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.

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.

Visual performance of myopia control soft contact lenses in non-presbyopic myopes.

PURPOSE: To compare the visual performance of soft contact lenses reported to reduce myopia progression. METHODS: In a double-blind, randomized, crossover trial, 30 non-presbyopic myopes wore MiSight™, center-distance Proclear® Multifocal (+2.00 D add), and two prototype lenses for 1 week each. High- and low-contrast visual acuities at 6 m, and 70 and 40 cm; stereopsis at 40 cm; accommodative facility at 33 cm; and horizontal phoria at 3 m and 33 cm were measured after 1 week. Subjective performance was assessed on a numeric rating scale for vision clarity, lack of ghosting, vision stability, haloes, overall vision satisfaction, and ocular comfort. Frequency of eye-strain symptoms and willingness to purchase lenses were also reported with categorical responses. Participants reported wearing times (total and visually acceptable). Linear mixed models and chi-square tests were employed in analysis with level of significance set at 5%. Theoretical optical performance of all lenses was assessed with schematic myopic model eyes (-1.00, -3.00, and -6.00 D) by comparing the slope of the edge spread function (ESF), an indicator for optical performance/resolution and the blur patch size of the line spread function, an indicator for contrast, between the lenses. RESULTS: Proclear Multifocal and MiSight provided the best distance acuities. However, the prototype lenses were rated significantly higher for many subjective variables, and there were no subjective variables where commercial lenses were rated significantly higher than the prototypes. Theoretical optical performance showed steeper slopes of the ESF and greater blur patch sizes of the LSP with commercial lenses, supporting the clinical findings of better visual acuities but reduced subjective performance. Participants wore prototypes longer and reported their vision acceptable for longer each day compared to MiSight. Both prototypes had the highest willingness-to-purchase rate. CONCLUSIONS: The prototypes were better tolerated by myopes compared to the commercial soft contact lenses currently used for slowing myopia progression.

Effects of relative negative spherical aberration in single vision contact lens visual performance.

OBJECTIVE: The study aimed to compare the visual performance of contact lenses with and without negative spherical aberration (SA) over 5 days of wear. METHODS: At baseline, 32 myopic participants (aged 18-33 years) were fitted in a randomized order with two lenses (test lens with minimal or no SA and 1-Day Acuvue Moist designed with negative SA) for 5 days (minimum 6 hours wear/day). Participants returned for a follow-up visit. This consisted of on-axis SA measurements; high- and low-contrast visual acuities at 6 m; high-contrast acuities at 70 and 40 cm; low-illumination, low-contrast acuity at 6 m; stereopsis at 40 cm; horizontal phorias at 3 m and 33 cm; and ±2.00 D monocular accommodative facility at 33 cm. Participants also rated (1-10 scale) vision quality (clarity and lack of ghosting for distance, intermediate, near, driving vision and vision stability during day- and night-time), overall vision satisfaction, ocular comfort, and willingness to purchase (yes/no response). RESULTS: 1-Day Acuvue Moist induced significantly (p<0.05) more negative SA at distance (Δ=0.078 µm) and near (Δ=0.064 µm) compared to the test lens, for a 6 mm pupil. There were no significant differences (p>0.05) in acuity, binocular vision, and all subjective metrics except vision stability between lenses where the test lens was rated to provide more stable vision (p<0.05). CONCLUSION: Contrary to expectations, incorporating negative SA in single vision soft contact lenses did not improve visual performance in non-presbyopic adult myopes.

Extended depth of focus contact lenses vs. two commercial multifocals: Part 2. Visual performance after 1 week of lens wear / Lentes de contacto de profundidad de foco extendido vs. dos lentes multifocales comerciales: Parte 2. Rendimiento visual tras una semana de uso

Purpose: To compare the visual performance of prototype contact lenses designed via deliberate manipulation of higher-order spherical aberrations to extend-depth-of-focus with two commercial multifocals, after 1 week of lens wear. Methods: In a prospective, participant-masked, cross-over, randomized, 1-week dispensing clinical-trial, 43 presbyopes [age: 42-63 years] each wore AIROPTIX Aqua multifocal (AOMF), ACUVUE OASYS for presbyopia (AOP) and extended-depth-of-focus prototypes (EDOF) appropriate to their add requirements. Measurements comprised high-contrast-visual-acuity (HCVA) at 6 m, 70 cm, 50 cm and 40 cm; low-contrast-visual-acuity (LCVA) and contrast-sensitivity (CS) at 6 m and stereopsis at 40 cm. A self-administered questionnaire on a numeric-rating-scale (1-10) assessed subjective visual performance comprising clarity-of-vision and lack-of-ghosting at various distances during day/night-viewing conditions and overall-vision-satisfaction. Results: EDOF was significantly better than AOMF and AOP for HCVA averaged across distances (p ≤ 0.038); significantly worse than AOMF for LCVA (p = 0.021) and significantly worse than AOMF for CS in medium and high add-groups (p = 0.006). None of these differences were clinically significant (≤2 letters). EDOF was significantly better than AOMF and AOP for mean stereoacuity (36 and 13 seconds-of-arc, respectively: p ≤ 0.05). For clarity-of-vision, EDOF was significantly better than AOP at all distances and AOMF at intermediate and near (p ≤ 0.028). For lackof-ghosting averaged across distances, EDOF was significantly better than AOP (p < 0.001) but not AOMF (p = 0.186). EDOF was significantly better than AOMF and AOP for overall-vision satisfaction (p ≤ 0.024). Conclusions: EDOF provides better intermediate and near vision performance than either AOMF or AOP with no difference for distance vision after 1 week of lens wear (AU)

Objetivo: Comparar el rendimiento visual de un prototipo de lentes de contacto diseñadas mediante manipulación deliberada de aberraciones esféricas de alto orden, para ampliar la profundidad de campo con dos lentes multifocales comerciales, tras una semana de uso. Métodos: En un ensayo clínico prospectivo, ciego para los participantes, transversal, aleatorizado, con uso de lentes durante una semana, 43 présbitas [Edad: 42-63 años] utilizaron lentes AIROPTIX Aqua multifocal (AOMF), ACUVUE OASYS para presbicia (AOP) y de profundidad de foco extendido (EDOF) adecuados a sus requisitos de adición. Las mediciones incluyeron agudeza visual de alto contraste (HCVA) a 6 m, 70 cm, 50 cm y 40 cm, agudeza visual de bajo contraste (LCVA), sensibilidad de contraste (CS) a 6 m, y estereopsis a 40 cm. Un cuestionario auto-administrado sobre una escala de evaluación numérica (1-10) valoró el rendimiento visual subjetivo incluyendo la nitidez de visión y la ausencia de imágenes fantasma a diversas distancias en condiciones de visión diurna/nocturna, así como la satisfacción sobre la visión general. Resultados: EDOF fue considerablemente mejor que AOMF y AOP para la media de las distancias HCVA (p ≤ 0,038); considerablemente peor que AOMF para LCVA (p = 0,021) y considerablemente peor que AOMF para CS en los grupos de adición media y elevada (p = 0,006). Ninguna de estas diferencias fueron clínicamente significativas (≤ 2 letras). EDOF fue considerablemente mejor que AOMF y AOP para la estereoagudeza media (36 y 13 segundos de arco, respectivamente: p ≤ 0,05). Para la claridad de visión, EDOF fue considerablemente mejor que AOP en todas las distancias, y AOMF para las distancias intermedia y cercana (p ≤ 0,028). Para la falta de imágenes fantasma promediada a las diferentes distancias, EDOF fue considerablemente mejor que AOP (p < 0,001) pero no así AOMF (p = 0,186). EDOF fue considerablemente mejor que AOMF y AOP en cuanto a satisfacción sobre la visión general (p ≤ 0,024). Conclusiones: EDOF aporta un mejor desempeño de visión intermedia y cercana que AOMF o AOP, sin diferencia de visión lejana tras una semana de uso de lentes de contacto multifocales (AU)

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.

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 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.

Extended depth of focus contact lenses vs. two commercial multifocals: Part 2. Visual performance after 1 week of lens wear.

PURPOSE: To compare the visual performance of prototype contact lenses designed via deliberate manipulation of higher-order spherical aberrations to extend-depth-of-focus with two commercial multifocals, after 1 week of lens wear. METHODS: In a prospective, participant-masked, cross-over, randomized, 1-week dispensing clinical-trial, 43 presbyopes [age: 42-63 years] each wore AIROPTIX Aqua multifocal (AOMF), ACUVUE OASYS for presbyopia (AOP) and extended-depth-of-focus prototypes (EDOF) appropriate to their add requirements. Measurements comprised high-contrast-visual-acuity (HCVA) at 6m, 70cm, 50cm and 40cm; low-contrast-visual-acuity (LCVA) and contrast-sensitivity (CS) at 6m and stereopsis at 40cm. A self-administered questionnaire on a numeric-rating-scale (1-10) assessed subjective visual performance comprising clarity-of-vision and lack-of-ghosting at various distances during day/night-viewing conditions and overall-vision-satisfaction. RESULTS: EDOF was significantly better than AOMF and AOP for HCVA averaged across distances (p≤0.038); significantly worse than AOMF for LCVA (p=0.021) and significantly worse than AOMF for CS in medium and high add-groups (p=0.006). None of these differences were clinically significant (≤2 letters). EDOF was significantly better than AOMF and AOP for mean stereoacuity (36 and 13 seconds-of-arc, respectively: p≤0.05). For clarity-of-vision, EDOF was significantly better than AOP at all distances and AOMF at intermediate and near (p≤0.028). For lack-of-ghosting averaged across distances, EDOF was significantly better than AOP (p<0.001) but not AOMF (p=0.186). EDOF was significantly better than AOMF and AOP for overall-vision-satisfaction (p≤0.024). CONCLUSIONS: EDOF provides better intermediate and near vision performance than either AOMF or AOP with no difference for distance vision after 1 week of lens wear.

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.

Discrimination of subjective responses between contact lenses with a novel questionnaire.

PURPOSE: To describe a ranked symptoms scale (RSS) discriminating subjective responses in contact lens (CL) wear in various situations. METHOD: Forty experienced clinical trial participants were interviewed for their perceptions of ocular comfort scales, resulting in a numerical RSS. For further evaluation, 20 CL wearers enrolled into a prospective, randomised, crossover trial. Two silicone-hydrogel CLs and a lens care solution (LCS) [Combinations A & B] were selected based on prior performance identifying best/worst combinations for end-of-day comfort. The RSS and a numerical rating scale (NRS) were administered at two time-points (insertion/removal) on alternating days for 6 days. RESULTS: Both NRS and RSS showed acceptable internal consistency for comfort, vision and handling (Cronbach alpha=0.71 for both scales) and similar repeatability for comfort and handling (coefficients-of-repeatability within 0.1 and 0.2 units, respectively, for each scale). The NRS and RSS discriminated differences between combinations for comfort (p≤0.031) and vision (p≤0.026) at both time-points. Additionally, the RSS showed lens/edge awareness influenced discomfort the most, ranking higher at insertion (p=0.038) and higher for Combination-B at both time-points (p≤0.002). Symptoms of dryness and tired eyes increased for both combinations at removal (p<0.02). The RSS also showed haziness and blurred distance vision influenced vision dissatisfaction with Combination-B at lens removal (p≤0.038) while eye strain/headache increased for both combinations by time of removal (p≤0.013). CONCLUSIONS: The RSS is able to discriminate subjective responses between combinations and time-of-day. The RSS's ability to rank symptoms may be a useful tool in understanding perceptions of discomfort or dissatisfaction with CL wear.

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.

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.