Patient-reported benefit of ReSTOR<sup>® </sup>multi-focal intraocular lenses after cataract surgery: Results of Principal Component Analysis on clinical trial data

<p>Abstract</p> <p>Background</p> <p>Restoration of functional distance and near vision independently of additional correction remains a goal for cataract surgery. ReSTOR<sup>®</sup>, a new multi-focal intraocular lens (IOL) addresses this issue with an impr...

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Main Authors: Viala Muriel, Berdeaux Gilles, Roborel de Climens Aude, Arnould Benoit
Format: Article
Language:English
Published: BMC 2008-01-01
Series:Health and Quality of Life Outcomes
Online Access:http://www.hqlo.com/content/6/1/10
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author Viala Muriel
Berdeaux Gilles
Roborel de Climens Aude
Arnould Benoit
author_facet Viala Muriel
Berdeaux Gilles
Roborel de Climens Aude
Arnould Benoit
author_sort Viala Muriel
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>Restoration of functional distance and near vision independently of additional correction remains a goal for cataract surgery. ReSTOR<sup>®</sup>, a new multi-focal intraocular lens (IOL) addresses this issue with an improvement in both distance and near vision, often without need for glasses. This analysis attempted to discuss the patient-reported benefit of ReSTOR<sup>® </sup>using a full but organised representation of data.</p> <p>Methods</p> <p>Two non-randomised, open-label clinical trials conducted in Europe and the United-States were conducted to compare the efficacy of ReSTOR<sup>® </sup>to AcrySof<sup>® </sup>mono-focal IOLs. A total of 710 patients in need of bilateral cataract extraction were included in the pooled study. The TyPE, a patient questionnaire, was fully completed by 672 of them before and after each eye surgery. The TyPE, composed of 67 items measuring overall visual functioning in both conditions (with and without wearing glasses), evaluates limitations, troubles and satisfaction in distance and near vision. A principal component analysis (PCA) of the TyPE questionnaire was performed on pooled data from baseline and post-surgery observations in order to fully represent the change in the TyPE data over time. ReSTOR<sup>® </sup>and mono-focal groups were used as illustrative variables. The coordinates of the first 2 factors were compared between visits and between IOLs (ReSTOR<sup>® </sup>vs. mono-focal), using paired t-tests and t-tests, respectively.</p> <p>Results</p> <p>The first factor of the PCA explained 55% of the variance and represented 'visual functioning and patient satisfaction'. The second factor explained 6% of the variance and was interpreted as 'independence from glasses'. An overall difference in factorial coordinates in both factors was seen between baseline and the first eye surgery, and between the first and the second eye surgery. No difference between ReSTOR<sup>® </sup>and mono-focal IOL groups was observed at baseline. After surgery, ReSTOR<sup>® </sup>treated-patients had higher coordinates on both "visual functioning and satisfaction" and "independence from glasses" factors. Findings observed on the factorial plan were supported by statistical comparisons of factorial coordinates.</p> <p>Conclusion</p> <p>Both mono-focal and ReSTOR<sup>®</sup>-implanted patients improved their visual functioning after bilateral cataract surgery. Moreover, ReSTOR<sup>® </sup>patients reported an additional benefit in independence from glasses as well as in visual functioning and patient satisfaction.</p>
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spelling doaj.art-444d4ea3309543ecaea4bcd7f9c744442022-12-22T03:00:47ZengBMCHealth and Quality of Life Outcomes1477-75252008-01-01611010.1186/1477-7525-6-10Patient-reported benefit of ReSTOR<sup>® </sup>multi-focal intraocular lenses after cataract surgery: Results of Principal Component Analysis on clinical trial dataViala MurielBerdeaux GillesRoborel de Climens AudeArnould Benoit<p>Abstract</p> <p>Background</p> <p>Restoration of functional distance and near vision independently of additional correction remains a goal for cataract surgery. ReSTOR<sup>®</sup>, a new multi-focal intraocular lens (IOL) addresses this issue with an improvement in both distance and near vision, often without need for glasses. This analysis attempted to discuss the patient-reported benefit of ReSTOR<sup>® </sup>using a full but organised representation of data.</p> <p>Methods</p> <p>Two non-randomised, open-label clinical trials conducted in Europe and the United-States were conducted to compare the efficacy of ReSTOR<sup>® </sup>to AcrySof<sup>® </sup>mono-focal IOLs. A total of 710 patients in need of bilateral cataract extraction were included in the pooled study. The TyPE, a patient questionnaire, was fully completed by 672 of them before and after each eye surgery. The TyPE, composed of 67 items measuring overall visual functioning in both conditions (with and without wearing glasses), evaluates limitations, troubles and satisfaction in distance and near vision. A principal component analysis (PCA) of the TyPE questionnaire was performed on pooled data from baseline and post-surgery observations in order to fully represent the change in the TyPE data over time. ReSTOR<sup>® </sup>and mono-focal groups were used as illustrative variables. The coordinates of the first 2 factors were compared between visits and between IOLs (ReSTOR<sup>® </sup>vs. mono-focal), using paired t-tests and t-tests, respectively.</p> <p>Results</p> <p>The first factor of the PCA explained 55% of the variance and represented 'visual functioning and patient satisfaction'. The second factor explained 6% of the variance and was interpreted as 'independence from glasses'. An overall difference in factorial coordinates in both factors was seen between baseline and the first eye surgery, and between the first and the second eye surgery. No difference between ReSTOR<sup>® </sup>and mono-focal IOL groups was observed at baseline. After surgery, ReSTOR<sup>® </sup>treated-patients had higher coordinates on both "visual functioning and satisfaction" and "independence from glasses" factors. Findings observed on the factorial plan were supported by statistical comparisons of factorial coordinates.</p> <p>Conclusion</p> <p>Both mono-focal and ReSTOR<sup>®</sup>-implanted patients improved their visual functioning after bilateral cataract surgery. Moreover, ReSTOR<sup>® </sup>patients reported an additional benefit in independence from glasses as well as in visual functioning and patient satisfaction.</p>http://www.hqlo.com/content/6/1/10
spellingShingle Viala Muriel
Berdeaux Gilles
Roborel de Climens Aude
Arnould Benoit
Patient-reported benefit of ReSTOR<sup>® </sup>multi-focal intraocular lenses after cataract surgery: Results of Principal Component Analysis on clinical trial data
Health and Quality of Life Outcomes
title Patient-reported benefit of ReSTOR<sup>® </sup>multi-focal intraocular lenses after cataract surgery: Results of Principal Component Analysis on clinical trial data
title_full Patient-reported benefit of ReSTOR<sup>® </sup>multi-focal intraocular lenses after cataract surgery: Results of Principal Component Analysis on clinical trial data
title_fullStr Patient-reported benefit of ReSTOR<sup>® </sup>multi-focal intraocular lenses after cataract surgery: Results of Principal Component Analysis on clinical trial data
title_full_unstemmed Patient-reported benefit of ReSTOR<sup>® </sup>multi-focal intraocular lenses after cataract surgery: Results of Principal Component Analysis on clinical trial data
title_short Patient-reported benefit of ReSTOR<sup>® </sup>multi-focal intraocular lenses after cataract surgery: Results of Principal Component Analysis on clinical trial data
title_sort patient reported benefit of restor sup r sup multi focal intraocular lenses after cataract surgery results of principal component analysis on clinical trial data
url http://www.hqlo.com/content/6/1/10
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AT roboreldeclimensaude patientreportedbenefitofrestorsupsupmultifocalintraocularlensesaftercataractsurgeryresultsofprincipalcomponentanalysisonclinicaltrialdata
AT arnouldbenoit patientreportedbenefitofrestorsupsupmultifocalintraocularlensesaftercataractsurgeryresultsofprincipalcomponentanalysisonclinicaltrialdata