Initial comfort of lotrafilcon A silicone hydrogel contact lenses versus etafilcon A contact lenses for extended wear.

PURPOSE: To compare the initial comfort afforded by silicone hydrogel lenses (lotrafilcon A) versus the comfort afforded by conventional hydrogel lenses (etafilcon A) in extended wear (EW). DESIGN: Prospective, double-masked and randomized controlled trial. METHODS: Lotrafilcon A and etafilcon A contact lenses were eye randomly fitted on an EW basis for 7 days and nights in 20 subjects. A forced-choice subject preference questionnaire was made. Subjects were comfort, dryness, red eye and visual quality after night wear and at the end of the day. Subjective scored satisfaction (scale: 1-5) and lens preference were assessed. RESULTS: Lotrafilcon A proved more comfortable after night wear (60%, CI95% 38-82%) and at the end of the day (70%, CI95% 49-90%) than etafilcon A after night wear (10%, CI95% 0-23%, P<0.05) and at the end of the day (20%, CI95% 2-38%, P<0.05). The feeling of dryness was more marked with etafilcon A after night wear (50%, CI95% 27-72%) and at the end of the day (50%, CI95% 27-72%) than it was with lotrafilcon A (15%, CI95% 0%-31%) after night wear (P>0.05) and at the end of the day (25%, CI95% 5%-44%, P<0.05). General satisfaction with the lotrafilcon A lens was 3.65 points (CI95% 3-4.2) and with etafilcon A 2.95 points (CI95% 2.5-3.3, P<0.05). Eighty percent (CI95% 62%-98%) of subjects preferred lotrafilcon A (P<0.05) for EW. CONCLUSIONS: In EW, lotrafilcon A contact lenses were more comfortable and led to less dryness after night wear and at the end of the day than etafilcon A contact lenses.     

Ocular physiology and comfort in neophyte subjects fitted with daily disposable silicone hydrogel contact lenses

PurposeTo evaluate the performance of a silicone hydrogel daily disposable lens in neophyte subjects over 12 months.MethodsSeventy four subjects with no previous contact lens experience were randomised to wear narafilcon A (1 DAY ACUVUE^® TruEye™) lenses (LW group) or to wear no contact lenses (NLW group) for 12 months. Biomicroscopy (performed by a masked investigator), visual acuity and subjective response scores were recorded at an initial visit and six follow-up visits, in addition to lens fit and surface evaluation for the LW group. Comfort was recorded with SMS messaging.ResultsFifteen of the LW group discontinued before the end of the study, compared with six of the NLW group. Measured visual acuity was about half a line better for the NLW group as these subjects were provided with their full sphero-cylindrical over-refraction, compared to the LW group in their best spherical corrected contact lenses; subjective scores for vision were similar for the two groups. Bulbar conjunctival hyperaemia, limbal hyperaemia, corneal staining, conjunctival staining and papillary conjunctivitis were clinically equivalent for the two groups whereas conjunctival staining was higher in the LW group. Comfort scores assessed by SMS were equivalent for the LW and NLW groups; there was a measurable improvement in comfort during the first month of wear for the LW group.ConclusionThis work has demonstrated that modern soft lenses (narafilcon A daily disposable silicone hydrogel lenses) offer an excellent, comfortable form of vision correction, and are able to exhibit minimal alterations to ocular physiology.     

In-vitro dewetting properties of planned replacement and daily disposable silicone hydrogel contact lenses

AimTo compare the in-vitro videokeratoscopic surface dewetting properties of new-generation silicone hydrogel (SiH) planned replacement contact lenses (CL) with those of daily disposable CLs.MethodA chrome coated cornea model was used for the in-vitro evaluation of surface dewetting. Pre-lens and post-lens film layers were formed by instilling a normal preservative-free normal saline solution (PFNs) (0.9 %) before and after the placement of the CL on the model cornea. The tests were carried out on fanfilcon A, lotrafilcon B, samfilcon A, and senofilcon A lenses, as well as such daily disposable lenses as delefilcon, nesofilcon A and senofilcon one day. Using videokeratoscopic methods, images were obtained at 30-second intervals up to 180 s in the lens and control groups and were analyzed by the ImajeJ® program.ResultsThe mean measured area of the keratoscopic rings was largest in the fanfilcon group (67.56 mm²), followed by 61.53 mm² in the lotrafilcon A group and 64.60 mm² in the samfilcon group, while the smallest area was measured in the senofilcon A group, at 56.90 mm². The area was measured as 64.33, 63.09 and 68.39 mm² for the delefilcon, nesofilcon and Senofilcon one day CLs, respectively. The dewetting patterns and properties differed in the CL groups (p < 0.05), while no significant differences were found between the measured areas of the planned replacement and daily disposable CL groups (p > 0.05).DiscussionVideokeratoscopy using in-vitro cornea models has been identified as a reproducible and reliable method for the analysis of the surface dewetting of CLs. The dewetting characteristics of CL groups have been found to differ from each other, despite all being produced from SiH materials. The surface wetting coating has been shown to affect CL dewetting performance.     

Randomized crossover trial of silicone hydrogel contact lenses

PurposeThe aim of the current study is to assess, using new technologies, the interaction of four monthly silicone hydrogel contact lenses on the ocular surface and the comfort over 15 days of use.MethodsProspective cross-over, randomized and double-masked study including four materials (lotrafilcon-B, samfilcon-A , comfilcon-A and filcom-V3). Clinical examination was performed in the following order: tear meniscus height, first break-up of the tear film, the average time of all tear film breakup incidents, bulbar redness, limbal redness (Keratograph 5M ,Oculus, Germany); central corneal thickness (Pentacam, Oculus, Germany), thermography values (FLIR A325; FLIR Systems Inc., USA), and slit-lamp evaluations, including ocular surface staining. Finally, subjective comfort was obtained from Contact Lens Dry Eye Questionnaire-8.ResultsThe impact of contact lens wear on the ocular surface didn’t show statistically significant changes over time except for corneal and conjunctival staining grades on day 15 compared to day 1 for the comfilcon A group (P = .003 and P = .01, respectively). Contact lens stability and impact on the ocular surface during contact lens wear didn’t show statistically significant changes over time except in the case of the comfilcon A material with respect to the irritation item (P = .01).ConclusionsThese results suggest that the impact of monthly silicone hydrogel contact lens materials on the ocular surface after and during contact lens wear, contact lens stability over time, and subjective comfort did not reveal any significant changes over 15 days of use for any of the materials.     

Novel in vitro method to determine pre-lens tear break-up time of hydrogel and silicone hydrogel contact lenses

PurposeTo develop an in vitro model to determine pre-lens non-invasive break-up time (NIBUT) and to subsequently use this method to compare the NIBUT over contemporary daily disposable (DD) contact lenses (CL).MethodsThree silicone hydrogel (SH) and two conventional hydrogel (CH) DD CLs were incubated in an artificial tear solution (ATS). A model blink cell (MBC) was utilised to mimic intermittent air exposure. CLs were repeatedly submerged for 3 seconds (s) and exposed to air for 10 s over periods of 2, 6, 12, and 16 hours (h). NIBUTs (n = 4) were determined out of the blister pack (T₀) and at the end of each incubation period.ResultsOverall, nesofilcon A showed the longest NIBUTs (p < 0.001). At T₀, CHs revealed significantly longer NIBUTs (p ≤ 0.001) than SHs. After 2 h, nesofilcon A showed the longest NIBUT, however, this was only statistically significant compared with delefilcon A (p ≤ 0.001). After 6 h, nesofilcon A NIBUT was significantly longer than all other CLs (p ≤ 0.001). Etafilcon A showed a significantly longer NIBUT (p ≤ 0.001) after 12 h and delefilcon A had the longest NIBUT (p ≤ 0.001) after 16 h. Statistically significant (p ≤ 0.05) changes of NIBUT within the lens materials varied between time points. After 16 h, all CLs showed significant reductions in NIBUTs (p ≤ 0.001) in comparison to T₀.ConclusionNIBUT values reduced gradually over time and varying levels of deposition impacted measured pre-lens NIBUTs. While NIBUT of CH materials are longer immediately out of the blister pack, after tear film exposure, the NIBUTs obtained using this methodology became very similar.     

Corneal shape changes induced by first and second generation silicone hydrogel contact lenses in daily wear

Purpose

To compare the corneal topographical changes induced by two first and second generation silicone-hydrogel (SiH) contact lenses after 3 months of daily wear (DW).

Methods

Prospective, consecutive case-series in which patients wore one of 3 different contact lenses (either the first generation SiH Focus Night & Day, the second generation SiH Acuvue Oasys or the monthly disposable Soflens 38 hydrogel lens as control group) on a DW basis for 3 months. Over-refraction, visual acuity, mean keratometry, corneal astigmatism, corneal eccentricity, superficial regularity and superficial asymmetry indices were monitored over the 3-month period.

Results

Nineteen eyes of 10 patients completed the study. Seven Focus Night & Day, 7 Acuvue Oasys and 5 Soflens 38 contact lenses were fitted. There were no significant changes between any of the parameters measured at the 3-month visit in any of the SiH groups (non-parametric Wilcoxon test, p > 0.05). However, the control group (Soflens 38) showed statistically significant changes regarding mean keratometry, corneal astigmatism and corneal eccentricity (p < 0.05). Three patients wearing the first generation SiH showed adverse events of different degree related to their high modulus of elasticity.

Conclusions

After 3 months of DW, wearers of first and second generation SiH lenses showed greater corneal stability than hydrogel monthly disposable contact lenses users regarding commonly used topographic corneal shape indices. However, complications related to the mechanical properties of first generation SiH were seen in three patients in the follow-up time.     

Trends in the use of silicone hydrogel contact lenses for daily wear

Although the first silicone hydrogel contact lenses introduced onto the world contact lens market in 1999 held approval for both daily wear and extended wear use, the latter modality was promoted much more heavily by the manufacturers. The first silicone hydrogel lenses specifically promoted for daily wear were introduced in 2003. Data that we have gathered from annual contact lens fitting surveys demonstrate an immediate increase in market share whereby this lens type now represents more than one-third of soft lens fits in the United Kingdom. The success of this lens category is attributed to the health and safety benefits of silicone hydrogel materials and the positive impact of lens manufacturers by way of the effective marketing and distribution of these products.     

Masked comparison of two silicone hydrogel bandage contact lenses after photorefractive keratectomy

PurposeTo compare the efficiency and safety of two bandage contact lenses after photorefractive keratectomy (PRK).MethodsIn this double-blind study, 45 patients (90 eyes) received PRK in both eyes and wore bandage contact lenses (BCLs), PureVision (Bausch & Lomb, Rochester, NY, USA) in one eye and PureVision2 (Bausch & Lomb, Rochester, NY, USA) in the other eye, randomly assigned. The medication regimen after surgery was the same for both eyes. The epithelial defect's size, conjunctival hyperemia and lens centration were graded objectively using slit-lamp biomicroscopy on days 1, 3 and 5 after surgery. Also ocular symptoms of discomfort including tearing, photophobia, foreign body sensation and visual fluctuations were assessed subjectively at each visit.ResultsThe mean epithelial defect size on the first day after operation was similar in eyes fitted with PureVision (30.08 ± 5.30 mm²) and PureVision2 (30.25 ± 5.72 mm²) lenses. (p = 0.79) Contact lens deposits and bulbar hyperaemia on days 1 and 3 after PRK were similar between the two eyes, but were significantly greater on day 5 for PureVision2 lenses. (p = 0.02; p = 0.04 respectively) There was no difference in contact lens decentration, and discomfort symptoms including pain, tearing, foreign body sensation, photophobia and visual fluctuations between the eyes fitted with PureVision and PureVision2. (p > 0.05)ConclusionsPureVision and PureVision2 contact lenses are equivalent as bandage lenses in important aspects such as corneal re-epithelialization and subjective comfort., although PureVision2 led to a higher incidence of contact lens deposits and conjunctival hyperemia early post-PRK.     

Uptake and release of polyhexamethylene biguanide (PHMB) from hydrogel and silicone hydrogel contact lenses using a radiolabel methodology

PurposeThe purpose of this study was to evaluate the uptake and release of radiolabelled polyhexamethylene biguanide (PHMB) on reusable daily wear contact lenses (CLs) over 7 days.MethodsThree silicone hydrogel (SH) contact lens materials (lotrafilcon B, balafilcon A, senofilcon A) and two conventional hydrogel (CH) materials (etafilcon A, omafilcon A) were examined. In experiment 1 (1-day study), CLs were soaked in 2 mL of phosphate buffered solution (PBS) containing radiolabelled ¹⁴C PHMB (1 µg/mL) for 8 h. The release kinetics of ¹⁴C PHMB from the CLs was measured at t = 0.25, 0.5, 1, 2, 4, 8, and 24 h in fresh 2 mL PBS. In experiment 2 (7-day study), the CLs were soaked in the ¹⁴C PHMB (1 µg/mL) solution for 8 h followed by a 16-hour release in 2 mL PBS. The lens cycle was repeated daily for 7 days. After both experiments, the residual amount of PHMB remaining within the lenses was extracted to determine the total uptake of PHMB.ResultsIn experiment 1, the total uptake of PHMB for etafilcon A was significantly greater than senofilcon A (p = 0.01). There were no significant differences in total uptake of PHMB between other lens materials (p > 0.05). Etafilcon A released more PHMB compared to all other lens types over a 24-hr period (p < 0.001). In experiment 2, all CL materials continued to sorb more PHMB over time (p < 0.001). By day 7, the amount of PHMB sorbed by etafilcon A was significantly greater than senofilcon A (p = 0.02). After day 2, the CH materials released significantly more PHMB than the SH materials (p < 0.01).ConclusionThe CL materials continued to sorb PHMB with no signs of saturation after 7 days. All lens materials released a consistent amount of PHMB each day. Radioactive labelling provides a sensitive method of assessing the uptake and release of PHMB from CL materials.     

The effect of hydrogel and silicone hydrogel contact lenses on the measurement of intraocular pressure with rebound tonometry

Purpose

To assess the accuracy of intraocular pressure (IOP) measurements using rebound tonometry over disposable hydrogel (etafilcon A) and silicone hydrogel (senofilcon A) contact lenses (CLs) of different powers.

Methods

The experimental group comprised 36 subjects (19 male, 17 female). IOP measurements were undertaken on the subject's right eyes in random order using a rebound tonometer (ICare). The CLs had powers of +2.00D, −2.00D and −6.00D. Six measurements were taken over each contact lens and also before and after the CLs had been worn.

Results

A good correlation was found between IOP measurements with and without CLs (all r ≥ 0.80; p < 0.05). Bland Altman plots did not show any significant trend in the difference in IOP readings with and without CLs as a function of IOP value. A two-way ANOVA revealed a significant effect of material and power (p < 0.01) but no interaction. All the comparisons between the measurements without CLs and with hydrogel CLs were significant (p < 0.01). The comparisons with silicone hydrogel CLs were not significant.

Conclusions

Rebound tonometry can be reliably performed over silicone hydrogel CLs. With hydrogel CLs, the measurements were lower than those without CLs. However, despite the fact that these differences were statistically significant, their clinical significance was minimal.     

The accuracy of Goldmann applanation tonometry over silicone hydrogel contact lenses in patients with glaucoma

PurposeTo investigate the accuracy of measuring intraocular pressure over a silicone hydrogel contact lens using Goldmann applanation tonometry in eyes with glaucoma.MethodsThis was a prospective, randomized study and enrolled 28 patients (28 right eyes) with primary open angle glaucoma. Intraocular pressure was taken with and without a silicone hydrogel contact lens (−0.50 D), in situ (using Goldmann applanation tonometry), in a randomized order of measurements. Statistical analysis was performed using paired t-test and Bland–Altman plot.ResultsThe mean difference (± standard deviation) found between intraocular pressure measurement without (mean 16.7 ± 3.2 mmHg) and with (mean 17.3 ± 3.0 mmHg) contact lens was found to be −0.57 ± 2.3 mmHg (95% confidence interval, −1.5 to 0.3). No significant statistical difference was found between the two groups with paired t-test (p = 0.19). The Bland Altman plot showed some evidence of increasing variability of differences between two measures of intraocular pressure, with increasing intraocular pressure. The 95% limits of agreement of the Bland Altman plot were unacceptably large (−5 mmHg to 3.9 mmHg).ConclusionAgreement between Goldmann applanation tonometry with and without contact lenses seems to be poor in patients with glaucoma, especially for high intraocular pressure.     

Ultraviolet (UV) transmittance characteristics of daily disposable and silicone hydrogel contact lenses.

The ultraviolet (UV) transmittance spectra of daily wear hydrogel and disposable silicone hydrogel contact lenses were measured. Average transmittance percentages were calculated for each lens for the entire UV spectrum and individually for the UVC, UVB and UVA portions of the spectrum. The significance of the differences in transmittance spectra obtained for the lenses was analysed using a one-way ANOVA planned comparisons test (alpha=0.05). The transmittance data were then used to calculate a UV protection factor (PF) for each contact lens brand tested. The PFs for 1-DAY ACUVUE MOIST (6.22), ACUVUE ADVANCE (10.02) and ACUVUE OASYS (11.96) contact lenses show that these contact lenses have superior UV-blocking capabilities. The PFs for Focus DAILIES (1.79), SofLens 1-day disposables (1.72), NIGHT & DAY (1.84), O2 Optix (1.99) and Purevision (2.62) show that these contact lenses posses more modest UV-blocking characteristics. This paper reviews the importance of protection of the anterior ocular surface from UV damage and quantifies the protection afforded by selected commercially available disposable contact lenses.     

Eye care professionals’ perceptions of the benefits of daily disposable silicone hydrogel contact lenses

PurposeTo gain a better understanding of eye care professionals’ (ECPs) perceptions regarding the benefits of silicone hydrogel (SiH) daily disposable contact lenses (DDCL), particularly with respect to health, comfort and patient satisfaction.MethodsA survey was conducted with 300 ECPs in the United States, United Kingdom and Japan during November 2017. The survey comprised 34 statements relating to SiH DDCLs, to which the ECPs provided their level of agreement using a 6 point Likert scale. A minimum of 70% agreement was set to define majority agreement. Categories of statements included Health, Comfort, Patient Experience, and Standard of Care.ResultsECPs rated the highest levels of agreement to perceptions within the Patient Experiences and Health categories. The six statements receiving the highest ratings were “Silicone hydrogel 1 day lenses satisfy today’s patients’ demanding lifestyles” (93% agreement); “Silicone hydrogel 1 day lenses are the best choice to safeguard my patients’ eye health related to contact lens wear” (92%); “Silicone hydrogel 1 day lenses provide the best benefits to my patients” (92%); “Silicone hydrogel 1 day lenses provide better long term eye health for my patients than hydrogel 1 day lenses” (91%); “Silicone hydrogel is the healthiest lens material for my daily disposable patients” (90%); and “Silicone hydrogel 1 day lenses provide a better wearing experience for my patients than hydrogel 1 day lenses” (90%).ConclusionECPs perceive that SiH DDCLs offer long-term eye health and comfort for the patient and although the ECPs surveyed would not necessarily prescribe SiH DDCLs to all their patients, they would prescribe them to most of their patients. The results support the premise that while ECPs consider SiH 1 day contact lenses as the current “standard of care”; the principal barrier continues to be the perceived higher cost of these lenses.