CLEAR - Effect of contact lens materials and designs on the anatomy and physiology of the eye.

This paper outlines changes to the ocular surface caused by contact lenses and their degree of clinical significance. Substantial research and development to improve oxygen permeability of rigid and soft contact lenses has meant that in many countries the issues caused by hypoxia to the ocular surface have largely been negated. The ability of contact lenses to change the axial growth characteristics of the globe is being utilised to help reduce the myopia pandemic and several studies and meta-analyses have shown that wearing orthokeratology lenses or soft multifocal contact lenses can reduce axial length growth (and hence myopia). However, effects on blinking, ptosis, the function of Meibomian glands, fluorescein and lissamine green staining of the conjunctiva and cornea, production of lid-parallel conjunctival folds and lid wiper epitheliopathy have received less research attention. Contact lens wear produces a subclinical inflammatory response manifested by increases in the number of dendritiform cells in the conjunctiva, cornea and limbus. Papillary conjunctivitis is also a complication of all types of contact lenses. Changes to wear schedule (daily disposable from overnight wear) or lens materials (hydrogel from SiHy) can reduce papillary conjunctivitis, but the effect of such changes on dendritic cell migration needs further study. These changes may be associated with decreased comfort but confirmatory studies are needed. Contact lenses can affect the sensitivity of the ocular surface to mechanical stimulation, but whether these changes affect comfort requires further investigation. In conclusion, there have been changes to lens materials, design and wear schedules over the past 20+ years that have improved their safety and seen the development of lenses that can reduce the myopia development. However, several changes to the ocular surface still occur and warrant further research effort in order to optimise the lens wearing experience.

The short-term physiological impact of switching reusable silicone hydrogel wearers into a hydrogel daily disposable multifocal.

Purpose: To evaluate ocular physiological responses to etafilcon A multifocal (etMF) daily disposable (DD) lenses after 4 weeks of wear, when switching from habitual silicone hydrogel (SiHy) daily wear. Method: A single-arm, open-label, bilateral dispensing study was conducted in 39 habitual spherical SiHy wearers (14 hyperopes; 25 myopes). Clinical visits occurred with habitual SiHy (control) at baseline and after 4 weeks of etMF DD open-eye lens wear at exit. Objective limbal/bulbar hyperemia using the Oculus K5M (0-4) and subjective grading of lid wiper epitheliopathy (LWE) (0-4) were tested for non-inferiority (NI), using a margin of 1 grade. Corneal thickness along a 10 mm cord was measured using the Visante OCT and tested for NI using a 30 µm margin. Corneal staining area was graded (0-100%). Results: The least-square mean differences (LSMD) and 95% confidence interval (95% CI) between etMF DD and habitual SiHy in central and peripheral corneal thickness (µm) were 3.64 (-2.0, 9.29) and 3.0 (-7.72, 13.72) in hyperopic, and 3.56 (-0.66, 7.78) and 6.40 (-1.62, 14.42) in myopic subjects. The LSMD (95% CI) for bulbar and limbal hyperemia were -0.08 (-0.19, 0.02) and -0.01 (-0.12, 0.09) in hyperopes, and 0.04 (-0.03, 0.12) and 0.04 (-0.04, 0.11) in myopes. The LSMD (95% CI) for LWE were 0.11 (-0.39, 0.60) and 0.30 (-0.07, 0.67) for hyperopes and myopes, respectively. Conclusions: No clinically significant differences in a variety of physiological responses were found when habitual reusable SiHy daily wear subjects were refitted into hydrogel etMF, when the subjects were followed for 4 weeks.

Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose.

PURPOSE: To compare the efficacy and safety of a preservative-free, multi-ingredient formulation of carboxymethylcellulose 0.5%, hyaluronic acid 0.1%, and organic osmolytes (CMC-HA), to preservative-free carboxymethylcellulose 0.5% (CMC) in the management of postoperative signs and symptoms of dry eye following laser-assisted in situ keratomileusis (LASIK). METHODS: This was a double-masked, randomized, parallel-group study conducted in 14 clinical centers in Canada and Australia. Subjects with no more than mild dry eye instilled CMC-HA or CMC for 90 days post-LASIK. Ocular Surface Disease Index© (OSDI; primary efficacy measure), corneal staining, tear break-up time (TBUT), Schirmer's test, acceptability/tolerability surveys, and visual acuity were assessed at screening and days 2, 10, 30, 60, and 90 post-surgery. Safety analyses included all enrolled. RESULTS: A total of 148 subjects (CMC-HA, n=75; CMC, n=73) were enrolled and assigned to receive treatment, and 126 subjects completed the study without any protocol violations. Post-LASIK, dry eye signs/symptoms peaked at 10 days. OSDI scores for both groups returned to normal with no differences between treatment groups at day 90 (P=0.775). Corneal staining, Schirmer's test, TBUT, and survey results were comparable. Higher mean improvements in uncorrected visual acuity were observed in the CMC-HA group at all study visits, reaching statistical significance at day 30 (P=0.013). Both treatments were well tolerated. CONCLUSION: CMC-HA-containing artificial tears relieved post-LASIK ocular dryness as well as CMC alone, and demonstrated incremental benefit in uncorrected vision, with a favorable safety profile. Results support use of CMC-HA eye drops to reduce signs and symptoms of ocular dryness post-LASIK.

Mixed Model Analysis of Between-Subject Variability in Overnight Corneal Swelling and Deswelling With Silicone Hydrogel Lenses.

Purpose: To model between subject variability of corneal swelling (CS) and deswelling after overnight wear of silicone hydrogel (SiHy) contact lenses. Methods: A total of 29 neophyte subjects wore 12 SiHy lenses with central transmissibility range of 31 to 211 Dk/t units on separate nights, in random order, and on one eye only. The contralateral eye served as the control. Central corneal thickness was measured using digital optical pachymetry before lens insertion, immediately after lens removal on waking, then 20, 40 minutes, 1, 2, and 3 hours later. Mixed modelling was conducted for simultaneous analysis of group and between-subject effects of CS and deswelling. Results: The best model for overnight CS versus Dk/t was linear with a random intercept showing constant between-subject differences in CS for different Dk/t values. The best fit for corneal deswelling versus time was a curvilinear random intercept and random slope model. About 90% of the total between-subject deswelling variance in either lens or control eyes was due to the intercept variability with much less (∼10%) being due to the variability of the individual deswelling rate (slope). Subject age, sex, and ametropia were not predictors of individual corneal swelling in the swelling versus Dk/t analysis. Age, however, was a significant (inverse) predictor of the rate of corneal deswelling, only in lens-wearing eyes. Conclusions: A large proportion of variability in corneal swelling is because of subject-specific differences in corneal response to hypoxia. This shows that "low swellers" and "high swellers" actually do exist.

Eyelid Margin and Meibomian Gland Characteristics and Symptoms in Lens Wearers.

PURPOSE: To describe the lid margin characteristics of contact lens wearers and relate them to comfort during lens wear. METHODS: Three study sites enrolled habitual contact lens wearers. Subjects completed the Comfort domain of the Contact Lens User Experience (CLUE) questionnaire, and each eye was graded for the presence of mucocutaneous junction (MCJ) displacement, lid margin irregularity, and lid margin vascularity. Examiners counted the number of meibomian gland (MG) orifices in the central centimeter of the lower eyelid and the number of those that showed pouting/plugging and vascular invasion. MG expressibility was graded according to the Shimazaki schema. Subjects were grouped based on presence/absence of each characteristic, total number of orifices (≥5 vs. <5), and expressibility (grade 0 vs. >0). Descriptive statistics are reported. A linear model was used to assess the fixed effect of each characteristic on combined CLUE score and each CLUE statement, if the effect on combined CLUE score showed p < 0.10. RESULTS: The study included 203 subjects (67.5% female) with mean age (±SD) of 30.3 ± 9.6 years. The most commonly observed characteristics were orifice pouting/plugging, compromised MG expressibility, and lid margin vascularity (35.0, 30.3, and 20.4%, respectively). MCJ displacement and MG expressibility had an effect on the combined CLUE score such that individual CLUE statements were analyzed (p = 0.01 and p = 0.06, respectively). MCJ displacement had an effect on comfort upon insertion (p = 0.01), comfort after 5 minutes (p = 0.03), end-of-day comfort (p = 0.01), and ability to maintain ocular moisture (p = 0.030). MG expressibility had a significant effect on general comfort (p = 0.01), comfort throughout the day (p = 0.02), and the ability to maintain ocular moisture (p = 0.02). CONCLUSIONS: MCJ displacement and MG expressibility have an effect on contact lens comfort.

Corneal Swelling with Cosmetic etafilcon A Lenses versus No Lens Wear.

PURPOSE: To determine if the use of pigments or adding polyvinyl pyrrolidone during the fabrication of 1-DAY ACUVUE DEFINE (AD) brand contact lenses impacts open-eye corneal swelling compared with no lens wear (NLW). METHODS: A partial double-masked, randomized, bilateral crossover study was conducted in 24 Asian subjects using AD, 1-DAY ACUVUE DEFINE with Lacreon (ADL), NLW, and a control lens with no tint (1-DAY ACUVUE MOIST [AM]). Central corneal thickness was measured before insertion and immediately after removal after 8 ± 1 h of open-eye wear using an optical pachymeter in one eye. Corneal thickness along a 10-mm cord was measured in the contralateral eye using the Visante optical coherence tomographer (OCT). Corneal swelling was tested for noninferiority using a 5% margin. The endothelial bleb response was measured at baseline and 20 min after lens insertion using specular microscopy. Subjective grading of corneal staining and limbal/bulbar hyperemia were also monitored. RESULTS: After 8 ± 1 h of open-eye wear, central corneal swelling across the study lenses with either optical pachymeter or OCT methods was negligible. Peripheral corneal swelling least-square mean differences with OCT were -0.03% (95% confidence interval [95% CI], -0.65 to 0.58%) and -0.26% (95% CI, -0.87 to 0.36%) between AD and ADL and the control lens (AM), respectively, and 1.67% (95% CI, 1.06 to 2.29%) and 1.45% (95% CI, 0.84 to 2.06%) between AD and ADL and NLW, respectively. No endothelial blebs were observed. No clinically significant differences were distinguished between the lenses and NLW for corneal staining and limbal/bulbar hyperemia. CONCLUSIONS: After 8 ± 1 h of open-eye wear, central and peripheral corneal swelling along the horizontal meridian with AD, ADL, AM, and NLW were equivalent. These results confirm that the addition of polyvinyl pyrrolidone or pigments to etafilcon A to obtain a limbal ring design have no impact on corneal swelling or limbal/bulbar hyperemia during normal open-eye wear.

Overnight corneal swelling with high and low powered silicone hydrogel lenses / Edema corneal durante la noche, con el uso de lentes de hidrogel de silicona de alta y baja potencia

Purpose: To compare central corneal swelling after eight hours of sleep in eyes wearing four different silicone hydrogel lenses with three different powers. Methods: Twenty-nine neophyte subjects wore lotrafilcon A (Dk, 140), balafilcon A (Dk, 91), galyfilcon A (Dk, 60) and senofilcon A (Dk, 103) lenses in powers −3.00, −10.00 and +6.00 D on separate nights, in random order, and on one eye only. The contra-lateral eye (no lens) served as the control. Central corneal thickness was measured using a digital optical pachometer before lens insertion and immediately after lens removal on waking. Results: For the +6.00 D and −10.00 D, lotrafilcon A induced the least swelling and galyfilcon A the most. The +6.00 D power, averaged across lens materials, induced significantly greater central swelling than the −10.00 and −3.00 D (Re-ANOVA, p < 0.001), (7.7 ± 2.9% vs. 6.8 ± 2.8% and 6.5 ± 2.5% respectively) but there was no difference between −10.00 and −3.00 D. Averaged for power, lotrafilcon A induced the least (6.2 ± 2.8%) and galyfilcon A the most (7.6 ± 3.0%) swelling at the center (Re-ANOVA, p < 0.001). Central corneal swelling with +6.00 D was significantly greater than −10.00 D lens power despite similar levels of average lens transmissibility of these two lens powers. Conclusions: The differences in corneal swelling of the lens wearing eyes are consistent with the differences in oxygen transmission of the silicone hydrogel lenses. In silicone hydrogel lenses central corneal swelling is mainly driven by central lens oxygen transmissibility (AU)

Objetivo: Comparar el edema central de la córnea tras ocho horas de sueño, en ojos con cuatro lentes diferentes de hidrogel de silicona de tres potencias diferentes. Métodos: Veintinueve pacientes no usuarios de lentes de contacto llevaron lentes de lotrafilcon A (Dk, 140), balafilcon A (Dk, 91), galyfilcon A (Dk, 60) y senofilcon A (Dk, 103) con potencias de −3,00, −10,00 y +6.00 D durante noches diferentes, en orden aleatorio, y en un solo ojo. El ojo contra-lateral (sin lente) se utilizó como control. El espesor central de la córnea se midió utilizando un paquímetro óptico digital antes de la inserción e inmediatamente tras la retirada de la lente al despertar. Resultados: Para +6,00 D y −10,00 D, lotrafilcon A produjo el menor edema, comparado con galyfilcon A. La potencia +6,00 D, promediada en los materiales de las lentes, produjo un edema central considerablemente mayor que las potencias −10,00 y −3,00 D (Re-ANOVA, p < 0,001), (7,7 ± 2,9% frente a 6,8 ± 2,8% y 6,5 ± 2,5% respectivamente), pero no existió diferencia entre −10,00 y −3,00 D. Promediando las potencias para cada lente, lotrafilcon A produjo el menor edema en el centro (6,2 ± 2,8%) y galyfilcon A la mayor (7,6 ± 3,0%) (Re-ANOVA, p < 0,001). El edema corneal central con +6,00 D fue considerablemente superior que la de la potencia de lente −10,00 D, a pesar de los niveles similares de transmisibilidad media de la lente de estas dos potencias. Conclusiones: Las diferencias en cuanto a edema de la córnea de los ojos portadores de lentes son consistentes con las diferencias en cuanto a transmisión del oxígeno de las lentes de hidrogel de silicona. En las lentes de hidrogel de silicona, el edema corneal central es principalmente debido a la transmisibilidad del oxígeno central de la lente (AU)

Overnight corneal swelling with high and low powered silicone hydrogel lenses.

PURPOSE: To compare central corneal swelling after eight hours of sleep in eyes wearing four different silicone hydrogel lenses with three different powers. METHODS: Twenty-nine neophyte subjects wore lotrafilcon A (Dk, 140), balafilcon A (Dk, 91), galyfilcon A (Dk, 60) and senofilcon A (Dk, 103) lenses in powers -3.00, -10.00 and +6.00 D on separate nights, in random order, and on one eye only. The contra-lateral eye (no lens) served as the control. Central corneal thickness was measured using a digital optical pachometer before lens insertion and immediately after lens removal on waking. RESULTS: For the +6.00 D and -10.00 D, lotrafilcon A induced the least swelling and galyfilcon A the most. The +6.00 D power, averaged across lens materials, induced significantly greater central swelling than the -10.00 and -3.00 D (Re-ANOVA, p<0.001), (7.7±2.9% vs. 6.8±2.8% and 6.5±2.5% respectively) but there was no difference between -10.00 and -3.00 D. Averaged for power, lotrafilcon A induced the least (6.2±2.8%) and galyfilcon A the most (7.6±3.0%) swelling at the center (Re-ANOVA, p<0.001). Central corneal swelling with +6.00 D was significantly greater than -10.00 D lens power despite similar levels of average lens transmissibility of these two lens powers. CONCLUSIONS: The differences in corneal swelling of the lens wearing eyes are consistent with the differences in oxygen transmission of the silicone hydrogel lenses. In silicone hydrogel lenses central corneal swelling is mainly driven by central lens oxygen transmissibility.

Distribution of overnight corneal swelling across subjects with 4 different silicone hydrogel lenses.

PURPOSE: To determine distribution of central corneal swelling (CCS) across subjects after 8 hr of sleep in eyes wearing silicone hydrogel lenses with various oxygen transmissibility (Dk/t) values and in eyes without lenses. METHODS: Twenty-nine neophytes wore lotrafilcon A (Dk, 140), balafilcon A (Dk, 91), galyfilcon A (Dk, 60), and senofilcon A (Dk, 103) lenses in powers -3.00, -10.00, and +6.00 diopters on separate nights, in random order, and on 1 eye only. The contralateral eye (no lens) served as the control. Central corneal thickness was measured using a digital optical pachometer before lens insertion and immediately after lens removal on waking. RESULTS: The average difference between the mean (7%) and the median (6.8%) CCS of all lenses was only 0.2%, suggesting a normal distribution. There was no correlation between the mean and the range of the CCS (r=0.058, P=0.766). Normal CCS distributions were also found with each lens-wearing eye and the control eye (P>0.20 for all). There was a significant correlation between lens-wearing eye and control eye (r=0.895, P<0.001) and between lotrafilcon A and each of the other 3 lenses for mean CCS across the study participants (P<0.001 for all). CONCLUSIONS: Distribution of corneal swelling in both lens-wearing eye and control eye followed a normal curve. An individual's corneal swelling response seems to be independent of lens type.

Overnight corneal swelling with silicone hydrogel contact lenses with high oxygen transmissibility.

PURPOSE: To compare central corneal swelling after 8 hours of sleep in eyes wearing 2 different silicone hydrogel lenses with high oxygen transmissibility. METHODS: Twenty neophyte subjects were randomly assigned to wear a comfilcon A lens (CooperVision Inc) in one eye and a lotrafilcon A lens (CIBA Vision) in the contralateral eye for an 8-hour overnight period. The study was repeated with another 20 neophyte subjects wearing comfilcon A in one eye only and no lens in the contralateral control eye. Central corneal thickness was measured with optical pachometry before lens insertion, immediately after lens removal on waking, at 20 and 40 minutes, 1 hour, 2 hours and 3 hours. RESULTS: There was no significant difference between the amount of overnight central corneal swelling induced by the 2 lenses (4.1% +/- 1.9% with comfilcon A vs. 4.0% +/- 1.7% with lotrafilcon A; P>0.05). The swelling of the comfilcon A lens-wearing eyes was significantly higher than that found in the non-lens-wearing contralateral eyes (4.5% +/- 2.1% vs. 3.0% +/- 1.7%; P<0.05). CONCLUSIONS: The same amount of overnight corneal swelling was induced by the 2 study lenses. The higher overnight swelling observed with the comfilcon A lenses compared to the non-lens-wearing eyes is similar to that reported in the literature for studies using lotrafilcon A lenses.

Novel pachometry calibration.

PURPOSE: The purpose of this study was to develop a simple method for cross-calibrating instruments that measure corneal thickness. METHODS: Fourteen rigid lenses of different thicknesses were manufactured using a material with refractive index of 1.376. Center thickness of the lenses (CT) was measured using a computerized optical pachometer (OP), two optical coherence tomographers (OCTs), and a confocal microscope (CM). Accuracy of measurements was compared between the four instruments. RESULTS: Before calibrating the machines, there was a significant effect of the measurement device (p < 0.05). The differences between instruments were eliminated (p > 0.05) after applying calibration equations for each device. In addition, after each instrument was calibrated with lenses of 1.376 refractive index, there was no significant difference (p > 0.05) between measured values of lens center thickness by OP, each OCT, CM, and the physical center thickness of the lenses. CONCLUSIONS: Using calibration lenses with the same refractive index as the cornea (1.376) allows rapid and simple calibration of the pachometers so that corneal thickness measurements from different devices can be used interchangeably.

Contact lens-induced corneal swelling and surface changes measured with the Orbscan II corneal topographer.

PURPOSE: The purpose of this study was to measure central and topographical corneal swelling in response to contact lens wear and eye closure, to determine whether the swelling induced by soft and polymethyl methacrylate (PMMA) lenses is different, and to determine whether the anterior and/or posterior corneal shape alters with corneal swelling. METHODS: An Orbscan II corneal topographer was used to measure corneal swelling and the shape of the anterior and posterior corneal surfaces of 16 neophytes before and after wearing soft and PMMA contact lenses with near-zero oxygen transmissibility. The lens-wearing eye was patched for 3 h. RESULTS: The mean 15.1% +/- 3.8% (+/- SD) central corneal swelling with soft lenses was significantly >12.6% +/- 4.1% with PMMA lenses. Topographical corneal swelling was significantly greater with soft vs. PMMA lenses. However, the difference between central and peripheral corneal swelling was much greater with PMMA lenses. With both lenses, the cornea swelled significantly more in the center than the periphery. The anterior best-fit sphere radius remained unchanged in response to soft lenses (0.00 +/- 0.04 mm) and steepened slightly but significantly with PMMA lenses (-0.04 +/- 0.05 mm). The posterior best-fit sphere radius flattened significantly with both lenses (0.12 +/- 0.07 mm with soft and 0.14 +/- 0.08 mm with PMMA lenses). CONCLUSIONS: Corneal swelling (greater centrally than peripherally) flattens the posterior surface of the cornea and is independent of lens type. Although the anterior best-fit sphere radius steepened with PMMA, the magnitude is probably clinically unimportant. Both lens types produced greater central vs. peripheral corneal swelling. However, the soft lens induced significantly greater overall swelling than PMMA. Because their oxygen transmission was the same, these results suggest that there is lateral diffusion of oxygen from the peripheral area of the cornea (that is not covered by the lens) toward the center.