From Health Economics and Outcomes Research, IMS Health, London, United Kingdom (Agresta, Donatti); FreeVis LASIK Center, Medical Faculty Mannheim of the University of Heidelberg, Mannheim, Germany (Knorz); Department of Ophthalmology, Goethe University, Frankfurt, Germany (Kohnen); and Market Access and Reimbursement, Alcon Laboratories Inc, Cointrin, Switzerland (Jackson).
The research was financially supported by Alcon Laboratories Inc UK.
Mr Agresta and Dr Donatti were paid consultants to Alcon Laboratories Inc and are employees of IMS Health. Drs Knorz and Kohnen are consultants to Alcon Laboratories Inc. Mr Jackson is an employee of Alcon Laboratories Inc.
Study concept and design (B.A., C.D., D.J.); data collection (B.A.); analysis and interpretation of data (B.A., M.C.K., T.K., C.D.); drafting of the manuscript (B.A.); critical revision of the manuscript (B.A., M.C.K., T.K., C.D., D.J.); statistical expetise (B.A., C.D., D.J.); obtained funding (B.A., C.D., D.J.); administrative, technical, or material support (B.A., C.D., D.J.); supervision (C.D.)
Correspondence: Blaise Agresta, MPH, Health Economics and Outcomes Research, IMS Health, Harewood Ave, London NW1 6JB, United Kingdom. E-mail: email@example.com
Cataract surgery is one of the most commonly performed surgeries in the National Health Services (NHS). In the United Kingdom, 10% of persons aged ⩾65 years have received cataract surgery and 30% of the population have been found to have a visually impairing cataract in one or both eyes.1 In this population (people aged ⩾65 years in the United Kingdom), it is estimated that 2.4 million people have a visually impairing cataract in one or both eyes and 225 000 new cases are predicted annually.2
Presbyopia is an age-related loss of lens accommodation that results in an inability to focus at near distances. The global prevalence of presbyopia has been estimated to be 1.04 billion (in 2005)3 and is expected to rise to 1.8 billion by 2050. An estimated 9.9 million people in Europe and North America, 4.8 million people in Japan, and 1.2 million people in Australia and New Zealand live with uncorrected or undercorrected presbyopia.3 The most commonly used treatments for presbyopia include spectacles, contact lenses, and bifocal contact lenses.4 Presbyopia and cataracts reduce patient quality of life (QOL).5,6 The use of a multifocal intraocular lens (IOL) is designed to replace the cataract lens of an eye and reduce presbyopia by factoring a change in the focal point created by the lens (the multifocal attribute of the IOL). Thus, if multifocal IOLs are safe and efficient, an increase in QOL should be observed in cataract patients with presbyopia. This increase in QOL would not have been as significant had only cataracts or presbyopia been treated in this patient population.
This systematic review attempts to identify published literature reporting the postoperative uncorrected visual acuity outcomes in patients undergoing cataract surgery with presbyopia and to show how patients can achieve virtually normal vision with the use of all multifocal IOLs.
The systematic review was conducted to evaluate the efficacy of multifocal IOLs in presbyopic cataract patients. Databases used in the search included: Medline, Medline In-Process (from 1948 to present), Embase (from 1988 to 2011), and Evidence Based Medicine Reviews (Cochrane Database of Systematic Reviews) (2005–2011), ACP Journal Club (1991–2011), Database of Abstracts of Reviews of Effects (first quarter, 2011), Cochrane Central Register of Controlled Trials (fourth quarter, 2010), Cochrane Methodology Register (first quarter, 2010), Health Technology Assessment (first quarter, 2011), and NHS Economic Evaluation Database (first quarter, 2011). These searches were accessed via the OVID platform to search for studies reporting uncorrected visual acuity in a presbyopic population with cataracts implanted with multifocal IOLs. The search terms used included: lens diseases, cataract, aphakia, cataract extraction, multifocal, lens implantation, and lenses-intraocular. The search term “bifocal” was not included in the search as the authors were only analyzing the outcomes from multifocal IOLs. An analysis of how the individual studies identified in the literature search were excluded was achieved using the Quality of Reporting of Meta-analyses (QUORUM) chart. Inclusion/exclusion criteria were used to systematically exclude any studies that did not report relevant populations (presbyopic patients with cataracts), interventions (multifocal IOL implantation), comparators (other multifocal IOL implantation), or outcomes (uncorrected visual acuity) for the review. The following types of studies were excluded from the review: those that did not report uncorrected or corrected visual acuity; those that did not report outcomes in a presbyopic cataract population; and those that reported outcomes in a language other than English. Studies using a patient population with true cataracts were included; studies with a population of refractive lens exchange patients were excluded. Studies that did not specify a cataract population were assumed to be a mixed patient population (cataract patients and refractive lens exchange) and were excluded. Likewise studies that specified a presbyopic patient group were included in the search (studies reporting refractive lens exchange patients were excluded). Although patients who undergo cataract removal become presbyopic, the authors found it imperative for a presbyopic patient group to be stated to reduce any possible underlying bias.
This analysis focused on the outcome uncorrected visual acuity. Although the World Health Organization (WHO) defines visual impairment and blindness according to visual acuity with “best possible correction,” evidence suggests that uncorrected visual acuity has a significant impact on vision-related QOL.7,8 Before QOL improvements caused by multifocal IOLs in presbyopic cataract patients are assessed, it is necessary to demonstrate the efficacy of multifocal IOLs. The safety of multifocal IOLs and the change in QOL due to multifocal IOLs were not analyzed in this review.
The unit measurement of uncorrected visual acuity varies across many studies. The Snellen scale, Jaeger scale, decimal of the Snellen scale, and logarithm of the minimum angle of resolution (logMAR) are the most commonly used units of measurement.9 Converting these units of measurement into a standardized unit has statistical challenges where individual (patient) level data are not available.9 When comparing changes in visual acuity in this study, conversion tables supplied by the Journal of Refractive Surgery were used to convert to logMAR values and visual acuity abbreviations were adopted from Kohnen.10,11 Published literature exists to suggest that transforming group-level mean and standard deviation of visual acuity across different levels of measurement is possible.9 But to transform group-level data, a “reasonable size” patient population (N⩾30) is needed.9 An a priori judgment was therefore made that if more than one third of the outcome patient groups, which were identified through the systematic review, had a patient population <30, transformation of the unit measurements would not occur.
Literature Search Results
The systematic review identified 29 studies that measured uncorrected visual acuity in a presbyopic population with cataracts implanted with multifocal IOLs (Fig 1) with a breakdown of study type shown in Figure 2. The outcomes of these studies are reported in Table 1. A range of different outcome measurement units were reported, including Snellen measurement, decimal of the Snellen measurement, Jaeger score, and logMAR.
Figure 1. Quality of Reporting of Meta-analyses (QUORUM) chart of the review process.
Figure 2. Breakdown of the analysis of studies identified through the systematic review. RCT = randomized controlled trial
Some studies identified through the systematic review approach measured visual acuity as a proportion of patients who had a certain level of visual acuity or better.24,41 Studies that reported the lowest visual acuity in the total population were included in the analysis, whereas studies that did not report the total population were excluded on the basis of incomplete data.
These 29 studies showed statistical significance of the multifocal IOL when comparing two models of multifocal IOLs or between pre- and postoperative results. Studies that compared pre- and postoperative results reported statistical significance and provided evidence to support the efficacy of multifocal IOLs for cataract patients with presbyopia. The systematic review identified 2 randomized controlled trials, 5 observational studies, and 2 prospective cohorts that reported a comparison between pre- and postoperative visual acuity (Table 1). Every study that reported the comparison of pre- and postoperative values for UDVA and UNVA showed differences that were statistically significant postoperatively.
The systematic review identified 25 studies reporting uncorrected near visual acuity (UNVA) and 26 studies reporting uncorrected distance visual acuity (UDVA). One study reported uncorrected intermediate visual acuity (UIVA) (Table 2). Nine brands of multifocal IOLs were identified in these studies: ReSTOR (SA60D3, SN6AD1; Alcon Laboratories Inc, Ft Worth, Texas), ReZoom (NXG1; Abbott Medical Optics [AMO], Santa Ana, California), CeeOn (811E; Pharmacia & Upjohn, Kalamazoo, Michigan), Array (SA40N; AMO), Tecnis (ZM900; AMO), Acri.LISA (366D; Carl Zeiss Meditec, Jena, Germany), Rayner M-Flex (630F; Rayner Intraocular Lenses Ltd, East Sussex, United Kingdom), PA154N (AMO), and MS612 (HumanOptics, Erlangen, Germany). A limitation of the results exists because of a mix between outcomes measured using the Snellen method, Jaeger method, or decimal or log-MAR scores. Using the Snellen scale, visual acuity closest to 20/20 (in feet) or 6/6 (in meters) represents standard or normal sight.42 Using the decimal scale, standard or normal sight is 1.00. In the logMAR scale, 20/20 is equivalent to 0.00. The Jaeger scale defines standard or normal sight at J1+.
Table 2: Results of the Systematic Review for Uncorrected Intermediate Visual Acuity
This analysis, both in terms of reported outcomes of UNVA and UDVA, shows that the gains in improvement for UDVA appear to be greater than gains in UNVA. Postoperative UDVA values were closer to a normal sight score (20/20 Snellen) in 28 models of multifocal IOLs tested across the 36 models in 29 studies. Uncorrected near visual acuity was closer to normal sight in 6 models and postoperative UNVA was equivalent to UDVA in 2 studies.
Greater improvements in UDVA were also reported compared to UNVA. The greatest increase in visual acuity was reported by Cezón-Prieto and Bautista,20 being the only identified study that reported UIVA. The smallest improvements in visual acuity were reported by Alió et al18 when measuring binocular visual acuity. De Vries et al30 reported the mean visual acuity with the closest value to normal visual acuity (20/20) when measuring both UDVA and UNVA. Yang et al27 reported the least gain in UNVA. Akaishi et al17 reported the least gain in UDVA. The greatest improvements in UNVA were observed by De Vries et al.30
Twenty-one of the 29 studies reported different measures of QOL,12,13 spectacle independence,39 and visual disturbances such as halos23 or glare.36 There was no consistency across studies in reporting these outcomes. Methods included individually designed questionnaires14; the Vision Function (VF) −14,16 VF-7,38 or VF2543 questionnaire; reporting in four dimensions (eg, satisfied, dissatisfied, very satisfied, not satisfied32 or none, mild, moderate, severe24); reporting different outcomes as patient numbers,20 percentage of patients,30 or mean values26; and reported outcomes on different scales (scoring with a lower number representing a better value15 or a higher number indicating a better value14). Considering these limitations, QOL measured by Gunenc and Ce-lik13 resulted in 100% satisfaction in overall vision with the CeeOn and Array multifocal IOLs. Rekas and Zelichowska25 reported the worst outcomes with 60% of patients (6 of 10) reporting a mild halo effect with the ReSTOR multifocal IOL.
The objective of this study was to evaluate published results of uncorrected visual acuity in patients with cataracts and presbyopia who received multifocal IOLs. As the goal of multifocal IOLs is to enable patients to be less dependent on spectacles following surgery,37 uncorrected visual acuity is an appropriate surrogate marker for spectacle independence.
The aggregate results of these studies provide evidence to suggest that multifocal IOL implantation in patients with cataracts and presbyopia improves visual acuity. Although only one-third of the studies (10/30) reported pre- and postoperative values, the results of studies only reporting postoperative values were similar to the postoperative results in the studies that reported pre- and postoperative values. Of the studies that reported statistical significance, all studies reported significant differences between pre- and postoperative values. Published literature exists reporting the comparison between monofocal and multifocal IOLs and meta-analyses on multifocal IOLs,44–46 but no systematic reviews have been published reporting the outcomes of visual acuity in multifocal IOLs for cataract patients with presbyopia. Prior to this study, there has only been one known evaluation comparing studies measuring outcomes in multifocal IOLs.46 This study shows the collective improvement of visual acuity, both for hyperopia and myopia.
Spectacle independence and QOL are important factors when considering the use of multifocal IOLs for presbyopic patients.47 A Cochrane review updated in 2008 identified 13 studies that measured patient satisfaction with vision associated with either multifocal or monofocal IOLs.44 Using various QOL instruments, the review reported satisfaction with multifocal IOLs between 62.8% and 96%.48,49 Of the 13 possible studies that were identified through the Cochrane report, 8 studies reported a preference for multifocal IOLs.44
A limitation of this study was that it did not measure the outcome of spectacle independence and the impact this has on the QOL of the patient population. Although it was not within the scope of this systematic review to report the outcomes of QOL studies, the literature needs to be updated with a systematic review reporting these outcomes. Furthermore, an analysis on studies reporting the association between QOL and uncorrected visual acuity is needed. A number of instruments can be used to measure QOL in multifocal IOL patients, and it is important to use a validated instrument when measuring these outcomes.34
Adverse events are also an important consideration when evaluating multifocal IOLs. Glare, night vision, color perception, halos, distorted vision, and blurred vision are possible adverse events that can occur with the use of IOLs.47,50 An updated systematic review of these outcomes would also be valuable.
A limitation with the supporting evidence in the available data is the lack of consistency with regard to efficacy parameters and units of measurement among studies reporting multifocal IOL visual acuity outcomes. Mean visual acuity after cataract surgery is the most commonly reported method identified in studies measuring outcomes related to multifocal IOLs; proportion of patients achieving a minimum visual acuity level has been another highly reported method. Statistical challenges exist in comparing this proportional method of reporting with other studies. Without individual patient level data, it is not possible to combine the results of studies that measured either the distribution or the proportion of visual acuity outcomes.
This systematic review analyzed studies that reported improvements in uncorrected visual acuity in cataract patients with presbyopia. Significant improvements in UNVA and UDVA across the studies were identified. Uncorrected visual acuity is a surrogate marker for spectacle independence and thus increased QOL. Further analyses are needed on studies reporting spectacle independence and QOL in regards to multi-focal IOL implantation.
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Results of the Systematic Review of Patients With Cataract and Presbyopia With Multifocal IOL Implantation
|Study Type/Study (y)||Lens||Unit of Measure (Study Length)||No. of Eyes||Monocular/Binocular||Patient Age (y)||UDVA||UNVA|
|Randomized Controlled Trial|
|Chiam et al12 (2007)||ReSTORSA60D3||Snellen (6 mo)||100||Binocular||67.8±8.1||—||20/23||NR||—||20/26||NR|
|ReZoomNXG1||Snellen (6 mo)||100||Binocular||69.0±7.0||—||20/21||NR||—||20/34||NR|
|Gunenc & Celik13 (2008)||CeeOn 811E||Snellen/Jaeger (6 mo)||10||Monocular||68.2||—||20/32 or better||NR||—||J2 or better||NR|
|Array SA40N||Snellen/Jaeger (6 mo)||10||Monocular||64.4||—||20/32 or better||NR||—||J4 or better||NR|
|Javitt et al14 (2000)||Array SA40N||Snellen (3 mo)||123||Binocular||NR||—||20/21||NR||—||20/26||NR|
|Lane et al15 (2010)||ReSTORSN6AD1||Snellen (6 mo)||147||Binocular||69±8||20/56||20/22||<.0001||20/83||20/25||<.0001|
|LogMAR (6 mo)||147||Binocular||0.45±0.25||0.04±0.13||<.0001||0.62±0.31||0.1±0.16||.0001|
|Nijkamp et al16 (2004)||Array SA40N||LogMAR (3 mo) for UDVA, decimal for UNVA||68||NR||72±7.7||0.53 (0.3)||0.13 (0.2)||NR||0.5 (0.3)||0.8±0.3||NR|
|Akaishi et al17 (2009)||TecnisZM900||LogMAR/Jaeger (3 mo)||16||NR||67.9±8.2||—||0.32±0.07||<.001||—||J1.25||NR|
|Alió et al18 (2008)||Acri.LISA 366D||Decimal (6 mo)||69||Binocular||59||0.27±0.23||0.89±0.15||<.001||0.26±0.26||0.9±0.15||<.001|
|Decimal (6 mo)||69||Monocular||59||0.54±0.29||0.75±0.21||<.001||0.24±0.25||0.76±0.22||<.001|
|Alió et al19 (2011)||Acri.LISA 366D||LogMAR (6 mo)||48||NR||58.3±8.8||0.61±0.39||0.11±0.11||<.001||0.82±0.33||0.12±0.11||<.001|
|Cezón-Prieto & Bautista20 (2010)||RaynerM-Flex 630F||LogMAR (12 mo)||32||Monocular||68.1±12.0||1.01±0.72||0.09±0.09||NR||1.11±0.42||0.28±0.11||NR|
|Lin et al21 (2001)||Array||Decimal (3 mo)||37||NR||63||—||0.8||NR||—||0.6||NR|
|Mesci et al22 (2010)||ReSTORSA60D3||Decimal (12 mo)||20||Monocular||65.6±7.1||—||0.99±0.03||NR||—||—||NR|
|Moreno23 (2010)||ReSTORSN6AD3||LogMAR (6 mo)||38||NR||63.42±8.55||0.57±0.31||0.11±0.12||<.00001||0.76±0.4||0.12±0.09||.00001|
|Pineda-Fernandez et al24 (2004)||Array SA40N||Snellen (3 mo)||70||NR||61.54±11||—||20/40 or better||NR||—||20/40 or better||NR|
|Rekas & Zelichowska25 (2006)||ReSTORSN60D3||Decimal (6 mo)||20||NR||64±9||0.3±0.18||0.9±0.1||NR||—||—||NR|
|Walkow et al26 (1997)||811E||Snellen/Jaeger (12 mo)||40||Monocular||64.8||—||—||—||—||J1||NR|
|PA154N||Snellen/Jaeger (12 mo)||40||Monocular||—||—||—||—||J4||NR|
|Yang et al27 (2000)||Array SA-40N||Decimal (2 mo)||20||NR||66.0±4.4||—||0.68±0.27||NR||—||0.49±0.15||NR|
|Bi et al28 (2008)||ReSTORSN60D3||Decimal (6 mo)||40||NR||53.0±4.5||—||—||NR||—||—||NR|
|de Santhiago et al29 (2009)||ReSTORSN60D3||LogMAR (3 mo)||20||NR||NR||—||0.74±0.2||NR||—||0.96±0.10||NR|
|TecnisZM900||LogMAR (3 mo)||20||NR||NR||—||0.76±0.22||NR||—||0.93±0.14||NR|
|De Vries et al30 (2008)||ReSTORSA60D3||LogMAR (3 y)||44||Binocular||74.2±8.7||—||0.115±0.173||NR||—||0.014±0.035||NR|
|ReSTORSA60D3||LogMAR (3 y)||44||Monocular||—||0.197±0.185||NR||—||0.058±0.081||NR|
|Gerten et al31 (2009)||MS612+MS714||LogMAR (3 mo)||56||Binocular||65±12||—||0.02±0.07||NR||—||0.08±0.08||NR|
|MS612+MS714||LogMAR (3 mo)||56||Monocular||65±12||—||0.10±0.11||NR||—||0.16±0.13||NR|
|Gierk-Ciaciura et al32 (2010)||ReZoom||LogMAR (6 mo)||20||Monocular||56.0±5.2||0.79±0.16||0.11±0.01||<.001||0.73±0.18||0.20±0.04||<.001|
|ReSTOR||LogMAR (6 mo)||20||Monocular||56.8±6.0||0.65±0.08||0.17±0.02||<.001||0.67±0.16||0.11±0.03||<.001|
|Tecnis||LogMAR (6 mo)||20||Monocular||55.6±6.9||0.70±0.09||0.14±0.02||<.001||0.61±0.16||0.12±0.03||<.001|
|Mesci et al33 (2010)||Tecnis||LogMAR (12 mo)||22||Binocular||61.7±7.4||0.13±0.13||−0.05±0.05||NR||—||0.25±0.075||NR|
|ReZoom||LogMAR (12 mo)||20||Binocular||61.5±8.3||0.15±0.1||−0.05±0.05||NR||—||0.125±0.06||NR|
|TecnisZM900||LogMAR (12 mo)||22||Monocular||61.7±7.4||0.13±0.13||0.06±0.05||NR||—||0.07±0.075||NR|
|ReZoom||LogMAR (12 mo)||20||Monocular||61.5±8.3||0.15±0.1||0.06±0.05||NR||—||0.15±0.05||NR|
|Palomino Bautista et al34 (2009)||Tecnis||LogMAR (7 mo)||250||Monocular||68.5±9.9||—||0.144±0.101||NR||—||0.215±0.082||NR|
|Renieri et al35 (2007)||ReSTORSA60D3||LogMAR (median) (3 mo)||18||NR||66.27±4.34||—||0.10||NR||—||0.10||NR|
|ArrayAA50||LogMAR (median) (3 mo)||18||NR||—||0.10||NR||—||0.25||NR|
|Souza et al36 (2006)||ReSTOR||LogMAR (4 mo)||50||Binocular||68.3±9.2||—||0.16±0.13||NR||—||0.09±0.10||NR|
|Toto et al37 (2007)||TecnisTM900||LogMAR (6 mo)||14||NR||60.86±6.64||—||—||NR||—||HC: 0.16±0.22LC: 0.51±0.21||NR|
|ReSTOR||LogMAR (6 mo)||14||NR||60.79±7.11||—||—||NR||—||HC: 0.13±0.12LC: 0.50±0.11||NR|
|Zhao et al38 (2010)||ReSTORSA60D3||LogMAR (median) (6 mo)||72||Monocular||62±8||—||1.07||NR||—||0.66||NR|
|Forte & Ursoleo39 (2009)||ReZoom||LogMAR/Jaeger (2 y)||55||Monocular||71±7||0.5±0.3||0.04±0.08||<.001||J7.8±0.6||J2.3±0.7||<.001|
|Zhao et al40 (2009)||ReSTORSA60D3||LogMAR (31 mo)||54||Monocular||62±8||—||0.10||NR||—||0.17||NR|
Results of the Systematic Review for Uncorrected Intermediate Visual Acuity
|Study Type/Study (y)||Lens||Unit of Measure (Study Length)||No. of Eyes||Patient Age (y)||UIVA|
|Cezón-Prieto & Bautista (2010)20||Rayner M-Flex 630F||LogMAR (12 mo)||32||68.1±12.0||1.06±0.30 (monocular)1.02±0.28 (binocular)||0.15±0.05 (monocular)0.16±0.05 (binocular)|