Visual performance of optical films utilizing Spatio-Temporal Optical Phase technology.

SIGNIFICANCE: Spatio-Temporal Optical Phase technology utilizes film pairs containing optical elements applied to standard single-vision spectacle lenses. This technology provides a dynamic optical cue that may have efficacy in reducing the rate of myopia progression, but the visual performance of this technology is unknown. PURPOSE: This study aimed to assess the visual performance of film pairs containing optical elements (tests) and a film pair with no optical elements (control). METHODS: In this randomized, single-masked, bilateral wear study, 42 participants aged 18 to 40 years wore four test designs (E, F-1, G, and F-2) and the control. Subjective data (subjective ratings [1 to 10 scale]: clarity of vision [far-away, intermediate, near] and vision [at night, while walking, overall satisfaction], and willingness to purchase [yes/no response]) were collected after 3 days. Visual acuity (VA)-based measures (monocular high/low-contrast VA [6 m], contrast sensitivity [6 m], and binocular high-contrast VA [6 m and 40 cm]) were collected at dispensing. Visual acuity-based measures were also collected while wearing spectacles with no film. Analyses were performed using linear mixed models and the χ2 test. Significance was set at 5%. RESULTS: The control performed better than any test for all subjective ratings (mean differences, 1.6 to 3.1 units: p<0.001), willingness to purchase (p<0.001), and designs F-1 and F-2 for binocular high-contrast VA at 40 cm (p=0.001 and p=0.01, respectively). Clarity of vision was significantly worse with F-2 compared with F-1 and G (p<0.001 and p=0.02, respectively). There were no differences between tests for any other subjective rating (p>0.1), willingness to purchase (p=0.11), or any VA-based measure (p>0.08). There were no differences between control and spectacles with no film for any VA-based measure (p>0.08). CONCLUSIONS: All four test film pairs reduced visual performance compared with control to a degree comparable with other myopia management devices. There was no difference in visual performance between three of the four test film pairs.

Visual Performance and Binocular/Accommodative Function of S.T.O.P. Contact Lenses Compared With MiSight.

OBJECTIVES: The objective of this study was to compare the visual performance and binocular/accommodative function of two novel S.T.O.P. design (F2 and DT) contact lenses against MiSight when worn by myopic, young adults. METHOD: This was a prospective, randomized, cross-over, single-masked study. Each lens was worn daily wear with overnight peroxide disinfection for approximately 7 days. Visual performance was assessed with subjective ratings (0-100): clarity of vision and lack of ghosting (far away, intermediate, and near), vision when driving, overall vision satisfaction, and with monocular high-contrast and low-contrast visual acuity (HCVA/LCVA) at 6 m, binocular HCVA (6 m, 70 cm, 50 cm, and 40 cm), binocular LCVA (6 m and 70 cm). Binocular function was assessed with heterophorias (3 m and 40 cm). Accommodative function was assessed with monocular accommodative facility (AF: 40 cm) and dynamic monocular accommodative response (AR: 6 m, 70 cm, and 40 cm). RESULTS: F2 was rated higher than MiSight for clarity of vision (near and intermediate) and lack-of-ghosting ( P <0.001), while MiSight was rated higher than DT for clarity of vision (near, P <0.001). MiSight was better than F2 and DT for monocular HCVA (6 m) and binocular HCVA (6 m and 40 cm, P ≤0.02), but the maximum difference was ≤2 letters. There were no differences between designs for heterophoria ( P =0.61) nor were there any differences between DT and MiSight for any accommodative measure ( P >0.1). F2 was higher for monocular-AF ( P =0.007) and lower for AR (70 cm and 40 cm; P ≤0.007) compared with MiSight. CONCLUSIONS: The visual performance and binocular/accommodative function of S.T.O.P. designs F2 and DT were comparable with MiSight. F2 outperformed MiSight in some aspects of subjective visual performance and monocular accommodative function.

The Relationship Between Vision and Comfort in Contact Lens Wear.

OBJECTIVE: Understand relationship between vision and comfort in contact lens (CL) wear. METHODS: Retrospective analysis of five trials using similar protocols with nonpresbyopic (NP) myopes or presbyopic participants (Px) wearing various simultaneous-image designs (SM) and single-vision (SV) CL (NP only). Questionnaires (vision satisfaction, vision clarity: distance/intermediate/near, comfort) on 1 to 10 scale were administered 1 week after fitting. Vision/comfort relationship was analyzed using linear mixed model and presented as regression coefficient with 95% confidence intervals (CIs). RESULTS: Vision ratings correlated with comfort ratings, although this varied depending on type of vision rating and Px category. Vision satisfaction influenced comfort for the NP-SV group (slope: 0.8; 95% CI: 0.58-1.01, P≤0.001), but was significantly lower in the presbyopic group (slope: 0.38; 95% CI: 0.33-0.42; P≤0.001). Controlling for lens material obtained similar results. In the reverse relationship, comfort had a significant impact on vision satisfaction, although again at varying levels for each Px group. NP-SV demonstrated the weakest relationship (slope: 0.47; 95% CI: 0.35-0.59, P≤0.001) in comparison to NP-SM and P-SM groups. CONCLUSION: Vision and comfort in CL wear are inter-related. Consideration of Px characteristics, visual stimulus, and CL comfort needs to be accounted for when assessing overall CL experience.

The Relationship between Visual Acuity, Subjective Vision, and Willingness to Purchase Simultaneous-image Contact Lenses.

SIGNIFICANCE: This study reports that subjective vision ratings are better indicators of willingness to purchase simultaneous-image contact lenses than visual acuities and are more valuable in evaluating contact lens performance. PURPOSE: The purpose of this study was to investigate the relationship between visual acuities, subjective vision ratings, and willingness to purchase simultaneous-image contact lenses in presbyopes. METHODS: A retrospective analysis of visual acuities, subjective vision ratings, and willingness to purchase from final visits of two masked, crossover clinical trials of nine prototype and four commercially available simultaneous-image contact lenses in 141 presbyopes was performed. Pearson correlation and area under the receiver operating characteristic curve determined correlations between variables. RESULTS: Most subjective vision ratings were weakly correlated (r < 0.3) with visual acuity at all distances and illumination. Moderate correlations (r, 95% confidence intervals) were found between overall vision satisfaction ratings with visual acuity at 40 (-0.34, -0.28 to -0.40) and 50 cm (-0.33, -0.27 to -0.39), near-vision ratings (daytime) with visual acuity at 40 (-0.48, -0.43 to -0.53) and 50 cm (-0.46; -0.41 to -0.51), and intermediate-vision ratings (daytime) with visual acuity at 40 (-0.39, -0.33 to -0.45) and 50 cm (-0.41, -0.35 to -0.46). Highest discrimination for willingness to purchase was with overall vision satisfaction (area under curve, 0.93) and vision stability (daytime; area under curve, 0.77). Ratings from 4 to 9 for vision satisfaction showed a linear increase in willingness to purchase: a 1-unit increase in vision satisfaction increased willingness to purchase by 20%. Ratings lower than 4 had 0% willingness to purchase. Other subjective ratings showed similar relationships, albeit only 10 to 15% increase in willingness to purchase per unit increase for ratings higher than 4. CONCLUSIONS: Subjective vision ratings are a better indicator of simultaneous-image contact lens performance than visual acuity. Overall vision satisfaction and vision stability are key predictors of willingness to purchase. Subjective vision ratings should be used to evaluate performance rather than visual acuity alone.

Subjective Ratings and Satisfaction in Contact Lens Wear.

SIGNIFICANCE: This study shows satisfaction in contact lens (CL) wear is influenced by both comfort and vision. Eighty-six percent of participants were willing to continue with trial CL wear if satisfied with both comfort and vision, dropping to 50% if either variable was unsatisfactory and 0% if both were unsatisfactory. PURPOSE: The aim of this study was to understand the relationship between subjective ratings and satisfaction with CL wear. METHODS: This was a retrospective analysis of two daily-disposable CL trials (delefilcon A, somofilcon A) on participants 40 years or younger followed over 3 months. Subjective ratings (numerical rating scale 1 to 10, 1-point step) collected at visits following baseline (2 weeks, 1 and 3 months) included comfort (insertion, during day, end of day), vision clarity, and binary response for satisfaction with comfort and vision (yes/no). Willingness to continue with trial CL was obtained at completion. RESULTS: There was no significant association of comfort on insertion with comfort satisfaction (odds ratio [OR], 1.2; P = .30); however, comfort during day (OR, 2.1; P < .001) and end of day (OR, 3.4; P < .001) was associated with comfort satisfaction. For comfort during day ratings of at least 8/10 and end of day of at least 6/10, 90% of participants were considered satisfied. There was a 14% increase in participants satisfied with comfort for each unit increase on the numerical rating scale from ratings of 3 to 8 for comfort during day and a 20% increase from ratings of 3 to 7 for comfort end of day. The percentage of satisfied participants reached its maximum at a lower end of day rating (8/10) compared with during day (10/10). The percentage of participants satisfied with vision reached its maximum (100%) at a vision rating of 9/10. CONCLUSIONS: Satisfaction in CL wear is influenced by both comfort and vision. A higher rating for comfort during the day compared with end of day is necessary for participants to attain satisfaction.

Measuring Daily Disposable Contact Lenses against Nonwearer Benchmarks.

SIGNIFICANCE: Since becoming a popular form of refractive error correction, contact lenses have aspired to replicate the nonwearer experience. This study assessed how well currently available daily disposable soft lenses have achieved that goal, using a graphical representation to show individual lens behavior relative to benchmarks. PURPOSE: The purpose of this study was to assess comfort, vision, and adverse events during daily disposable contact lens wear, relative to emmetropes and spectacle wearers. METHOD: Three-month clinical studies, where participants either wore one of five daily disposable contact lenses (n = 201), were full-time spectacle wearers with no history of contact lens wear (n = 34), or emmetropic non-contact lens wearers (n = 40). Vision quality and comfort were assessed at the beginning and end of the day (1 to 10). Corneal infiltrative events were recorded. Between-group comparisons were made using a linear mixed model and literature estimates of clinical significance. RESULTS: Initial comfort among emmetropes (mean ± 95% confidence interval, 8.0 ± 0.5) was not significantly different from any of the lens types (range, 7.2 ± 0.4 to 8.0 ± 0.4, all P > .06) or spectacle wearers (7.3 ± 0.5, P = .45). Comfort deteriorated during the day in all groups (P < .05). End-of-day comfort for emmetropes (7.3 ± 0.6) was significantly better, only than lenses B (5.7 ± 0.6, P < .001) and D (6.2 ± 0.5, P = .01). Vision quality for emmetropes (8.6 ± 0.5) was better than spectacle wearers (7.8 ± 0.5, P = .04) and lenses A (7.6 ± 0.4, P = .003) and B (7.5 ± 0.4, P < .001). Corneal infiltrative events occurred in 0% of emmetropes and 2.9% of spectacle wearers and ranged from 2.4 to 7.5% in lens wearers. CONCLUSIONS: Under the conditions of this study, comfort and vision with some contemporary daily disposable contact lenses were indistinguishable from nonwearing emmetropes. Although the contact lens-wearing groups had rates of corneal infiltrative events that were not statistically different from the nonwearers, the study had insufficient power to permit robust conclusions in this respect.

Visual Performance of Daily-disposable Multifocal Soft Contact Lenses: A Randomized, Double-blind Clinical Trial.

SIGNIFICANCE: The present study highlights the differences between modern daily-disposable multifocal soft contact lenses to assist eye care practitioners in fitting presbyopic contact lens wearers. PURPOSE: The purpose of this study was to compare visual performance of three daily-disposable multifocal contact lenses. METHODS: Presbyopes (n = 72) wore 1-Day Acuvue Moist Multifocal, BioTrue ONEday for Presbyopia, and Dailies AquaComfort Plus Multifocal for 1 week in a prospective, randomized, double-blind, crossover clinical trial. After 1 week, high- and low-contrast visual acuities (HCVA, LCVA) were measured between 6 m and 40 cm and stereopsis at 40 cm. Subjective performance was assessed with 1- to 10-point rating scales for clarity, ghosting, driving vision, vision stability, ease of focusing, overall vision satisfaction, and ocular comfort. Willingness to purchase was reported with categorical responses. Linear mixed models and χ tests were used for analysis, and level of significance was set at 5%. RESULTS: BioTrue provided better HCVA and LCVA at distance than did Acuvue Moist (P ≤ .03). Subjectively, Acuvue Moist was rated lowest for distance clarity, distance ghosting, and driving vision (P ≤ .05). Acuvue Moist provided better HCVA at 70 to 40 cm and LCVA at 1 m to 40 cm than did BioTrue (P ≤ .01) and better LCVA at 1 m to 50 cm than did AquaComfort Plus (P ≤ .02). AquaComfort Plus also provided better HCVA and LCVA at 50 and 40 cm than did BioTrue (P ≤ .03). Acuvue Moist provided better stereopsis than did BioTrue (P = .02). Subjectively, BioTrue was rated lowest for near clarity (P ≤ .007) and lower than Acuvue Moist for intermediate clarity and near ghosting (P ≤ .04). No other differences were found between lenses (P > .05). CONCLUSIONS: BioTrue had better distance performance compared with near, whereas Acuvue Moist performed conversely. AquaComfort Plus performed reasonably overall.

Comparison of Silicone Hydrogel and Hydrogel Daily Disposable Contact Lenses.

OBJECTIVE: To compare subjective, objective and safety performance of silicone hydrogel (SiHy) daily disposable (DD) with hydrogel (Hy) DD contact lenses. METHOD: Retrospective analysis on approximately 40 participants (Px) each in 5 trials. Lenses grouped into SiHy (delefilcon A, somofilcon A, narafilcon A) and Hy (omafilcon A, nelfilcon A). Participants attended follow-up visits at baseline, 2 weeks, 1 and 3 months. Subjective ratings (1-10 scale), adverse events (percentage of Px), physiological variables (0-4 scale), and wearing time were collected at each visit and compared between groups. RESULT: Trials enrolled 201 Px totally. No differences in age, sex, and lens wear experience were found between SiHy and Hy groups (P≥0.09). There was greater increase in limbal redness from baseline in Hy group (0.18±0.38 vs. 0.02±0.47, P<0.001), whereas conjunctival staining and indentation were less in Hy group (P<0.001). No differences in comfortable wearing time were found between groups (P=0.41), and comfort at insertion, during day, and end of day was also no different (P≥0.71). Incidence of corneal infiltrative events (SiHy vs. Hy: 6.7% vs. 2.5%; P=0.32) and mechanical adverse events (SiHy vs. Hy: 0.0% vs. 0.0%; P=1.00) were no different. CONCLUSION: Though some statistical significance was found between the groups, these differences were within measurement error. Neither material types showed superiority in comfort, and adverse event rates were low with both material types. These findings suggest that choice of material is a patient and practitioner preference; however, for patients at risk of hypoxia-related complications, SiHy materials should be considered.

Predicting Short-Term Subjective Vision Performance of Contact Lenses Used in Myopia Control.

OBJECTIVE: To investigate whether initial assessment of contact lenses prescribed for myopia control (MC) predicts short-term visual performance. METHOD: Retrospective analysis of 43 participants in a double-masked, randomized, cross-over trial wearing at least one lens: single-vision (SV) lens (1-DAY ACUVUE MOIST) or MC lenses (MiSight or Proclear Multifocal-Distance +2.00D). Participants completed questionnaires at the fitting visit, a take-home questionnaire (THQ) 3 days after fitting and finally at the assessment visit (≥5 days after fitting). Questions comprised vision clarity and lack of ghosting (distance, intermediate, near at day/night time); vision stability; driving vision; overall vision satisfaction and comfort (1-10 scale, 1-point steps); and willingness to purchase based on vision and MC benefit of lens (yes/no response). Visual acuity was measured at fitting and assessment visits. RESULTS: Vision clarity (intermediate and near) was significantly worse at assessment compared with fitting while wearing MC lenses (P<0.001), as was overall vision satisfaction (P<0.001), comfort (P<0.001), and vision stability (P=0.001) while wearing either SV or MC lenses. Participants willing to purchase at assessment visit was 84% with SV and 36% with MC lenses, increasing to 88% (SV, P=1.00) and 61% (MC, P<0.001) if the lenses slowed myopia progression. Visual acuity was no different with either MC or SV lenses at fitting or assessment (P≥0.251). CONCLUSION: Initial performance at fitting did not predict short-term performance for SV or MC lenses. A significant increase in willingness to purchase if lenses slowed myopia progression was observed while wearing MC lenses. Educating patients on the benefits might increase acceptability of MC lenses.

Comparison of Extended Depth-of-Focus Prototype Contact Lenses With the 1-Day ACUVUE MOIST MULTIFOCAL After One Week of Wear.

OBJECTIVES: To compare visual performance of extended depth-of-focus (EDOF) prototypes with a new, center-near, commercial, multifocal contact lens. METHODS: Presbyopic participants (n=57) wore 1-Day ACUVUE MOIST MULTIFOCAL (1DAMM) and an EDOF prototype for one week in a double-masked, prospective, cross-over, randomized clinical trial. Manufacturers' guide was used to select the first pair of lens to be fit based on subjective distance refraction and near addition. After one week, high- and low-contrast visual acuities were measured at distance (6 m), intermediate (70 cm) and near (50 and 40 cm), and stereopsis at 40 cm. Subjective performance was assessed on a 1 to 10 numeric rating scale for vision clarity and lack of ghosting at distance, intermediate and near, vision stability, haloes at night time, overall vision satisfaction, and ocular comfort. Linear mixed models were used for analysis and the level of significance was set at 5%. RESULTS: 1DAMM was not significantly different from EDOF for high- or low-contrast visual acuity at any distance, or for stereopsis. Subjectively, EDOF was significantly better than 1DAMM for vision clarity at intermediate (P=0.033) and near (P<0.001), overall lack of ghosting (P=0.012), vision stability (P=0.004), and overall vision satisfaction (P=0.005). For all other subjective variables, there were no differences between EDOF and 1DAMM (P>0.05). CONCLUSIONS: EDOF prototype lenses offer improvements over the newly marketed 1DAMM lenses for several subjective variables.

Predicting Short-term Performance of Multifocal Contact Lenses.

OBJECTIVE: To investigate if initial multifocal contact lens (MFCL) performance predicts short-term dispensing performance. METHODS: A retrospective analysis of 55 participants (Px) in a masked, crossover, clinical trial, using ACUVUE OASYS for Presbyopia and AIR OPTIX AQUA Multifocal. Subjective questionnaires were administered at the following instances: initial fitting, two take home questionnaires (THQ) completed between days 2 and 4 and at assessment, ≥5 days after fitting. Questionnaires included vision clarity and lack of ghosting at distance, intermediate and near at day/night time points rated on a 1 to 10 (1-step, 10 most favorable) rating scale. Vision stability, vision while driving, overall vision satisfaction, willingness to purchase and comfort, as well as acuity-based measures were also collected. RESULTS: There were no statistical differences in comfort and vision at all distances, in vision stability or driving at either time points between THQ and assessment (P>0.05). However, there was a statistical decline in subjective overall vision satisfaction and comfort between fitting and assessment visits (P<0.001). Willingness to purchase remained the same at fitting and assessment in 68% of Px, whereas only 4% of Px converted to a positive willingness to purchase at assessment. The majority of acuity-based measures remained constant between fitting and assessment visits. CONCLUSION: Initial performance at fitting was not able to predict short-term performance of MFCL. Subjective measures peaked at fitting and declined thereafter whereas acuity-based measures remained constant. Utility of subjective rating tools may aid practitioners to gauge success of MFCL.

Combined effect of comfort and adverse events on contact lens performance.

PURPOSE: To report the performance of various contact lenses and lens care solution combinations based on the combined response of subjective comfort and adverse events (AEs). METHODS: A retrospective analysis of 28 lens/solution combinations each tested on approximately 40 participants who wore their assigned combination on a daily wear basis and were followed for a 3-month period, with visits at baseline, 2 weeks, and 1 and 3 months. Lenses included frequent replacement and daily disposables. Solutions included hydrogen peroxide and multipurpose types. Subjective comfort (scale of 1 to 10) and AEs were collected and reported as a group mean and percentage, respectively. The data were converted into a ratio between 0 and 1 to represent the relative performance within the combination series, with a higher ratio indicating better performance in both AE rates and comfort. RESULTS: The overall AE rate was 3.6 events per 100 participant-months (95% confidence interval [95% CI], 2.7 to 4.7%). The rate was found to be lower in daily disposables compared with that in daily wear lenses (3.1 vs. 10.9%, p < 0.001). The overall comfort on insertion rating was 8.3 (95% CI, 8.1 to 8.4), and comfort at end of day was 7.2 (95% CI, 7.0 to 7.4). Based on the 28 lens/solution combinations, there was no significant correlation between overall AE rates and comfort on insertion or at end of day (Pearson correlation, -0.34, p = 0.08; and Pearson correlation, -0.23, p = 0.25, respectively). Less than 18% of the combinations tested combined good comfort with low AE rates. CONCLUSIONS: Both subjective comfort responses and AE rates varied according to the combination of lens type and care system in use. The combinations with the best comfort ratings did not necessarily have a favorable AE rate. Practitioners can maximize behavior with respect to both these factors by choosing an appropriate care system for the lenses they prescribe.

Effect of lens care systems on the clinical performance of a contact lens.

PURPOSE: To evaluate subjective responses, rates of solution-induced corneal staining (SICS), and corneal infiltrative events (CIEs) associated with a silicone hydrogel when worn under a daily disposable (DD) or daily wear (DW) modality. METHODS: Data were obtained from seven prospective clinical trials, involving 283 subjects wearing Senofilcon A contact lenses (Johnson and Johnson Vision Care, Jacksonville, FL). Four groups wore the contact lens on a DW basis using multipurpose solutions (DW-MPS, n = 160), two groups using hydrogen peroxide (DW-H2O2, n = 83), and one group as a DD (n = 40). Participants were followed for 3 months using the same protocol. Subjective ratings were compared between DD and DW groups using a linear mixed model. Rates of SICS and CIE were calculated as the percent frequency of first events within the 3-month study. Association of SICS and CIE with subjective responses was analyzed using a linear mixed model. RESULTS: End-of-day comfort and dryness ratings were significantly better for DD (8.5 ± 1.7 and 8.6 ± 1.7, respectively) compared with DW-H2O2 (7.7 ± 1.8, p = 0.01; 7.6 ± 1.9, p = 0.006, respectively) and DW-MPS (7.7 ± 1.7, p = 0.004; 7.6 ± 2.0, p = 0.003, respectively). Compared with DD, a higher incidence of CIE and SICS was found for DW-MPS (0.0 vs. 3.9%, p = 0.021; 0.9 vs. 8.6%, p = 0.002, respectively). Comfort at insertion and end of day and end-of-day dryness scores were significantly lower for participants who experienced SICS (8.2 ± 1.6, 7.0 ± 1.9, and 7.0 ± 2.2) than those who did not (8.8 ± 1.2, p = 0.004; 7.9 ± 1.7, p = 0.002; and 7.9 ± 1.8, p = 0.003, respectively). Comfort at insertion scores were significantly lower for participants who experienced CIEs than those who did not (8.2 ± 1.5 vs. 8.8 ± 1.4, p = 0.032). CONCLUSIONS: Senofilcon A clinical response is modulated by the lens care products. All lens care products tested reduced subjective responses relative to DD modality, whereas MPS increased the incidence of CIEs and SICS. Senofilcon A performs best when used on a DD basis.

Effect of phospholipid deposits on adhesion of bacteria to contact lenses.

PURPOSE: Protein and lipid deposits on contact lenses may contribute to clinical complications. This study examined the effect of phospholipids on the adhesion of bacteria to contact lenses. METHODS: Worn balafilcon A (n = 11) and senofilcon A (n = 11) were collected after daily wear and phospholipids were extracted in chloroform:methanol. The amount of phospholipid was measured by electrospray ionization mass spectrometry. Unworn lenses soaked in phospholipids were exposed to Pseudomonas aeruginosa and Staphylococcus aureus. After 18 h incubation, the numbers of P. aeruginosa or S. aureus that adhered to the lenses were measured. Phospholipid was tested for possible effects on bacterial growth. RESULTS: A broad range of sphingomyelins (SM) and phosphatidylcholines (PC) were detected from both types of worn lenses. SM (16:0) (m/z 703) and PC (34:2) (m/z 758) were the major phospholipids detected in the lens extracts. Phospholipids did not alter the adhesion of any strain of P. aeruginosa or S. aureus (p > 0.05). Phospholipids (0.1 mg/mL) showed no effect on the growth of P. aeruginosa 6294 or S. aureus 031. CONCLUSIONS: Phospholipids adsorb/absorb to contact lenses during wear, however, the major types of phospholipids adsorbed to lenses do not alter bacterial adhesion or growth.

The clinical performance of lenses disposed of daily can vary considerably.

OBJECTIVES: To evaluate clinical performance of three lens types disposed of on a daily disposable (DD) basis. METHOD: A total of 120 participants were randomized into one of three lens types (etafilcon A, narafilcon A, and senofilcon A), all worn bilaterally on a DD regime. Participants were observed at baseline, 2-week, and 1- and 3-month visits where ocular physiology and lens performance variables were collected on a 0 to 4 grading scale in 0.1 increments. Subjective comfort and vision ratings were collected on a 1 to 100 rating scale and in the form of symptom severity. RESULTS: Forty participants wore each lens type with no differences in age or gender between groups (P>0.05). Etafilcon A exhibited more limbal redness compared with either of the other lens types (P<0.01). More superior corneal staining was noted with narafilcon A lenses compared with senofilcon A (P<0.01), and more superior conjunctival indentation was noted for narafilcon A compared with etafilcon A (P=0.001). No differences were found between lenses in the 1 to 100 rating scale (P>0.05). Narafilcon A showed more moderate to severe dryness symptoms and symptoms of blurred vision at lens wearing visits (P<0.05). One bilateral contact lens papillary conjunctivitis, one unilateral superior epithelial arcuate lesion, and one infiltrative keratitis were associated with narafilcon A only. Of the seven discontinuations, six were from the narafilcon A group. CONCLUSION: Different contact lens materials and designs, worn on the same DD modality, elicit different ocular and patient responses. Narafilcon A did not perform clinically as well as etafilcon A and senofilcon A worn on a DD modality.

Comparison of ocular comfort, vision, and SICS during silicone hydrogel contact lens daily wear.

OBJECTIVES: The aim of this study was to investigate the relationship between solution-induced corneal staining (SICS) and silicone hydrogel contact lens comfort and vision. METHODS: A retrospective analysis of a series of open-label studies were conducted with 24 groups of approximately 40 participants, each wearing 1 of 6 silicone hydrogel contact lenses with 1 of 4 lens care products bilaterally for 3 months of daily wear. The presence of SICS and subjective ocular ratings were collected at 2 weeks and at 1 and 3 months. RESULTS: A total of 1,051 participants were enrolled. The participants with SICS rated significantly less favorably than did the participants without SICS for comfort during the day (7.9±1.7 vs. 8.5±1.4, P=0.03), comfort at the end of the day (6.6±2.1 vs. 7.4±1.9, P=0.03), overall dryness (7.4±1.9 vs. 8.0±1.7, P=0.04), dryness at the end of the day (6.7±2.2 vs. 7.5±2.1, P=0.01), feelings of burning and stinging (8.5±2.0 vs. 8.9±1.8, P=0.02), and overall vision (8.2±1.6 vs. 8.7±1.3, P<0.001). CONCLUSIONS: The participants with SICS had lower subjective comfort and vision compared with those who did not experience SICS.

Contact lens deposits, adverse responses, and clinical ocular surface parameters.

PURPOSE: To correlate clinical responses during contact lens wear with the amount of protein or cholesterol extracted from lenses after wear. METHODS: Clinical parameters, including adverse response rates and corneal staining, and symptomatology rating during lens wear were collected from a series of clinical tests comprising four different silicone hydrogel lenses with four different multipurpose solutions. To test for correlates, the amount of total protein or cholesterol extracted from lenses after daily wear were compared statistically to clinical parameters. RESULTS: The amount of protein (p = 0.008) or cholesterol (p = 0.01) extracted from lenses was higher for those subjects who showed solution-induced corneal staining. Amount of protein extracted was correlated (p < 0.01) with conjunctival staining (R = -0.23), lens front surface wetting (r = 0.14), and lens fit tightness (R = -0.20). These clinical parameters accounted for 48% of lens protein deposition. The amount of cholesterol extracted from lenses was much more weakly associated with clinical variables. Amount of protein or cholesterol extracted from lenses was not associated with the production of any corneal infiltrative or mechanical adverse event during wear and was only very weakly correlated with insertion comfort of lenses. CONCLUSIONS: These results suggest that there may be no physiologically relevant consequence of cholesterol depositing on silicone hydrogel lenses. The amount of protein that deposits onto silicone hydrogel lenses during wear may have more affect on lens performance on-eye. However, the correlations were generally small and may still not indicate any causative relevant physiological response. Further work is required to determine whether there is any direct causative effect to support these correlative findings.

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.

Prompt diagnosis and treatment of microbial keratitis in a daily wear lens.

PURPOSE: Microbial keratitis (MK) is a serious sight-threatening complication occurring with and without contact lens wear. The task of diagnosing MK is difficult because each presentation of the disease is different and can be mistaken for noninfectious ulcers such as contact lens peripheral ulcer (CLPU). The purpose of this article is to present a case report of MK initially diagnosed as a CLPU. CASE REPORT: We report the incidence of a 21-year-old female presenting with signs and symptoms in her left eye, which initially suggested a CLPU. At the 24-h follow-up, contrary to expected indications of healing, her condition had deteriorated. The diagnosis was reevaluated as an MK. Ciloxan was prescribed under care of an ophthalmologist. Despite initial misdiagnosis, due to aggressive topical treatment and the peripheral location of the lesion, <1 line of vision was lost. DISCUSSION: Defined signs and symptoms criteria have been established for the differential diagnoses of MK and CLPU. However, there is often an overlap in the signs and symptoms that can complicate the diagnosis. A critical sign, however, is progress immediately after lens wear is discontinued. Prophylaxis and rapid appropriate treatment and follow-up are vitally important if there is any doubt and to ensure correct diagnosis and resolution. CONCLUSION: Any diagnosis of CLPU must be monitored carefully to ensure it is not MK. Prompt diagnosis and treatment of MK are essential for a good visual outcome.