Ocular discomfort responses after short periods of contact lens wear.

PURPOSE: To investigate if contact lens-related discomfort is a function of the time of day at which lenses are worn. METHODS: This was a randomized, crossover, open-label clinical trial where subjective responses, with and without contact lenses, were assessed every 2 hours during five stages (A to E). Each stage began at the time when subjects would normally have inserted their contact lenses (T0). During stage A, no lenses were worn, whereas in stage B, lenses were worn continuously for 12 hours. In stages C to E, lenses were worn for only 4 hours. Contact lenses were inserted at T0 for stage C, but for stages D and E, lenses were not inserted until T0 + 4 and T0 + 8 hours, respectively. Mixed linear models were used for statistical analysis. RESULTS: In the absence of contact lenses, ocular comfort and dryness remained reasonably constant throughout the observation period. Ocular comfort and dryness decreased during 12 hours of continuous lens wear and became significantly worse from the 8-hour time onward compared with insertion (p < 0.023). There were no significant differences in terms of ocular comfort and dryness between any of the 4-hour lens wear stages (p < 0.82). During each 4-hour stage, both comfort and dryness behaved in a similar fashion (p > 0.05) to the first 4 hours of continuous contact lens wear. Comparing the scores of each of these stages with the no-lens response at the corresponding time showed no significant differences for comfort (p > 0.23) or dryness (p > 0.37). CONCLUSIONS: Short periods of wear can be experienced at any time of day without significant change in ocular discomfort and dryness. This suggests that subjective responses at the end of the day are determined by the length of time lenses are in contact with the eye, rather than the time of day at which lenses are worn.

Effect of Daily Contact Lens Cleaning on Ocular Adverse Events during Extended Wear.

PURPOSE: The purpose of the study was to assess what effect daily cleaning of contact lenses with a multipurpose disinfection solution (MPDS), during 30 nights extended wear, would have on contact lens-related adverse events. METHODS: This was a prospective, open-label, randomized, controlled, parallel-group, 3-month clinical study in which 193 participants were dispensed with lotrafilcon A silicone hydrogel lenses for a 30-day extended-wear schedule and with lenses replaced monthly. Participants were randomized to a control or test group. Test subjects were required to remove lenses daily after waking, clean them with the MPDS, and reinsert the lenses. Control subjects wore lenses without removal for 30 days extended wear. Handling-related lens contamination was assessed at the baseline visit. RESULTS: There was no significant difference between the test and control groups for the incidence of significant corneal infiltrative events (1.3 vs. 4.9%, p = 0.368), total corneal infiltrative events (2.6 vs. 4.9%, p = 0.682), or mechanical events (1.3 vs. 2.5%, p = 1.00). The test group had greater corneal staining (p < 0.047) and fewer mucin balls (p = 0.033). Handling-related lens contamination (unworn lenses) resulted in isolation of Gram-positive bacteria from 92.5% of test lenses compared with 87.5% of control lenses (p = 0.712). Gram-negative bacteria were isolated from 5% of test subjects compared with 2.5% of control subjects (p = 1.00). Fungus was isolated from 2.5% of subjects in both the test and control groups (p = 1.00). CONCLUSIONS: The intervention of daily morning cleaning of the lens surface with an MPDS during extended wear did not significantly influence the incidence of adverse events.

Release of betaine and dexpanthenol from vitamin E modified silicone-hydrogel contact lenses.

PURPOSE: To develop a contact lens system that will control the release of an osmoprotectant and a moisturizing agent with the aim to reduce symptoms of ocular dryness. MATERIALS AND METHODS: Profiles of the release of osmoprotectant betaine and moisturizing agent dexpanthenol from senofilcon A and narafilcon B contact lenses were determined in vitro under sink conditions. Both types of lenses were also infused with vitamin E to increase the duration of drug release due to the formation of the vitamin E diffusion barriers in the lenses. The release profiles from vitamin E-infused lenses were compared with those from the control lenses. RESULTS: Both dexpanthenol and betaine are released from commercial silicone hydrogel lenses for only about 10 min. Vitamin E loadings into contact lenses at about 20-23% can increase the release times to about 10 h, which is about 60 times larger compared to the control unmodified lenses. CONCLUSIONS: Vitamin E-loaded silicone hydrogel contact lenses released betaine and dexpanthenol in a controlled fashion.

Influence of contact lens power profile on peripheral refractive error.

PURPOSE: To measure the power profile across the optic zone (OZ) of four commercially available soft contact lenses and establish the impact on the peripheral refractive error of the eye. METHODS: The power profiles of a spherical conventional hydrogel contact lens (etafilcon A, J&J Vistakon, Jacksonville, FL USA) and three spherical silicone hydrogel contact lenses (lotrafilcon A and B, CIBA Vision, Duluth, GA USA; enfilcon A, CooperVision, Pleasanton, CA USA) with a labeled power of -3.00 and -6.00 diopters were measured using a Shack-Hartmann wavefront sensor power mapping device. Central and peripheral refraction across the horizontal meridian (nasal and temporal visual field at 20, 30, and 40 degrees) was measured with an open-field autorefractor (Shin Nippon NVision K5001, Osaka Japan) with and without contact lenses in 26 myopic subjects. The relative peripheral refractive error on the eye was estimated and compared with and without contact lenses and between contact lenses. RESULTS: Differences in the distribution of the power profile across the OZ were apparent between contact lens types and powers. No significant differences (p > 0.05) were found between contact lens types for their effect on on-axis refraction. Significant differences (p < 0.05) were found at all peripheral retinal eccentricities between contact lens types. CONCLUSIONS: For a given central power, the four contact lenses exhibited variations in optical power across the OZ of the lens. The distribution of optical power across the OZ has an influence on the peripheral refractive error of the eye.

Effect of antibiotic drops on adverse events during extended lens wear.

PURPOSE: Overnight lens wear is associated with increased lens contamination and risk of developing a corneal infiltrate or infectious event. Antibacterial lenses have been proposed as a potential strategy for reducing lens contamination. A proof-of-principle study was conducted to investigate what effect control of potential pathogens, through the use of antibiotic eye drops, would have on the incidence of corneal infiltrative events (CIEs) and on the ocular microbiota and lens contamination. METHODS: This is a prospective, open-label, controlled, parallel-group, 1-month clinical study in which 241 subjects were dispensed with lotrafilcon A silicone hydrogel lenses for 30 days of continuous wear. Subjects were randomized into either test (moxifloxacin 0.5%) or control (rewetting solution) group. One drop was instilled into each eye on waking and before sleeping, while lenses were on-eye. Follow-ups were conducted after one night and 1 month. Lid margin swabs were taken at baseline and at 1 month and worn lenses were aseptically collected at 1 month. RESULTS: The incidence of CIEs was not significantly different between the test (2.6%) and control (3.9%) groups (p = 0.72). Microorganism levels from the test group swabs were significantly lower than those from the control group (p = 0.001). Gram-positive bacteria were less frequently recovered from lower lid swabs from the test group (39.6% vs. 66.0% [p < 0.001], test vs. control, respectively) or from contact lens samples (1.9% vs. 10.5% [p = 0.015], test vs. control, respectively), but there was no difference in gram-negative bacteria (GNB). Corneal infiltrative events were associated with higher levels of lens contamination (p = 0.014) and contamination of lenses with GNB (CIE: 7.3% vs. 0.6% [p = 0.029], GNB contamination vs. no GNB contamination, respectively). DISCUSSION: Twice-daily antibiotic instillation during continuous wear of lenses did not significantly influence the rate of inflammatory events. Corneal infiltrative events were associated with higher levels of lens contamination in general and with contamination by GNB specifically.

Lens parameter changes under in vitro and ex vivo conditions and their effect on the conjunctiva.

PURPOSE: To quantify changes in contact lens parameters induced by lens wear and determine whether these changes are associated with contact lens-induced conjunctival staining (CLICS). METHODS: In vitro: Lens diameter, sag, edge shape, base curve of six contact lens brands (balafilcon, comfilcon, etafilcon, lotrafilcon B, omafilcon and senofilcon) measured at 21°C and 35°C (eye temperature). Ex vivo: Diameter of lenses collected from a prospective, randomised, contra-lateral, cross-over clinical trial from 36 subjects wearing all lens types for 1 week daily wear, measured in 35°C PBS after removal. Ocular surface was examined for lens-induced conjunctival staining by masked examiner. RESULTS: In vitro: Changes in diameter and base curve outside ISO tolerance were found with etafilcon A and omafilcon A. Ex vivo: Comfilcon A and etafilcon A had greatest shrinkage in diameter (0.18mm) and base curve (0.11mm steeper) with temperature increase from 21°C to 35°C. Senofilcon A, lotrafilcon B and balafilcon A maintained most stable parameters between 21°C and 35°C. Changes in diameter and base curve from lens wear were not correlated with CLICS (p>0.49). Multivariate analysis showed significantly greater levels of lens induced staining were associated with lens modulus (p<0.001) and knife (p<0.001) and chisel (p<0.001) edge shapes. CONCLUSIONS: Parameter changes induced by lens wear were associated with increasing temperature, but these changes in lens diameter and base curve did not induce CLICS. Modulus and edge shape were associated with increased CLICS. The susceptibility of etafilcon A and omafilcon A lenses to parameter changes might be related to their high water content.

The effect of daily lens replacement during overnight wear on ocular adverse events.

PURPOSE: Compared with daily disposable wear schedule, continuous wear (CW) or extended wear of contact lenses has been associated with an increased risk of developing an ocular infection. Proof-of-principle studies were conducted to investigate the impact of daily replacement of lenses on the rate of contact lens-related ocular adverse events (AEs) during 30-night CW. METHODS: A total of 215 subjects were dispensed with silicone hydrogel lenses on a 30-night CW schedule but replaced lenses daily either each night before sleeping (n = 178 eyes) or each morning after waking (n = 252 eyes). Scheduled clinic visits were conducted at 1 week and 1 month. Neophytes were required to complete 1 week of daily wear before commencing CW. A historical control (n = 191 eyes) using the same site, subject demographics, and visit schedule but monthly lens replacement was used for AE rates. RESULTS: Logistic regression analysis showed a significant reduction in mechanical AEs (0.8 vs 5.2%, p = 0.01) and overall AEs (inflammatory and mechanical events) (4.0 vs 8.9%, p = 0.04) when lenses were replaced each morning compared with being replaced monthly. Estimation of handling-related lens contamination of unworn lenses in a subgroup of subjects showed isolation of Staphylococcus aureus from the lenses of 35% of subjects, and 65% of subjects had more than 1000 colony-forming units per lens of gram-positive bacterial contamination. CONCLUSIONS: Morning lens replacement during CW reduced mechanical and overall ocular AEs. Replacing lenses at night had no beneficial effects perhaps because the benefit of a fresh lens at night might be partially negated by contamination of the contact lens caused by lens handling before overnight eye closure. Contact lens wearers on an extended wear or CW schedule should be advised to minimize lens handling before sleep to reduce the risk of complications.

In vivo oxygen uptake into the human cornea.

PURPOSE: We provide a new procedure to quantify in situ corneal oxygen uptake using the micropolarographic Clark electrode. METHODS: Traditionally, upon placing a membrane-covered Clark microelectrode onto a human cornea, the resulting polarographic signal is interpreted as the oxygen partial pressure at the anterior corneal surface. However, the Clark electrode operates at a limiting current. Hence, oxygen flux is directly detected rather than partial pressure. We corrected this misunderstanding and devised a new analysis to quantify oxygen uptake into the cornea. The proposed analysis is applied to new polarographic data for 10 human subjects during open-eye oxygen uptake. RESULTS: Average open-eye corneal oxygen uptake over 10 subjects is approximately 11 µL/(cm(2) h), approximately five times larger than the average reported by researchers who invoke the original mathematical analysis. Application of the classical interpretation scheme to our experimental data also garners uptake values that are approximately a factor of three to five times smaller than those obtained with our new procedure. CONCLUSIONS: The classical procedure originally developed by Fatt and colleagues misinterprets the behavior of the Clark microelectrode. We corrected the analysis of the in situ polarographic technique to provide a simple yet rigorous procedure for analyzing both previous data in the literature and those newly obtained. Our proposed interpretation scheme thus provides a reliable tool for in vivo assessment of corneal oxygen uptake.

Decrease in rate of myopia progression with a contact lens designed to reduce relative peripheral hyperopia: one-year results.

PURPOSE: To determine whether a novel optical treatment using contact lenses to reduce relative peripheral hyperopia can slow the rate of progress of myopia. METHODS: Chinese children, aged 7 to 14 years, with baseline myopia from sphere -0.75 to -3.50 D and cylinder ≤1.00 D, were fitted with novel contact lenses (n = 45) and followed up for 12 months, and their progress was compared with that of a group (n = 40) matched for age, sex, refractive error, axial length, and parental myopia wearing normal, single-vision, spherocylindrical spectacles. RESULTS: On adjusting for parental myopia, sex, age, baseline spherical equivalent (SphE) values, and compliance, the estimated progression in SphE at 12 months was 34% less, at -0.57 D, with the novel contact lenses (95% confidence interval [CI], -0.45 -0.69 D) than at -0.86 D, with spectacle lenses (95% CI, -0.74 to -0.99 D). For an average baseline age of 11.2 years, baseline SphE of -2.10 D, a baseline axial length of 24.6 mm, and 320 days of compliant lens wear, the estimated increase in axial length (AL) was 33% less at 0.27 mm (95% CI, 0.22-0.32 mm) than at 0.40 mm (95% CI, 0.35-0.45 mm) for the contact lens and spectacle lens groups, respectively. CONCLUSIONS: The 12-month data support the hypothesis that reducing peripheral hyperopia can alter central refractive development and reduce the rate of progress of myopia. (chictr.org number, chiCTR-TRC-00000029 or chiCTR-TRC-00000032.).

Contact lens case contamination during daily wear of silicone hydrogels.

PURPOSE: Contamination of contact lens cases has been associated with the production of adverse responses in the eye during contact lens wear. This study aimed to evaluate the contamination rate and types of microbes contaminating cases during use of contact lens disinfecting solutions and silicone hydrogel lenses. METHODS: Two hundred thirty-two participants were allocated to one or more groups. The participants wore one or more of three silicone hydrogel lenses and used one or more of four contact lens disinfecting solutions. Cases were collected after use for 1 month and sent for routine microbial testing. The rate of contamination of cases and the types of microbes contaminating cases were evaluated. RESULTS: Between 76 and 92% of all cases were contaminated. Use of different contact lenses did not affect contamination rate or the types of microbes isolated from cases. Use of AQuify (PHMB as disinfectant) was associated with the highest contamination rate (92%; p = 0.015) of cases for any microbe. Level and type of contamination with use of ClearCare (H2O2) was similar to use of PHMB (polyhexamethylene biguanide)- or Polyquat/Aldox-containing solutions. There was no difference in contamination rate of cases by fungi or Gram-positive bacteria, but for Gram-negative bacteria, use of Opti-Free Express (Polyquat and Aldox as disinfectants) resulted in a lower contamination rate (7% vs. 29 to 45%; p < 0.001). The average number of microbes contaminating a case was significantly less for Opti-Free Express (223 +/- 1357 cfu/case) compared with Opti-Free RepleniSH (Polyquat and Aldox as disinfectants; 63,244 +/- 140,630 cfu/case; p < 0.001), driven mostly by differences in numbers of Gram-negative bacteria, particularly contamination by Delftia acidovorans in cases exposed to Opti-Free RepleniSH. CONCLUSIONS: Different disinfecting solutions used during storage in cases result in different levels of contamination and contamination by different types of microbes. These differences are not simply because of the types of disinfectants used, suggesting that other excipients in, or formulation of, the solution affect contact lens storage case contamination.

Influence of accommodation on off-axis refractive errors in myopic eyes.

INTRODUCTION: This study aims to understand off-axis refraction during accommodation and to identify whether the relative hyperopia generally observed in myopic eyes changes with accommodation. METHOD: Twenty bilateral myopes (18 to 33 years) between -0.50 D and -4.25 D (spherical equivalent) and astigmatism less than 1.25 D participated in this study. A soft contact lens was used to correct refractive error for all measurements. Non-cycloplegic autorefraction was measured at the fovea and 20 degrees, 30 degrees, and 40 degrees eccentricities in the nasal and temporal retina at distances of 2 m, 40 cm, and 30 cm. RESULTS: Peripheral refractive error, relative to central refraction, became less hyperopic with increasing eccentricity and with increasing accommodation. Lag of accommodation increased with accommodation (p < 0.001) shifting the image-shell backward relative to the retina. In the farther periphery, there was either no change in refractive error or increased myopic shifts with accommodation. Astigmatism increased with eccentricity and significantly increased in the farther eccentricities with accommodation (p < 0.001). CONCLUSION: Myopes display hyperopic shifts in the center and near peripheral field during near-viewing, while the farther periphery either remains unshifted or demonstrates a myopic shift. These results are due to the combined effect of lag of accommodation and an increased curvature of field during accommodation.

Lid and conjunctival micro biota during contact lens wear in children.

PURPOSE: To determine the types of microorganisms and their frequency of isolation on the external ocular surface in children wearing soft contact lenses on a daily wear schedule. METHODS: Children aged 8 to 14 years were fitted with commercially available, soft contact lenses which were worn on a daily wear basis. The upper bulbar conjunctiva and the lower lid margins of each eye were swabbed at baseline and then at 6-monthly intervals for 2 years during lens wear. Swabs were processed, cultured and microorganisms identified using standard microbiological techniques. RESULTS: At baseline, 36% of the upper bulbar conjunctivae and 53% of the lower lid margins were contaminated with predominantly gram-positive bacteria. Recovery of samples with positive growth from the upper bulbar conjunctivae decreased during lens wear and ranged from 27 to 14%. The difference was statistically significant at the 12-month visit(14%, p = 0.011). The lower lid margins generally showed similar levels of contamination as at baseline except for less contamination at the 12-month visit (33%) (p = 0.05). Staphylococcus epidermidis and Propionibacterium sp. were the predominant microorganisms isolated from both the sites with and without lens wear. Gram-negative bacteria were infrequent and when isolated, the numbers of colonies were few. Fungus was isolated in a small percent (ranging from 0 to 4.8%) of eyes at various time points. CONCLUSIONS: The external ocular surface of children is contaminated with gram-positive bacteria that are resident microbiota. During lens wear, there was a trend for lesser recovery of organisms from the upper bulbar conjunctival samples,but there was no change in the type of microorganisms isolated. At all times, lower lid margins showed consistently greater colonization and is a source of potential contamination of the conjunctival surface.

Contact lenses: optimal vision--sub-optimal carrier?

The development of silicone hydrogel contact lenses with high oxygen permeabilities is a major step forward in vision correction. This advance in contact lenses material technology provides breakthrough levels of oxygen to the cornea. However, there are still important issues yet to be addressed by researchers, practitioners, and industry. Factors such as adequate correction for all refractive errors, microbial keratitis, comfort, and suitable lens care and lens biocompatibility are discussed from the authors' perspective.