgery. Treatment group comparability was checked at baseline. Imbalances on confounding factors were adjusted using both linear models and propensity scores. RESULTS: Sixtry-nine patients had a monofocal, 68 received the ARRAY-SA40® and 83 were implanted with ReSTOR®. ReSTOR® patients were younger (P<0.0001) and had a lower neuroticism score (P<0.001). The sex-ratio was six females: four males. VA and spectacle dependency at baseline were comparable. At 6 months no difference was observed on distance VA, corrected or uncorrected. Uncorrected near VA of ReSTOR® patients was better (P<0.0001) than with either a monofocal IOL or ARRAY-SA40®. The probability of being free of spectacles with ReSTOR was higher (P<0.0001) than with a monofocal (RR=10.2) or an ARRAY-SA40® (RR=10.7). ReSTOR® patients wearing spectacles never had multifocal glasses (the most expensive), while 32% of ARRAY-SA40® and 52% of the monofocal patients did. Good or excellent near vision satisfaction with ReSTOR® was more often reported by patients than with the ARRAY-SA40® or a monofocal (83.6%, 32.4%, 26.1%, respectively; P<0.0001). The corresponding satisfaction difference did not reach statistical significance with distance vision (82.1%, 75.0%, 67.7%, respectively; P<0.17). Linear and propensity score adjustments did not modify the results. CONCLUSIONS: The uncorrected distance VA of the three IOLs was similar. Near uncorrected VA in ReSTOR® patients was better than in patients implanted with a monofocal or ARRAY-SA40®, resulting in a higher spectacle independence rate and better near vision patient satisfaction
Conference/Value in Health Info
2008-11, ISPOR Europe 2008, Athens, Greece
Value in Health, Vol. 11, No. 6 (November 2008)
Code
PSS3
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Sensory System Disorders