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Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2008

Open Access 01-12-2008 | Research

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

Authors: Gilles Berdeaux, Muriel Viala, Aude Roborel de Climens, Benoit Arnould

Published in: Health and Quality of Life Outcomes | Issue 1/2008

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Abstract

Background

Restoration of functional distance and near vision independently of additional correction remains a goal for cataract surgery. ReSTOR®, 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® using a full but organised representation of data.

Methods

Two non-randomised, open-label clinical trials conducted in Europe and the United-States were conducted to compare the efficacy of ReSTOR® to AcrySof® 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® and mono-focal groups were used as illustrative variables. The coordinates of the first 2 factors were compared between visits and between IOLs (ReSTOR® vs. mono-focal), using paired t-tests and t-tests, respectively.

Results

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® and mono-focal IOL groups was observed at baseline. After surgery, ReSTOR® 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.

Conclusion

Both mono-focal and ReSTOR®-implanted patients improved their visual functioning after bilateral cataract surgery. Moreover, ReSTOR® patients reported an additional benefit in independence from glasses as well as in visual functioning and patient satisfaction.
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Literature
1.
2.
Thylefors B, Negrel AD, Pararajasegaram R, Dadzie KY: Global data on blindness. Bull World Health Organ 1995, 73: 115–121.PubMedCentralPubMed
3.
4.
Gimbel HV, Sanders DR, Raanan MG: Visual and refractive results of multifocal intraocular lenses. Ophthalmology 1991, 98: 881–887.CrossRefPubMed
5.
Javitt JC, Wang F, Trentacost DJ, Rowe M, Tarantino N: Outcomes of cataract extraction with multifocal intraocular lens implantation: functional status and quality of life. Ophthalmology 1997, 104: 589–599.CrossRefPubMed
6.
Javitt JC, Steinert RF: Cataract extraction with multifocal intraocular lens implantation: a multinational clinical trial evaluating clinical, functional, and quality-of-life outcomes. Ophthalmology 2000, 107: 2040–2048. 10.1016/S0161-6420(00)00368-7CrossRefPubMed
7.
Lindstrom RL: Food and Drug Administration study update. One-year results from 671 patients with the 3M multifocal intraocular lens. Ophthalmology 1993, 100: 91–97.CrossRefPubMed
8.
Rossetti L, Carraro F, Rovati M, Orzalesi N: Performance of diffractive multifocal intraocular lenses in extracapsular cataract surgery. J Cataract Refract Surg 1994, 20: 124–128.CrossRefPubMed
9.
Steinert RF, Post CT Jr., Brint SF, Fritch CD, Hall DL, Wilder LW, Fine IH, Lichtenstein SB, Masket S, Casebeer C, .: A prospective, randomized, double-masked comparison of a zonal-progressive multifocal intraocular lens and a monofocal intraocular lens. Ophthalmology 1992, 99: 853–860.CrossRefPubMed
10.
Steinert RF, Aker BL, Trentacost DJ, Smith PJ, Tarantino N: A prospective comparative study of the AMO ARRAY zonal-progressive multifocal silicone intraocular lens and a monofocal intraocular lens. Ophthalmology 1999, 106: 1243–1255. 10.1016/S0161-6420(99)00704-6CrossRefPubMed
11.
Vaquero M, Encinas JL, Jimenez F: Visual function with monofocal versus multifocal IOLs. J Cataract Refract Surg 1996, 22: 1222–1225.CrossRefPubMed
12.
Wallace RB III: Multifocal vision after cataract surgery. Curr Opin Ophthalmol 1998, 9: 66–70. 10.1097/00055735-199802000-00012CrossRefPubMed
13.
Davison JA, Simpson MJ: History and development of the apodized diffractive intraocular lens. J Cataract Refract Surg 2006, 32: 849–858. 10.1016/j.jcrs.2006.02.006CrossRefPubMed
14.
Blaylock JF, Si Z, Vickers C: Visual and refractive status at different focal distances after implantation of the ReSTOR multifocal intraocular lens. J Cataract Refract Surg 2006, 32: 1464–1473. 10.1016/j.jcrs.2006.04.011CrossRefPubMed
15.
Chiam PJ, Chan JH, Aggarwal RK, Kasaby S: ReSTOR intraocular lens implantation in cataract surgery: quality of vision. J Cataract Refract Surg 2006, 32: 1459–1463. 10.1016/j.jcrs.2006.04.015CrossRefPubMed
16.
Kohnen T, Allen D, Boureau C, Dublineau P, Hartmann C, Mehdorn E, Rozot P, Tassinari G: European multicenter study of the AcrySof ReSTOR apodized diffractive intraocular lens. Ophthalmology 2006, 113: 584. 10.1016/j.ophtha.2005.11.020CrossRefPubMed
17.
Souza CE, Gerente VM, Chalita MR, Soriano ES, Freitas LL, Belfort R Jr.: Visual acuity, contrast sensitivity, reading speed, and wavefront analysis: pseudophakic eye with multifocal IOL (ReSTOR) versus fellow phakic eye in non-presbyopic patients. J Refract Surg 2006, 22: 303–305.PubMed
18.
Souza CE, Muccioli C, Soriano ES, Chalita MR, Oliveira F, Freitas LL, Meire LP, Tamaki C, Belfort R Jr.: Visual performance of AcrySof ReSTOR apodized diffractive IOL: a prospective comparative trial. Am J Ophthalmol 2006, 141: 827–832. 10.1016/j.ajo.2005.12.031CrossRefPubMed
19.
Chassany O, Sagnier P, Marquis P, Fullerton S, Aaronson N, for the European Regulatory Issues on Quality of Life Assessment group: Patient-Reported Outcomes: the example of Health-Related Quality of Life - a European guidance document for the improved integration of Health-Related Quality of Life assessment in the drug regulatory process. Drug Information Journal 2002, 36: 209–238.CrossRef
20.
IT J: Principal Component Analysis - Second Edition. New York, Springer Series in Statistics; 2002.
21.
LA M: Multiple analysis in clinical trials: fundamentals for investigators, Statistics for biology and health. New York, Springer; 2003.
22.
RL O: Satisfaction: a behavioural perspective of the consumer. New York, McGraw Hill College; 1996.
23.
Brenner MH, Curbow B, Javitt JC, Legro MW, Sommer A: Vision change and quality of life in the elderly. Response to cataract surgery and treatment of other chronic ocular conditions. Arch Ophthalmol 1993, 111: 680–685.CrossRefPubMed
24.
Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD: Development of the 25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol 2001, 119: 1050–1058.CrossRefPubMed
25.
Pesudovs K, Garamendi E, Elliott DB: The Quality of Life Impact of Refractive Correction (QIRC) Questionnaire: development and validation. Optom Vis Sci 2004, 81: 769–777. 10.1097/00006324-200410000-00009CrossRefPubMed
Metadata
Title
Patient-reported benefit of ReSTOR® multi-focal intraocular lenses after cataract surgery: Results of Principal Component Analysis on clinical trial data
Authors
Gilles Berdeaux
Muriel Viala
Aude Roborel de Climens
Benoit Arnould
Publication date
01-12-2008
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2008
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/1477-7525-6-10

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