Risk factors for moderate and severe microbial keratitis in daily wear contact lens users

Objective: To establish risk factors for moderate and severe microbial keratitis among daily contact lens (CL) wearers in Australia. Design: A prospective, 12-month, population-based, case-control study. Participants: New cases of moderate and severe microbial keratitis in daily wear CL users presenting in Australia over a 12-month period were identified through surveillance of all ophthalmic practitioners. Case detection was augmented by record audits at major ophthalmic centers. Controls were users of daily wear CLs in the community identified using a national telephone survey. Testing: Cases and controls were interviewed by telephone to determine subject demographics and CL wear history. Multiple binary logistic regression was used to determine independent risk factors and univariate population attributable risk percentage (PAR%) was estimated for each risk factor.; Main Outcome Measures: Independent risk factors, relative risk (with 95% confidence intervals [CIs]), and PAR%. Results: There were 90 eligible moderate and severe cases related to daily wear of CLs reported during the study period. We identified 1090 community controls using daily wear CLs. Independent risk factors for moderate and severe keratitis while adjusting for age, gender, and lens material type included poor storage case hygiene 6.4× (95% CI, 1.9-21.8; PAR, 49%), infrequent storage case replacement 5.4× (95% CI, 1.5-18.9; PAR, 27%), solution type 7.2× (95% CI, 2.3-22.5; PAR, 35%), occasional overnight lens use (<1 night per week) 6.5× (95% CI, 1.3-31.7; PAR, 23%), high socioeconomic status 4.1× (95% CI, 1.2-14.4; PAR, 31%), and smoking 3.7× (95% CI, 1.1-12.8; PAR, 31%). Conclusions: Moderate and severe microbial keratitis associated with daily use of CLs was independently associated with factors likely to cause contamination of CL storage cases (frequency of storage case replacement, hygiene, and solution type). Other factors included occasional overnight use of CLs, smoking, and socioeconomic class. Disease load may be considerably reduced by attention to modifiable risk factors related to CL storage case practice.

Comfort and adaptation to silicone hydrogel lenses for daily wear

Objectives. To investigate initial comfort and adaptation of currently successful low oxygen transmissibility soft lens wearers refitted with silicone hydrogel (SH) lenses for daily wear.

Methods. Fifty-five subjects were enrolled in a subject-masked 5-month clinical trial in which they wore 5 SH lenses in a randomized, crossover design. Comfort, burning, and dryness were rated on scales of 0 to 100 immediately on insertion and the time for lens settling was recorded. Symptoms were then rated at various times, using BlackBerry wireless communication devices (Research in Motion, Waterloo, Canada), during the day for 2 cycles of 2 weeks wear for each lens type.

Results. Comfort immediately on insertion varied between lens types (P=0.002). All lens types were reported by the subjects to have settled within 30 to 45 sec of insertion (P=0.14) and settled comfort was greater than comfort immediately on insertion (P<0.001). Comfort within the first hour of wear also varied between lens types (P=0.02). Comfort during the day decreased significantly for all lenses (P=0.001), but there was no difference between lenses (P=0.19) and no effect of lens age (P=0.15). The wearing times were greater with the SH lenses than the habitual lenses worn before study commencement (P=0.001). Overall performance of the lenses after 4 weeks was high, with no difference between lenses (P=0.45).

Conclusions. Initial comfort and adaptation to all SH lenses were good and no differences in the overall ratings were found between the 5 SH lenses investigated. Decreased comfort was noted later in the day with all lens types, but longer wearing times were reported with the SH lenses than previous hydroxyethyl methacrylate-based lenses.

Clinical performance of a new silicone hydrogel contact lens over 6 months of extended wear

Purpose: Silicone hydrogel contact lenses (CLs) are becoming increasingly popular for daily wear (DW), extended wear (EW) and continuous wear (CW), due to their higher oxygen transmissibility compared to hydrogel CLs. The aim of this study was to investigate the clinical and subjective performance of asmofilcon A (Menicon Co., Ltd), a new surface treated silicone hydrogel CL, during 6-night EW over 6 months (M). Methods: A prospective, randomised, single-masked, monadic study was conducted. N=60 experienced DW soft CL wearers were randomly assigned to wear either asmofilcon A (test: Dk=129, water content (WC)=40%, Nanogloss surface treatment) or senofilcon A (control: Dk=103, WC=38%, PVP internal wetting agent, Vistakon, Johnson & Johnson Vision Care) CLs bilaterally for 6 M on an EW basis. A PHMB-preserved solution (Menicon Co., Ltd) was dispensed for CL care. Evaluations were conducted at CL delivery and after 1 week (W), 4 W, 3 M and 6 M of EW. At each visit, a range of objective and subjective clinical performance measures were assessed. Results: N=50 subjects (83%) successfully completed the study, with the majority of discontinuations due to loss to follow-up (n=3) or moving away/travel (n=5). N=2 subjects experienced adverse events; n=1 unilateral red eye with asmofilcon A and n=1 asymptomatic infiltrate with senofilcon A. There were no significant differences in high or low contrast distance visual acuity (HCDVA or LCDVA) between asmofilcon A and senofilcon A; however, LCDVA decreased significantly over time with both CL types (p<0.05). The two CL types did not vary significantly with respect to any of the objective and subjective measures assessed (p>0.05); CL fitting characteristics and CL surface measurements were very similar and mean bulbar and limbal redness measures were always less than grade 1.0. Superior palpebral conjunctival injection showed a statistically, but not clinically, significant increase over time with both CL types (p<0.05). Corneal staining did not vary significantly between asmofilcon A and senofilcon A (p>0.05), with low median gradings of less than 0.5 observed for all areas assessed. There were no solution-related staining reactions observed with either CL type. The asmofilcon A and senofilcon A CLs were both rated highly with respect to overall comfort, with medians of 14 or 15 hours of comfortable lens wearing time per day reported at each of the study visits (p>0.05). Conclusions: Over 6 months of EW, the asmofilcon A and senofilcon A CLs performed in a similar manner with respect to visual acuity, ocular health and CL performance measures. Some changes over time were observed with both CL types, including reduced LCDVA and increased superior palpebral injection, which warrant further investigation in longer-term EW studies. Asmofilcon A appeared to be equivalent in performance to senofilcon A.

Determinants of the frequency of contact lens wear

Objectives To characterize and discover the determinants of the frequency of wear (FOW) of contact lenses. Methods Survey forms were sent to contact lens fitters in up to 40 countries between January and March every year for 5 consecutive years (2007–2011). Practitioners were asked to record data relating to the first 10 contact lens fits or refits performed after receiving the survey form. Only data for daily wear lens fits were analyzed. Results Data were collected in relation to 74,510 and 9,014 soft and rigid lens fits, respectively. Overall, FOW was 5.9±1.7 days per week (DPW). When considering the proportion of lenses worn between one to seven DPW, the distribution for rigid lenses is skewed toward full-time wear (7 DPW), whereas the distribution for soft daily disposable lenses is perhaps bimodal, with large and small peaks at seven and two DPW, respectively. There is a significant variation in FOW among nations (P<0.0001), ranging from 6.8±1.0 DPW in Greece to 5.1±2.5 DPW in Kuwait. For soft lenses, FOW increases with decreasing age. Females (6.0±1.6 DPW) wear lenses more frequently than males (5.8±1.7 DPW) (P=0.0002). FOW is greater among those wearing presbyopic corrections (6.1±1.4 DPW) compared with spherical (5.9±1.7 DPW) and toric (5.9±1.6 DPW) designs (P<0.0001). FOW with hydrogel peroxide systems (6.4±1.1 DPW) was greater than that with multipurpose systems (6.2±1.3 DPW) (P<0.0001). Conclusions Numerous demographic and contact lens–related factors impact FOW. There may be a future trend toward a lower FOW associated with the increasing popularity of daily disposable lenses.

Patient and practitioner compliance with silicone hydrogel and daily disposable lens replacement in the United States

Objective: The objectives of this study were to assess current recommendations for replacement frequency (RF) of silicone hydrogel (SH) and daily disposable (DD) lenses, to determine compliance with these recommendations, and to investigate the reasons given for noncompliance.

Methods: A package containing 20 patient surveys was sent to 309 eye care practitioners (ECPs) in the United States who had agreed to participate in the study. One thousand eight hundred fifty-nine completed surveys were received from 158 ECPs and 1,654 surveys were eligible for analysis. Questions related to patient demographics, lens type, lens wearing patterns, the ECP instructions for RF, and the actual patient reported RF. ECPs were asked to provide lens information and their recommendation for RF after the surveys had been completed and sealed in envelopes. All responses were anonymous.

Results: Sixty-six percent of patients were women and their mean age was 34 ± 12 years. Eighty-eight percent of lenses were worn for daily wear, 12.8 ± 3.2 hours a day, 6.2 ± 1.5 days a week. Lens type distribution was 16% DD, 45% 2 week (2W) SH, and 39% 1 month (1M) SH. ECP recommendations for RF varied according to the lens type; 1% of 1M (95% CI 0.2-1.7), 4% of DD (95% CI 2.1-7.2), and 18% of 2W (95% CI 15.1-20.7) patients were given instructions that did not conform to the manufacturers' recommended RF (MRRF). When considering only those patients who were given the correct instructions for RF, 38% were not compliant with the MRRF; noncompliance rates varied according to the lens type and were 12% for DD (95% CI 8.6-17.2), 28% for 1M (95% CI 24.9-32.1), and 52% for 2W (95% CI 47.8-55.8). The most frequent reasons for over wearing lenses were forgetting which day to replace lenses (51%) and to save money (26%). Fifty-three percent believed that a reminder system would aid compliance; the most popular methods being a cell phone reminder or text message (29%) and a nominated day each week or month (26%). Discussions between the ECPs and the patients were more extensive for patients who were compliant with the MRRF.

Conclusions: ECPs recommended RFs more frequently with DD and 1M SH lenses than with 2W SH lenses, consistent with manufacturers' recommendations. Patients were less compliant with RF than ECPs for all lens types investigated. Patients were most compliant with RF when wearing DD lenses and least compliant when wearing 2W SH lenses. Better communication facilitated greater compliance with RF. More than half of those not replacing lenses, when recommended, reported that this was because they forgot which day to replace their lenses.

Investigation of the performance of the menifocal Z gas-permeable bifocal contact lens during continuous wear

Purpose. The Menifocal Z is an alternating vision, concentric, bifocal gas-permeable (GP) contact lens; center distance is connected to near periphery by a smooth transition zone. The lens is produced using tisilfocon A (Menicon Z material), which is approved for up to 30 days of continuous wear (CW). The aim of this study was to evaluate the clinical performance of the Menifocal Z when worn for up to 30 days of CW for 6 months.

Methods. Thirty-five existing GP lens wearers were enrolled in the study. Subjects were fitted with Menifocal Z lenses and follow-up visits were conducted after 2 weeks of daily wear and 1 day, 1 week, 6 weeks, 3 and 6 months of CW. A range of objective and subjective clinical performance measures were assessed, including distance and near visual acuity, the physiological response to CW, and subjective evaluation of vision and comfort.

Results. Twenty-seven subjects (77%) completed the study and eight (23%) discontinued: five (14%) as a result of lens-related problems (four vision, one comfort) and three (9%) as a result of non-lens related reasons. Average CW time achieved by the subjects was 22 ± 2 days. Mean binocular logarithm of the minimum angle of resolution (logMAR) acuities at 6 months were: high contrast distance 0.03 (20/20-), low contrast distance 0.63 (20/80-), and high contrast near 0.26 (20/25, N4). Adverse responses and lens binding were minimal, and there were no significant increases in corneal staining, corneal vascularization, or superior palpebral conjunctival papillae over time (p > 0.05). Problems with night vision (distance and near) with the lenses were the most common difficulties reported by the subjects.

Conclusions. The Menifocal Z appears to be a promising option for presbyopic vision correction, providing successful correction of distance and near vision in a group of experienced GP lens wearers. The hyper Dk tisilfocon A (Menicon Z) material allowed for safe wear of the lenses on a CW basis.

Patient and practitioner compliance with silicone hydrogel and daily disposable lens replacement in Canada

Purpose: To assess current recommendations by optometrists for replacement frequency (RF) of silicone hydrogels (SH) and daily disposable (DD) contact lenses in Canada, determine rates of non-compliance with recommendations by both the optometrist and patient, and investigate reasons for non-compliance.

Methods: Survey packages were sent to optometrists in Canada who had agreed to participate. Patients completed survey questions regarding demographics and contact lens wearing patterns, including recommended and actual contact lens RF. Optometrists were asked to provide lens information and their recommendation for RF. Fifty-eight optometrists returned 654 surveys, of which 578 were eligible for analysis.

Results: Seventy percent of patients were female with a median age of 32 years. Lens type distribution was 18% DD, 35% two-week SH, and 47% one-month SH. Six percent were worn for extended wear. Daily wear median wearing time was 12 hours/day, a median of five days/week for DD, seven days/week for SH (two-week and one-month). Optometrists’ recommendations were non-compliant with the manufacturers’ recommended RF for 6% of DD, 35% of two week, and 2% of one-month patients. Patients were non-compliant with recommendations from both the manufacturer and optometrist for 12% of DD, 43% of two-week, and 31% of one-month lens wearers. The most common reason for non-compliance was forgetting which day to replace lenses. Fifty-six percent thought a reminder system would help with compliance. A higher proportion of compliant patients followed the RF because of confidence in their optometrist.

Conclusions: Optometrists generally recommended RFs consistent with manufacturers’ recommendations for DD and one-month SH lenses but often recommended longer intervals for two-week SH lenses. Patients were most compliant when wearing DD lenses and least compliant when wearing two-week SH lenses. Communication between the patient and optometrists concerning the risks of non-compliance, or initiating a reminder system might improve compliance.

Determinants of the frequency of contact lens wear

To characterize and discover the determinants of the frequency of wear (FOW) of contact lenses. Survey forms were sent to contact lens fitters in up to 40 countries between January and March every year for 5 consecutive years (2007–2011). Practitioners were asked to record data relating to the first 10 contact lens fits or refits performed after receiving the survey form. Only data for daily wear lens fits were analyzed. Data were collected in relation to 74,510 and 9,014 soft and rigid lens fits, respectively. Overall, FOW was 5.9±1.7 days per week (DPW). When considering the proportion of lenses worn between one to seven DPW, the distribution for rigid lenses is skewed toward full-time wear (7 DPW), whereas the distribution for soft daily disposable lenses is perhaps bimodal, with large and small peaks at seven and two DPW, respectively. There is a significant variation in FOW among nations (P<0.0001), ranging from 6.8±1.0 DPW in Greece to 5.1±2.5 DPW in Kuwait. For soft lenses, FOW increases with decreasing age. Females (6.0±1.6 DPW) wear lenses more frequently than males (5.8±1.7 DPW) (P=0.0002). FOW is greater among those wearing presbyopic corrections (6.1±1.4 DPW) compared with spherical (5.9±1.7 DPW) and toric (5.9±1.6 DPW) designs (P<0.0001). FOW with hydrogel peroxide systems (6.4±1.1 DPW) was greater than that with multipurpose systems (6.2±1.3 DPW) (P<0.0001).

Conjunctival epithelial flaps with 18 months of silicone hydrogel contact lens wear

Purpose. To report differences in the incidence of conjunctival epithelial flaps (CEFs) found in a group of neophyte contact wearers using two different silicone hydrogel contact lenses on a daily- and continuous-wear basis during an 18-month period. Methods. Sixty-one subjects were initially examined, and 53 were eligible to participate in the study. Eligible subjects were randomly assigned to wear one of two silicone hydrogel materials, lotrafilcon A or balafilcon A, on a daily- or continuous-wear basis. After an initial screening, subjects were monitored weekly for the first month and then after 3, 6, 12, and IS months. The incidence of CEFs in each of the four contact lens groups was recorded. Results. Five of the 53 subjects enrolled in the study showed bilateral CEFs. A higher incidence of CEFs was found in subjects wearing lotrafilcon A lenses (n = 4) compared to balafilcon A lenses (it = 1) (chi(2) = 4.37, P=0.04). Differences in the incidence of CEFs between subjects wearing lenses on a daily-wear basis (n = 1) versus a continuous-wear basis (it = 4) showed a weak statistical significance (chi(2) = 3.03, P=0.08). Conclusions. Lotrafilcon A lenses were associated with a higher incidence of CEFs than balafilcon A lenses were, and this difference may be attributed to differences in the edge design, material, or modulus of rigidity between the two lens types. Subjects wearing lenses on a daily-wear basis showed fewer adverse events than did subjects wearing lenses on a continuous-wear basis. The longer wearing times of subjects wearing lenses on a continuous-wear basis are likely to exacerbate the incidence of CEFs.