Optometry (2010) 81, 598-607

Compliance with soft contact lens replacement schedules and associated contact lensrelated ocular complications: The UCLA Contact Lens Study
Karen K. Yeung, O.D.,a Julie F.Y. Forister, O.D.,b Eric F. Forister, Ph.D.,c Marisa Y. Chung, O.D.,d Silvia Han, B.S.,e and Barry A. Weissman, O.D., Ph.D.f
UCLA Arthur Ashe Student Health, Los Angeles, California; bUC Berkeley School of Optometry, University of California, Berkeley, California; cCornerstone Research, San Francisco, California; dKaiser Permanente, San Diego, California; e Southern California College of Optometry, Fullerton, California; and fJules Stein Eye Institute, Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California.
Abstract BACKGROUND: Failure to comply with the manufacturers recommended replacement frequency (MRRF) is expected to result in ocular complications. The goal of this study is to evaluate the empirical relationship between compliance with MRRF and the presence of ocular complications. METHODS: All soft contact lens-wearing patients who presented at either of 2 clinics were evaluated prospectively for contact lens-related complications and for compliance with MRRF. RESULTS: Compliance with MRRF varies significantly across replacement modality (P , 0.01) and lens solution type (P 5 0.04). Among noncompliant patients, average days of overwear beyond MRRF significantly varies across age group (P 5 0.02), lens material type (P 5 0.01), and lens solution type (P 5 0.02). Regression analysis controlling for demographic factors and lens and solution type found a marginally significant (P 5 0.07) positive effect of days of overwear on average complications per eye. CONCLUSIONS: We find noncompliance broadly present across demographic groups and patient types and marginally positively related to complications. Optometry 2010;81:598-607
a

KEYWORDS
Compliance; Contact lenses; Contact lens solutions; Complications; Disposable contact lenses; Manufacturers recommended replacement frequency

Patient noncompliance with appropriate contact lens (CL) care is commonplace. Recent studies of CL solutionrelated corneal infections suggest noncompliance is a factor among affected patients.1,2 Previous studies found overall noncompliance in CL care ranging from 40% to 74% of wearers.3-5 Upper conjunctival papillae, upper lid conjunctival hyperemia, and limbal congestion are complications reported with CL wear beyond the manufacturers recommended
Corresponding author: Karen K. Yeung, O.D., UCLA Arthur Ashe Student Health, 221 Westwood Plaza, Room 212, Los Angeles, California 90095-1703. E-mail: Impyeyes99@yahoo.com

replacement frequency (MRRF).6 Changes in physicochemical surface properties of lenses secondary to soilage (caused by CL overwear) were accompanied by reports of discomfort in 6 of 10 new CL wearers.7 Overwear may be the most common noncompliant patient behavior6 and is the index of noncompliance we chose to study here. This study is an extension of our previous report8 documenting the prevalence of CL-related complications at 2 university clinic settings. The goal of this study is 3-fold: (1) to evaluate patient compliance with soft CL (SCL) replacement based on MRRF, (2) to quantify the number of days patients overwear their CLs beyond MRRF, and (3) to determine if there is a correlation between CL compliance

1529-1839/$ -see front matterThis is a U.S. government work. There are no restrictions on its use. Published by Elsevier Inc. on behalf of the American Optometric Association. doi:10.1016/j.optm.2010.01.013

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599 further analysis using Stata 10 (Stata Corporation; College Station, Texas).8

with MRRF and CL-related complications. We analyzed SCL replacement schedules in patients using different lens materials and compared them with those of the MRRF. We hope that this project may further the understanding of noncompliance in SCL replacement and provide an update on the prevalence of CL-related complications that may be associated with SCL wear beyond MRRF. Several studies have found that silicone hydrogels have fewer symptoms and signs of dryness, conjunctival redness, and ocular irritation than traditional hydrogel CLs.9-12 Because noncompliance has been found to be higher when the treatment is prophylactic or suppressive,13 one of our secondary questions is to determine if the decrease in symptoms from silicone hydrogel CLs increases the tendency to overwear CLs.

Statistical analysis
When comparing compliance rates for different groups we used c2 tests when expected cell frequencies were 5 or more, and Fisher Exact tests when expected cell frequencies were less than 5. Expected cell frequencies were calculated based on the compliance rates for replacement modalities reported by Dumbleton et al.5 The c2 and Fisher Exact tests are appropriate because compliance is a binary variable (i.e., can only take 1 of 2 values: compliant or not). Post-hoc analyses of compliance across categories were based on estimates from a logit regression and were nondirectional (i.e., 2-tailed). When comparing average complications per eye and days overwear across groups, we rejected equality of variance using Bartletts and Levenes test for equal variances. As such, the standard remedial measure of implementing weighted least squares (WLS) was used when testing for differences in averages across groups. 16 All comparisons of averages across groups were performed with Wald tests and were nondirectional (i.e., 2-tailed). Given that complications per eye and days overwear were not normally distributed, as a robustness check we also performed the Kruskal-Wallis equality-of-population rank test, which tests for equality of medians across groups. When reporting average complications per eye, we list the mean 6 1 SD of the sample. When reporting correlations based on average complications per eye or days overwear across groups, we used Spearman correlations. This test is appropriate because these variables are not normally distributed but are ordinal.

Methods
As an extension to our earlier report8 on the prevalence of CL-related complications, data from our earlier study were used.

Subject identication and recruitment from the previous study

The SCL patient data used for this analysis were extracted from our previous CL-related complication study, which includes patients seen from April 2006 to March 2007 at 2 UCLA eye care clinics.8 The method of subject identication and recruitment may be found in our previous study. Note that the sample size for the current study is smaller than that of the previous study because we are focused on just a subset of patients, namely those who wore SCLs. The data utilized here recorded the presence or absence of each complication but not severity. Patients were recorded as having complications if they had an Efron rating of 1 or greater.14 We recorded papillae with an Efron rating of 4 as giant papillary conjunctivitis (GPC). Our denition of overwear in this study is based on the difference between the patients self-reported replacement schedule and the MRRF. MRRF schedules were found in Tylers Quarterly.15

Level of analysis
Patients in our sample were almost always either SCL compliant in both eyes or neither of their eyes. As such, compliance appears to be a patient-level, and not eye-level, decision. Therefore, the level of observation in our sample is the patient. Patients were listed as compliant if all of their CLs were replaced according to or earlier than MRRF. Patients were recorded as noncompliant if they overwore CLs in either eye beyond MRRF. The number of days of overwear beyond MRRF was calculated as the difference between the reported and recommended schedule. Compliant patients who discarded their CLs according to, or earlier than, MRRF were recorded as having no days of overwear. Analyses of compliance with MRRF as the percentage of patients compliant with MRRF and the average number of days of overwear beyond MRRF are presented below. Values for average number of days of overwear beyond MRRF are conditional on noncompliance; overall average days of overwear for each group can be computed by multiplying average days overwear conditional on noncompliance by the fraction of noncompliant patients within that group.

Data collection, storage, and condentiality for the current study

As mentioned above, the data used in this study were extracted from our earlier report on the prevalence of CLrelated complications.8 Only the SCL data from the earlier study were used. Eyes using rigid gas-permeable lenses, hybrid lenses such as SynergEyes (SynergEyes, Inc.; Carlsbad, California), or soft lenses as piggybacks were all excluded from the data. Subjects age, sex, lens material, frequency of CL disposal, care solution, prescription, and description of complications were extracted to a password-protected computer and stored as described in the previous study for

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Table 1 Compliance and complications by demographics Observation Overall Sex Female Male Age 18-19 20-29 30-39 40-49 50+ Prescription High myopia Medium myopia Low myopia Hyperopia Replacement Modality Daily Biweekly Monthly Quarterly Annually Soft Contact Lens Type Non-silicone Silicone Both Lens Solution Type Multipurpose Hydrogen peroxide 271 206 65 24 182 40 14 11 77 97 80 6 21 198 41 7 3 140 127 4 184 31 Percent compliant 65% 65% 63% 67% 62% 68% 79% 73% 62% 63% 64% 67% 86% 59% 78% 86% 100% 60% 69% 75% 61% 81% 95% Condence interval * [62%, 67%] [62%, 68%] [57%, 69%] [57%, [58%, [60%, [68%, [59%, [57%, [58%, [58%, [47%, [78%, [55%, [72%, [72%, 76%] 66%] 75%] 90%] 86%] 68%] 68%] 69%] 86%] 93%] 62%] 85%] 99%]

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Average complications per eye 0.93 0.87 1.11 0.92 0.98 0.83 0.96 0.45 0.96 1.08 0.68 1.17 0.67 0.94 0.85 1.07 2.33 1.02 0.83 0.75 0.95 0.82

Average days overwear 32.80 27.87 47.60 62.75 32.89 14.69 55.67 6.50 18.91 45.97 31.81 11.50 19.67 32.62 35.00 92.50

[56%, 64%] [65%, 73%] [53%, 97%] [58%, 65%] [74%, 88%]

44.80 16.00 16.00 27.70 12.92

Note. Some observations are missing or are for omitted categories, so totals across all categories do not match the overall total for all demographics and lens/solution type. Bolded groups indicate that we can reject equality with at least 95% condence. * 95% Condence interval calculated as 6 1.96 times the standard error of the mean. Among patients who are noncompliant.

When reporting complication rates, because we treat the patient as the unit of observation, we took the average number of complications between a patients CL-wearing eyes. If the patient only wore a CL in one eye, we used the number of complications in that eye. If the patient wore CLs in both eyes, we use a simple average of the number of complications in both eyes. As a result, a patient could have 0.5 average complications per eye if there was a complication in only 1 of their 2 CL-wearing eyes. This study was approved by the UCLA Institutional Review Board with informed consent provided by all patients included in the study.

Results
Demographics
Among the 572 patients reported in our previous study,8 271 were SCL users who met our inclusion criteria. Of the patients in this sample, 65 (24%) were men and 206

(76%) were women. Patients ages ranged from 18 to 70 with an average age of 27 and a median age of 25. Out of the 271 SCL wearers studied, 140 patients wore nonsilicone hydrogels, 127 patients wore silicone hydrogels, and 4 wore both (one in each eye). CL-replacement schedules for these patients were daily replacement (7.8%), 2-week replacement (73.1%), monthly replacement (15.1%), quarterly replacement (2.6%), yearly replacement (1.1%), and mixed replacement (0.4%). Mixed refers to individuals with different replacement schedules for their left and right eyes. Of the 268 patients who presented for a single recorded reason, 81.3% were for a CL examination, 16.0% for a CL progress evaluation, 1.5% for a CL retting, 0.4% for red eye, and 0.8% for other/did not report. All patients were existing CL wearers. Diagnoses for these patients included myopia (96%), astigmatism (51%), presbyopia (7%), hyperopia (2%), and keratoconus (1%). Penetrating keratoplasty, aphakia, and other conditions not listed above occurred in less than 0.5% of the study population.

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601 overwear beyond MRRF). We grouped patients ages 50 and older together because only 11 patients in our sample were older than 50, so the number in any decade of life over 50 was very small. We found that the average days of overwear beyond MRRF by noncompliant patients is statistically signicantly different across age groups (P 5 0.02), but the median days of overwear by noncompliant patients is only marginally signicant (P 5 0.09), and the average lens replacement compliance to MRRF is not statistically signicantly different across age groups (P 5 0.75). Post-hoc analysis found that average days of overwear is signicantly different between patients in their 20s versus 30s (P 5 0.03) and between patients in their 20s versus 50s (P , 0.01), and marginally different between patients in their 40s versus 50s (P 5 0.07) and between patients in their 30s versus 50s (P 5 0.10). When analyzing the SCL-related average complications per eye for different age groups, the average number of complications was 0.92 6 0.83 for 18- to19-year-olds, 0.98 6 0.84 for 20- to 29-year-olds, 0.83 6 0.79 for 30- to 39-year-olds, 0.96 6 1.05 for 40- to 49-year-olds, and 0.45 6 0.69 for individuals ages 50 and older. We found that both average and median complications per eye are not statistically signicantly different across age groups (P 5 0.16 for average; P 5 0.35 for median).

Overall: compliance rate, days of overwear, and complications

The 271 patients wearing SCLs had an overall rate of compliance with MRRF of 65%. Noncompliant patients averaged 33 days of overwear beyond MRRF (see Table 1). The overall average number of complications among the SCL patients was 0.93 6 0.83 complications per eye. The modal and median numbers of complications per eye per patient were both 1. Thirty-six percent of the patients had less than 1 complication per eye (35% had no complications in any CL-wearing eye and 1% had CLs in both eyes but a complication in only one eye), 39% had 1 complication per eye, and 25% had more than 1 complication per eye. The maximum number of average complications per eye was 3. The most common complications were neovascularization (39%), GPC (36%), and papillae (10%).

Sex: compliance rate, days of overwear, and complications

When divided by sex, 63% of men were compliant with MRRF with an average for noncompliant patients of 48 days of overwear beyond MRRF, corresponding to 419% of the recommended schedule. Sixty-ve percent of women were compliant with MRRF with an average for noncompliant patients of 28 days of overwear beyond MRRF, corresponding to 224% of the recommended schedule. Neither difference was statistically signicant (P 5 0.77 for compliance to MRRF and P 5 0.26 for days of overwear beyond MRRF). There was not a statistically signicant difference in the median days of overwear (P 5 0.26) for noncompliant patients. When comparing the complication rate difference between sexes, men had a statistically signicantly (P 5 0.049) higher average rate of complications (1.11 complications per eye 6 0.85) compared to that of women (0.87 complications per eye 6 0.83), although the difference in medians was only marginally statistically signicantly different (P 5 0.054).

Refractive errors: compliance rate, days of overwear, and complications

To evaluate refractive error, we grouped patients by their degree of refractive error. Refractive errors ranged from 17.00 diopters (D) to 117.00 D. Patients are categorized as having high myopia if at least 1 of their eyes had a refractive error of 6.00 D or more. Patients are classied as having moderate myopia if at least 1 of their eyes had a refractive error of 3.00 D or more and they did not fall into the high myopia category. Patients are classied as having low myopia if at least 1 of their eyes is myopic but does not fall into the medium or high myopia category. Patients are classied as having hyperopia if both of their eyes are hyperopic (due to small sample size, we did not further differentiate among hyperopic patients). Based on this classication scheme, 30% of patients were high myopes, 37% of patients were moderate myopes, 31% of patients were low myopes, and 2% of patients were hyperopes. For hyperopic patients, average compliance with MRRF was 67% (with noncompliant patients having an average of 12 days of wear beyond MRRF). For high myopic patients, average compliance with MRRF was 62% (with an average of 19 days of wear beyond MRRF for noncompliant patients). Average compliance with MRRF for moderate myopic patients was 63% (with an average of 46 days of wear beyond MRRF for noncompliant patients). Low myopic patients had an average compliance with MRRF of 64% (with an average of 32 days of wear beyond MRRF for noncompliant patients). Average compliance with

Age: compliance rate, days of overwear, and complications

We found an insignicant (P 5 0.19) effect of age (as a continuous variable) on compliance to MRRF based on a logit regression of compliance on age. When broken down by decade of life, the rate of compliance was 67% for 18- to 19-year-olds (average of 63 days of overwear beyond MRRF for noncompliant patients), 62% for 20- to 29-yearolds (average of 33 days of overwear beyond MRRF for noncompliant patients), 68% for 30- to 39-year-olds (average of 15 days of overwear beyond MRRF for noncompliant patients), 79% for 40- to 49-year-olds (average of 56 days of overwear beyond MRRF for noncompliant patients), and 73% for patients ages 50 and older (average of 7 days of

602 MRRF (P . 0.99), noncompliant patients average overwear days beyond MRRF (P 5 0.16), and noncompliant patients median days of overwear (P 5 0.49) are not statistically signicantly different between the categories of refractive error. As an alternative test of whether refractive error measured as a continuous variable was signicantly related to compliance, we performed a logit regression of compliance on the patients largest (in absolute value) refractive error. This regression found a positive but insignicant (P 5 0.54) effect of the patients largest refractive error on compliance. When comparing complication rates by the patients refractive errors, the average number of complications per eye was 0.96 6 0.92 for high myopic patients, 1.08 6 0.88 for moderate myopic patients, 0.68 6 0.69 for low myopic patients, and 1.17 6 0.75 for hyperopic patients. The average (P , 0.01) and median (p 5 0.03) number of complications per eye are statistically signicantly different across refractive error groups. Of the pairwise comparisons between groups, only 2 differences were signicant; low myopia was signicantly different from both medium myopia (P , 0.01) and high myopia (P 5 0.03). As an alternative test of whether refractive error measured as a continuous variable was signicantly related to the average number of complications per eye, we performed a WLS regression of complications per eye on the patients largest (in absolute value) refractive errors. This regression found a positive but insignicant (P 5 0.15) effect of refractive error on average complications per eye.

Optometry, Vol 81, No 11, November 2010 with annual replacement were compliant, this group was excluded from analysis. Because the mixed group had a sample size of one, it was also excluded from analysis.) Post-hoc pairwise comparisons found that patients with fortnightly replacement schedules are signicantly less compliant than daily wear patients (P 5 0.02) or monthly wear patients (P 5 0.02). Patients utilizing the daily scheduled replacement CL modality had an average of 0.67 6 0.65 complications per eye. Those who were scheduled to replace their SCLs every 2 weeks had an average of 0.94 6 0.85 complications per eye. Patients with monthly scheduled replacement CLs had an average of 0.85 6 0.78 complications per eye. Patients with quarterly scheduled replacement CLs had an average of 1.07 6 0.73 complications per eye. Finally, patients using SCL with yearly scheduled replacement had an average of 2.33 6 0.58 complications per eye. The average number of complications per eye was statistically signicantly different (P , 0.01) across replacement modalities, but the median number of complications per eye was only marginally signicantly different (P 5 0.10) across modalities. This is being driven by the much higher complication rate in the yearly replacement patient population, which consisted of just 3 patients. Ignoring comparisons with yearly replacement, of the post-hoc pairwise comparisons of complications per eye for different replacement modalities only 1 pair, daily and biweekly replacement, was even marginally statistically signicantly different (P 5 0.08). As shown in Table 2, for all replacement modalities the 3 most common complications were neovascularization, GPC, and papillae.

CL replacement modality: compliance rate, days of overwear, and complications

When comparing the rate of compliance with MRRF across different SCL groups, the percentage of compliance with MRRF was 86% for daily replacement with noncompliant patients averaging 20 days of wear beyond MRRF, 59% for 2-week replacement with noncompliant patients averaging 33 days of wear beyond MRRF, 78% for monthly replacement with noncompliant patients averaging 35 days of wear beyond MRRF, 86% for quarterly replacement with noncompliant patients averaging 93 days of wear beyond MRRF, and 100% compliance for annual replacement. Although the number of days overwear beyond MRRF may seem higher in the groups with longer recommended replacement schedules, the number of days overwear beyond MRRF is a smaller fraction of the actual recommended schedule (2,000% for daily, over 200% for fortnightly, and just over 100% for monthly and quarterly). Average compliance with MRRF (P , 0.01) and noncompliant patients median days overwear beyond MRRF (P 5 0.04) are statistically signicantly different across CL replacement schedule groups, but average overwear days beyond MRRF for noncompliant patients are not statistically signicantly different (P 5 0.36). (Because all patients

CL type: compliance rate, days of overwear, and complications

Of the 140 patients wearing nonsilicone hydrogels, 60% were compliant with MRRF (with an average of 45 days of overwear beyond MRRF for noncompliant patients), whereas the 127 patients wearing silicone hydrogels had a rate of 69% compliance with MRRF (with an average of 16 days of overwear beyond MRRF for noncompliant patients). For the 4 patients wearing both, 75% were compliant with MRRF (with an average of 16 days of overwear beyond MRRF for noncompliant patients). Average compliance with MRRF (P 5 0.26) is not statistically signicantly different across SCL material types. Noncompliant patients average overwear days beyond MRRF (P 5 0.01) are statistically signicantly different across SCL material types although the median overwear days (P 5 0.16) are not. (Analysis of averages omits patients using both lens types, as there was only one such noncompliant patient in our sample.) Eyes with silicone hydrogels had a complication rate (0.83 6 0.77) that was marginally signicantly (P 5 0.06) lower than that of nonsilicone hydrogel SCLs (1.02 6 0.89).

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Table 2

Clinical Research
Detailed prevalence of complications by wear schedule Average occurrence if scheduled replacement interval is

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Category Conjunctiva Conjunctiva Conjunctiva Conjunctiva Conjunctiva Conjunctiva Cornea Cornea Cornea Cornea Cornea Cornea Cornea Cornea Cornea Cornea

Complication GPC Papillae Conjunctival injection Chemosis Conjuctiva - other Follicles Neovascularization Corneal - other Diffused SPK Inltrates Localized SPK SEAL Corneal Ulcer Corneal Abrasion Corneal Edema 3-9 Staining

Daily 24% 14% 0% 0% 0% 0% 29% 0% 0% 0% 0% 0% 0% 0% 0% 0%

Biweekly 38% 10% 3% 2% 1% 0% 38% 1% 1% 1% 1% 0% 0% 0% 0% 0%

Monthly 32% 7% 2% 0% 0% 0% 43% 1% 0% 0% 0% 0% 0% 0% 0% 0%

Quarterly 29% 14% 0% 0% 0% 0% 64% 0% 0% 0% 0% 0% 0% 0% 0% 0%

Annually 67% 33% 33% 0% 0% 0% 100% 0% 0% 0% 0% 0% 0% 0% 0% 0%

Overall 36% 10% 3% 1% 1% 0% 39% 1% 1% 1% 0% 0% 0% 0% 0% 0%

Note. Values are rounded to the nearest percent. Values greater than 0 but less than 0.5% occurred for SEAL, Corneal Ulcer, and Corneal Abrasion under Biweekly replacement interval, and for Localized SPK, SEAL, Corneal Ulcer, and Corneal Abrasion under Overall. GPC 5 giant papillary conjunctivitis, SPK 5 supercial punctate keratitis, SEAL 5 superior epithelial arcuate lesion.

CL solutions: compliance rate, days of overwear, and complications

Patients utilizing multipurpose CL solutions as their care system disposed their CLs with regard to MRRF with a compliance rate of 61%. Patients who used hydrogen peroxide CL solutions had a statistically higher rate of CL compliance with MRRF (81%; P 5 0.04). Noncompliant patients using multipurpose CL solutions had an average of 28 days of CL overwear beyond MRRF, which was statistically signicantly different (P 5 0.02) from patients utilizing hydrogen peroxide solution, who had a lower average of 13 days of overwear beyond MRRF (see Table 1). Patients utilizing multipurpose CL solutions as their care system had a number of complications per eye averaging 0.95 6 0.83. This was not statistically signicantly different (P 5 0.42) from patients utilizing hydrogen peroxide CL solutions, whose number of complications per eye averaged 0.82 6 0.78. The median number of complications per eye was also not statistically signicantly different between multipurpose and hydrogen peroxide CL solution users (P 5 0.47).

Patients who were compliant to MRRF had an average of 0.88 6 0.83 complications per eye. Patients who replaced their CLs at an interval greater than the recommended schedule, and up to twice the MRRF, had an average of 1.02 6 0.86 complications per eye. Patients who replaced their CLs at an interval greater than twice, and up to 3 times longer than MRRF, had an average of 0.88 6 0.77 complications, the same average as fully compliant patients. Patients who were the least compliant, replacing their CLs at an interval more than 3 times beyond MRRF, had the greatest average number of complications, 1.29 6 0.92 per eye. Although equality of average (P 5 0.26) and median (P 5 0.26) complications across groups could not be rejected at typical signicance levels, a pairwise comparison did nd that average complications for compliant patients was marginally signicantly different than
2 1.8 1.6 1.4 1.2 1 0.8 0.6

Relationship between compliance and complications

Figure 1 displays the average number of complications by degree of compliance to discarding CLs according to MRRF, with a 95% condence interval around the average.

0.4 0.2 0 Compliant 1 2x Recommended schedule 2 3x Recommended schedule >3x Recommended schedule

Figure 1 Complications by degree of overwear average and 95% condence interval.

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Table 3

Optometry, Vol 81, No 11, November 2010

Tobit regression analysis effect of compliance on average complications per eye [1] Avg. Complications Per Eye 0.003 [0.066] [2] Avg. Complications Per Eye 0.003 [0.065] 0.017 [0.580] 0.003 [0.100] 0.009 [0.402] 0.009 [0.490] 0.0596 All patients 271 [3] Avg. Complications Per Eye

Dependent variable Coefcient on days of overwear [P-value] Coefcient on days of overwear for daily-replacement lenses [P-value] Coefcient on days of overwear for fortnightly-replacement lenses [P-value] Coefcient on days of overwear for monthly-replacement lenses [P-value] Coefcient on days of overwear for quarterly-replacement lenses [P-value] Pseudo-R2 Sample includes Sample size

0.0603 All patients 271

0.0901 Noncompliant patients 96

Note. Regression equations also included explanatory variables to control for age (decade of life), sex (male/female), prescription (e.g., high myopia, medium myopia), replacement schedule (e.g., daily, biweekly), lens type (silicone, non-silicone, or both), and care solution (multipurpose or hydrogen peroxide).

average complications for patients who replace their CLs at an interval more than 3 times beyond MRRF (P 5 0.07). We nd a positive and marginally statistically signicant (P 5 0.07) correlation of 0.11 between average number of complications per eye and days of overwear beyond MRRF for noncompliant patients. We also nd that average complications per eye is lower but not signicantly different (P 5 0.18) for compliant patients relative to noncompliant patients, and that the median number of complications per eye is also lower but not signicantly different (P 5 0.17) for compliant patients relative to noncompliant patients. To isolate the effect of compliance to MRRF on the complication rate, we used multivariate regression analysis. The complication rate was measured both in terms of average complications per eye and in terms of having the top 4 specic complications (GPC, papillae, neovascularization, and injection). In addition to compliance to MRRF

or days of overwear beyond MRRF, the model simultaneously took into account age (18 to 19, 20 to 29, 30 to 39, 40 to 49, and 50 and older), sex (male or female), prescription (high myopia, moderate myopia, low myopia, and hyperopia), replacement schedule (daily, 2 weeks, monthly, quarterly, or annually), lens type (silicone, nonsilicone, or both), and care solution (multipurpose or hydrogen peroxide). For brevity, we do not report the results of these additional explanatory variables but only report coefcient estimates related to compliance. The unit of observation in these regressions was a patient. Table 3 reports the results of regressions of average complications per eye on measures of compliance to MRRF and the explanatory variables outlined above. Because patients cannot have fewer than zero complications, the outcome variable is censored at zero and we therefore use Tobit regression (also known as censored regression). The rst column reports

Table 4

Logit regression analysis effect of compliance on specic complications GPC Papillae -0.045 [0.933] 0.2255 All patients 266 Neovasc. -0.377 [0.193] 0.0903 All patients 267 Injection -0.114 [0.896] 0.0793 All patients 128

Coefcient on compliance to MRRF [P-value] Pseudo-R2 Sample includes Sample size

-0.334 [0.257] 0.1107 All patients 264

Note. Regression equations also included explanatory variables to control for age (decade of life), sex (male/female), prescription (e.g., high myopia, medium myopia), replacement schedule (e.g., daily, biweekly), lens type (silicone, non-silicone, or both), and care solution (multipurpose or hydrogen peroxide). GPC 5 giant papillary conjunctivitis; MRRF 5 manufacturers recommended replacement frequency.

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Clinical Research

605 Moreover, although our study shows no signicant differences in the average number complications among the various age groups, McNally et al.17 found that patients younger than 30 years old had higher rates of microbial keratitis. We also nd that the degree of refractive error did not have a statistically signicant effect on patient compliance or number of days of CL overwear. Low myopes, however, had signicantly fewer complications compared with medium and high myopes. This could be because of the greater lens thickness used to treat higher myopia. Alternatively, this could be because low myopes may be less dependent on CLs and therefore simply wear their CLs for shorter durations than those with higher prescriptions. Regardless of the underlying cause, this nding is consistent with that of Zadnik et al.18 that highly ametropic patients (65.00 D or greater) have more corneal staining and corneal neovascularization. Our ndings show a similar overall compliance rate (averaging 65%) to that found by Dumbleton et al.5 of 60%, although our estimate is statistically signicantly different from 60%. Interestingly, in our study, annual replacement CL wearers were the most compliant, and quarterly replacement CL wearers were also highly compliant. The small patient population combined with a larger tolerability of number of days to still be considered compliant may be skewing our results upward, and this could explain the difference between our results and those of Dumbleton et al.5 More signicantly, and consistent with Dumbleton et al.,5 we nd that 1-day disposable and 1-month disposable CL wearers were more compliant with MRRF than the fortnightly disposable CL wearers. Our 1-day disposable CL wearers were 86% compliant to MRRF, which is similar to the 85% compliance rate to MRRF in Dumbleton et al.5 Our 1-month disposable CL wearers had a 78% compliance rate to MRRF compared with 71% in Dumbleton et al.5 Our 2-week disposable CL patients had a signicantly higher compliance rate of 59% compared with that of Dumbleton et al.,5 which nds a 41% compliance rate for this group. As expected, and consistent with the ndings of Solomon et al.19 and Suchecki et al.,20 daily disposable CLs were found to be associated with the lowest rate of complications. Interestingly, Dart et al.21 found a higher rate of microbial keratitis with daily disposable CLs. We nd that GPC and neovascularization are the most common SCL wear-related complications. The rate of GPC among individuals with daily replacement schedules may be high in our study because such patients may have been retted with daily disposable CLs to treat GPC. Annual replacement CL patients had the highest rate of CL wear-related complications, including corneal neovascularization, GPC, papillae, and conjunctival injection. Relative to other studies, the rate of compliance for patients with annual replacement CLs appears high. We believe that this value may be skewed upward in our sample because of several possible factors, including that our sample of patients with an annual replacement schedule

the results of a specication in which the measure of compliance is days of overwear beyond MRRF. There is a small and marginally signicant (P 5 0.066) effect of each day of overwear. Based on the estimated coefcient, it would take a 336day shift in overwear to induce, on average, an additional complication per eye. To capture the marginal effect of each day of overwear beyond MRRF for noncompliant patients, in column 2 we restricted our sample to only those patients that were noncompliant to MRRF. The effect is slightly larger than that in column 1, although not visible because of rounding, and only marginally signicant (P 5 0.065). Based on the estimated coefcient from column 2, it would take a 330-day shift in overwear to induce, on average, an additional complication per eye. Column 3 repeats the specication from column 1, with the addition of interactions between replacement modality and days of overwear. This allows each day of overwear to have a different effect, depending on the MRRF. (A regression using the same specication restricted to noncompliant patients failed to converge and is therefore not reported here.) Although the effect of a day of overwear is not statistically signicantly different across MRRF, the point estimate is larger for daily disposables than for other replacement modalities. Based on this estimate, it would only take a 60-day shift in overwear for daily disposables to induce, on average, an additional complication per eye. Table 4 reports the results of logistic (or logit) regressions of a particular complication on a binary variable measuring compliance to MRRF as well as the explanatory variables described above. For each of the top 4 complications, the simple binary measure of compliance with MRRF is associated with a statistically insignicant reduction in the likelihood of having that complication.

Discussion
Similar to Dumbleton et al.,5 we found that there is no difference between men and women with regard to compliance to MRRF. We also found no difference in terms of days of CL overwear beyond MRRF between men and women. Interestingly, however, we found men have a higher rate of complications. The cause for higher rates of complication in men compared to that of women is still speculative, given equal compliance rates. Future studies can evaluate what factors are causing the difference in complications between men and women in both silicone and nonsilicone lens modalities. Dumbleton et al.5 found that noncompliant patients were younger, on average, than compliant patients. Because their study did not separate out compliance by age groups, our estimates of compliance are not directly comparable. Although our study does not show a statistically signicant logistic relationship between age and compliance, or a difference in compliance to MRRF among the various age groups, we do nd that average days of overwear among noncompliant patients is signicantly different.

606 may be too small to be representative, and that the unit of measurement for annual replacement is 1 year, which may lead to the patient being recorded as compliant even if the patient replaces the contact lenses several months beyond MRRF. Compared with patients wearing silicone hydrogels, patients wearing nonsilicone hydrogels tend to overwear their CLs 3 to 4 times longer on average beyond MRRF. Corresponding to the longer average overwear beyond MRRF, nonsilicone CLs had marginally signicant higher numbers of CL-related complications compared with that of silicone CL wearers. This was contrary to our hypothesis that decreased symptoms from silicone SCLs would spur overwear. We are not aware of any other study that compares the compliance of silicone with that of nonsilicone wearers. Our study shows a marginally statistically signicant increase in complications associated with days of CL overwear beyond MRRF. Although compliant and noncompliant patients did not have signicantly different average numbers of complications for the whole sample, patients who replaced their CLs more than 3 times over MRRF were found to have marginally signicantly more average complications than compliant patients. This is consistent with our nding that days of overwear are marginally positively associated with more complications. Although compliance is important in the sense that it produces the minimum amount of overwear, the number of days that the patient exceeds the recommended replacement schedule is found to be a key factor. This demonstrates that even patients who are not fully compliant can still reduce their rate of CL wearrelated complications by reducing the number of days that they overwear their CLs beyond MRRF. This underlines the importance of educating patients to prevent ocular complications by being compliant and adhering to the MRRF. Patients using hydrogen peroxidebased cleaning solutions as opposed to multipurpose solutions were more compliant in terms of replacing their CLs according to MRRF and not overwearing them as long beyond MRRF if noncompliant. The increased compliance may be driven by the fact that hydrogen peroxide solutions require more attention when disinfecting the lenses to prevent hydrogen peroxide corneal burns. Additionally, given that use of hydrogen peroxidebased cleaning solutions are associated with lower rates of corneal staining and ocular inammation compared with multipurpose solutions,22 patients in our sample were generally prescribed hydrogen peroxidebased solutions because of current or past CL-related complications such as GPC or previous eye infections noted. Patient education as well as CL-related complication history may have driven these patients to be more compliant than the asymptomatic patients. In our study, there was no difference in complication rates between those using multipurpose solutions versus hydrogen peroxide solutions. None of our patients presented with acanthamoeba or fusarium keratitis, as was reported during the recalls of Complete Moisture Plus (Abbott Medical

Optometry, Vol 81, No 11, November 2010 Optics [formerly Advanced Medical Optics]; Abbott Park, Illinois) and Renu MoistureLoc (Bausch and Lomb; Rochester, New York). Because this was an observational study, not a controlled experiment, we were not able to choose whether patients would be compliant. As a result, complications and compliance are likely to be endogenously related. Those patients who are naturally more prone to complications will be spurred toward greater compliance, whereas patients who are more robust to complications will be tempted to relax their compliance. In addition, because the measure of compliance to MRRF is self-reported by the patient during an examination, some of the reported replacement data may be biased toward higher compliance. As a result of these factors, it is possible that the true effect of compliance on complications is greater than that reported here. The endogeneity between complications and compliance may have the effect that lens materials or care solutions that cause fewer complications encourage overwear beyond MRRF because each additional day of overwear is less damaging. The coefcients from the third column of Table 3 are broadly consistent with this idea. Daily disposables have the largest coefcient, although none of the coefcients are estimated with enough precision to say that the effect of overwear from 1 replacement modality is signicantly different from any other replacement modality.

Conclusion
We nd noncompliance (specically overwear of SCLs) broadly present across demographic groups and patient types. Noncompliance with regard to discarding CLs according to MRRF is highest with patients using 2-week disposable CLs and patients using multipurpose solutions. The severity of noncompliance as measured by days of CL overwear beyond MRRF is highest with teenagers, patients wearing 2-week disposable CLs, and patients wearing nonsilicone hydrogels. Our ndings suggest that prolonged overwear of CLs beyond the MRRF is associated with ocular complications, which can be further evaluated in future studies. Our study should help practitioners identify which patient groups are likely to be less compliant. Although not evaluated in this study, motivations for noncompliance can include cost, lack of patient education, and asymptomatic CL-related complications. Future studies using controlled experiments should be able to ascertain causal effects that we are only able to attribute to association. Our results support the idea that patient education to encourage compliance with recommended replacement schedules is an important part of every eye examination.

Acknowledgment
Drs. J. Forister and Chung were supported, in part, by an educational grant from The Vision Care Institute LLC, a

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11. Weinstock F. Study shows preference for new silicone hydrogel contact lens. Refractive Eyecare 2005;9:24. 12. Long B, McNally J. The clinical performance of a silicone hydrogel lens for daily wear in an Asian population. Eye & Contact Lens 2006;32:65-71. 13. Donshik PC, Ehler WH, Anderson LD, et al. Strategies to better engage, educate, and empower patient compliance and safe lens wear: compliance: what we know, what we do not know, and what we need to know. Eye & Contact Lens 2007;33(6):430-3. 14. Efron N. Grading scales for contact lens complications. Ophthal Physiol Opt 1998;18(2):182-6. 15. Thompson T. Tylers quarterly soft contact lens parameter guide. 2008;25(4):4-15. 16. Neter J, Kutner MH, Nachtsheim CJ, et al. Applied linear statistical models, 4th ed. Chicago: WCB/McGraw-Hill; 1996:768-9. 17. McNally JJ, Chalmers RL, McKenney CD, et al. Risk factors for corneal inltrative events with 30 night continuous wear of silicone hydrogel lenses. Eye & Contact Lens 2003;29(1S):S153-6. 18. Zadnik K, Mutti DO, Cutter GR, et al. The effect of degree of refractive error on hydrogel contact lens-induced complications and patient self-management behaviors. Optom Vis Sci 2001;78(9): 652-6. 19. Solomon OD, Freeman MI, Boshnick EL, et al. A 3-year prospective study of the clinical performance of daily disposable contact lenses compared with frequent replacement and conventional daily wear contact lenses. CLAO J 1996;22(4):250-7. 20. Suchecki JK, Ehlers WH, Donshik PC. A comparison of contact lens complications in various daily wear modalities. CLAO J 2000;26(4): 204-13. 21. Dart JK, Radford CF, Minassian D, et al. Risk factors for microbial keratitis with contemporary contact lenses: a case control study. Ophthalmology 2008;115:1647-54. 22. Carnt N, Jalbert I, Stretton S, et al. Solution toxicity in soft contact lens daily wear is associated with corneal inammation. Optom Vision Sci 2007;84(4):309-15.

Johnson & Johnson company. Dr. Weissman was supported, in part, by an educational grant from Marvin Smotrich, O.D.

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