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.

Comparing children's, teenagers' and young adults' subjective responses to myopia control contact lenses.

INTRODUCTION: Myopia control (MC) studies in children link efficacy with subjective performance. There is little MC research in teenagers and young adults. This study compared subjective experience of MC contact lenses in different age groups. METHODS: Data were retrospectively reviewed from two double-masked, bilateral wear, crossover contact lens clinical trials (myopia -0.75D to -3.50D and <1.00 DC; 9-35 years). Participants wore two novel lenses (MC lenses with relative peripheral plus [+1.50D and +2.50D]) and a single-vision (SV) control lens (Clariti® 1 day) for 1 week each. All lenses were made from Somofilcon A material. Data collected included visual acuity (VA), wearing time, subjective ratings of comfort, distance and near vision clarity and overall vision. Generalised estimating equations with subject random intercepts and identity link functions were used in the analysis. RESULTS: A total of 31 participants (10 children, 11 teenagers and 10 adults) were included, with no difference between the age groups for VA with the dispensed lenses (p > 0.05). All groups could discriminate between the SV and MC lenses for vision (distance, near and overall) after 1 week (p < 0.05). There was no difference between groups for comfort or distance and near vision. Children rated the overall vision quality higher than teenagers and adults for both SV and MC lenses (p < 0.05), but there was no difference relative to the SV lens between groups (p > 0.50). Daily wear time was lowest for children for all lens types (all p < 0.02). Wear time was positively associated with ratings of overall vision quality for children and young adults (both p < 0.05). CONCLUSION: All age groups rated SV lenses higher than MC lenses. Subjective ratings of MC lenses appear similar between age groups relative to SV lenses. Wear time was lowest in children and was correlated with overall vision quality ratings in children and young adults.

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.

Associations between Binocular Vision Disorders and Contact Lens Dissatisfaction.

SIGNIFICANCE: These data demonstrate that binocular vision disorders (BVDs) contribute to contact lens (CL) dissatisfaction independently of CL discomfort (CLD) in myopic, pre-presbyopic, adult, single-vision CL wearers. PURPOSE: This study aimed to determine whether BVDs contribute to CL dissatisfaction and whether this contribution is independent of CLD. METHODS: Participants attended one clinical visit while wearing their habitual CLs. Symptoms from CLD and BVDs were measured with the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and Convergence Insufficiency Syndrome Survey (CISS), respectively. A comprehensive binocular vision (BV) assessment was performed. The Ocular Surface Disease Index (OSDI) was used to measure CL dissatisfaction from CLD and BVDs based on reported correlations between the CLDEQ-8 and the CISS with the OSDI. Participants were categorized according to their CL comfort status (CLD [≥12 on CLDEQ-8] or non-CLD [<12 on CLDEQ-8]) and BV status (BVD or non-BVD). RESULTS: Seventy-six participants completed the trial, and 19 (25%) were diagnosed with BVD. Those diagnosed with BVD scored higher than did those diagnosed with non-BVD for the OSDI (25.1 ± 12.7 vs. 10.7 ± 7.3, P < .001) and CISS (18.7 ± 7.7 vs. 11.9 ± 5.9, P = .001), but not the CLDEQ-8 (P = .25). Those categorized as having CLD scored higher than did those categorized as having non-CLD for the OSDI (19.0 ± 12.3 vs. 9.3 ± 5.9, P = .003) and CISS (16.1 ± 6.8 vs. 11.0 ± 6.2, P = .001). There were no significant interactions between BV status and CL comfort status for any questionnaire (P > .08). CONCLUSIONS: Higher scores for OSDI in those with CLD or BVD indicate that both conditions contribute to CL dissatisfaction. Higher scores for the CISS in those with CLD suggest a degree of overlap for some BVD symptoms. Nonsignificant differences between BVD and non-BVD for the CLDEQ-8 suggest that BVDs contribute to CL dissatisfaction independently of CLD.

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.

Myopia control with novel central and peripheral plus contact lenses and extended depth of focus contact lenses: 2 year results from a randomised clinical trial.

PURPOSE: We aimed to determine myopia control efficacy with novel contact lenses (CL) that (1) reduced both central and peripheral defocus, and (2) provided extended depth of focus with better global retinal image quality for points on, and anterior to, the retina and degraded for points posterior to the retina. METHODS: Children (n = 508, 8-13 years) with cycloplegic spherical equivalent (SE) -0.75 to -3.50D were enrolled in a prospective, double blind trial and randomised to one of five groups: (1) single vision, silicone hydrogel (SH) CL; (2) two groups wearing SH CL that imposed myopic defocus across peripheral and central retina (test CL I and II; +1.00D centrally and +2.50 and +1.50 for CL I and II at 3 mm semi-chord respectively); and (3) two groups wearing extended depth of focus (EDOF) hydrogel CL incorporating higher order aberrations to modulate retinal image quality (test CL III and IV; extended depth of focus of up to +1.75D and +2.50D respectively). Cycloplegic autorefraction and axial length (AL) measurements were conducted at six monthly intervals. Compliance to lens wear was assessed with a diary and collected at each visit. Additionally, subjective responses to various aspects of lens wear were assessed. The trial commenced in February 2014 and was terminated in January 2017 due to site closure. Myopia progression over time between groups was compared using linear mixed models and where needed post hoc analysis with Bonferroni corrections conducted. RESULTS: Myopia progressed with control CL -1.12 ± 0.51D/0.58 ± 0.27 mm for SE/AL at 24 months. In comparison, all test CL had reduced progression with SE/AL ranging from -0.78D to -0.87D/0.41-0.46 mm at 24 months (AL: p < 0.05 for all test CL; SE p < 0.05 for test CL III and IV) and represented a reduction in axial length elongation of about 22% to 32% and reduction in spherical equivalent of 24% to 32%. With test CL, a greater slowing ranging from 26% to 43% was observed in compliant wearers (≥6 days per week; Control CL: -0.64D/0.30 mm and -1.14D/0.58 mm vs test CL: -0.42D to -0.47D/0.12-0.18 mm and -0.70 to -0.81D/0.19-0.25 mm at 12 and 24 months respectively). CONCLUSIONS: Contact lenses that either imposed myopic defocus at the retina or modulated retinal image quality resulted in a slower progression of myopia with greater efficacy seen in compliant wearers. Importantly, there was no difference in the myopia control provided by either of these strategies.

Vision Performance and Accommodative/Binocular Function in Children Wearing Prototype Extended Depth-of-Focus Contact Lenses.

OBJECTIVE: To assess two prototype contact lenses (CLs) that extend depth of focus through deliberate manipulation of multiple spherical aberration terms (extended depth-of-focus [EDOF]) for visual performance, accommodative and binocular function, and objective static near refraction against a single-vision (SV) CL. METHOD: This was a prospective, randomized, cross-over, single-masked (participant) clinical trial in which 16 myopic children wore 2 prototype CLs (EDOFL/EDOFH) designed for presbyopes and a SV CL, each for one week. Measurements comprised monocular and binocular high-contrast visual acuity (HCVA: 6 m, 40 cm), binocular low-contrast visual acuity (LCVA: 6 m), contrast sensitivity (CS: 6 m), phorias (3 m, 33 cm), monocular-accommodative facility (33 cm), and objective static refraction (spherical equivalent M) at zero, -3, and -5 D vergences. Measurements were taken 10 min after lens insertion. Subjective response was assessed using take-home questionnaires comprising vision clarity (distance/intermediate/near), vision quality (haloes at night/ghosting), vision stability when moving (playing sport/using stairs), and comfort. RESULTS: Single vision was significantly better than both EDOF CLs for monocular HCVA, LCVA, and CS (6 m); vision clarity (distance), ghosting (P≤0.040), and EDOFL for binocular HCVA (6 m, P=0.047). M was significantly closer to the ideal objective static refraction at -3 and -5 D vergences (P≤0.004) with both EDOF compared with SV CLs. There were no differences between CLs for any other variable (P≥0.169). CONCLUSION: Extended depth-of-focus CLs caused minimal disruption to the accommodative and binocular system compared with SV CLs when worn by myopic children. Future EDOF designs for children should reduce the difference between SV for distance vision and vision quality while maintaining the same performance for intermediate and near.

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.

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.

Short-Term Visual Performance of Novel Extended Depth-of-Focus Contact Lenses.

PURPOSE: To compare the objective and subjective visual performance of a novel contact lens which extends depth of focus by deliberate manipulation of higher-order spherical aberrations and a commercially available zonal-refractive multifocal lens. METHODS: A prospective, cross-over, randomized, single-masked, short-term clinical trial comprising 41 presbyopes (age 45 to 70 years) wearing novel Extended Depth of Focus lenses (EDOF) and ACUVUE OAYS for Presbyopia (AOP). Each design was assessed on different days with a minimum overnight wash-out. Objective measures comprised high-contrast visual acuity (HCVA, logMAR) at 6 m, 70 cm, 50 cm, and 40 cm; low-contrast visual acuity (LCVA, logMAR) and contrast sensitivity (log units) at 6 m; and stereopsis (seconds of arc) at 40 cm. HCVA at 70 cm, 50 cm, and 40 cm were measured as "comfortable acuity" rather than conventional resolution acuity. Subjective performance was assessed on a 1-10 numeric rating scale for clarity of vision and ghosting at distance, intermediate and near, overall vision satisfaction, ocular comfort, and lens purchase. Statistical analysis included repeated measures ANOVA and paired t tests. RESULTS: HCVA, clarity of vision, and ghosting with EDOF were significantly better than AOP (p < 0.01); however, differences were dependent on testing distances and add groups. Post hoc analysis showed EDOF was significantly better than AOP for HCVA at 70 cm (0.11 ± 0.11 vs. 0.21 ± 0.16, p < 0.001), 50 cm (0.26 ± 0.17 vs. 0.36 ± 0.18, p = 0.003), 40 cm (0.42 ± 0.17 vs. 0.52 ± 0.21, p = 0.001), and LCVA at 6 m (0.22 ± 0.08 vs. 0.27 ± 0.12, p = 0.024). EDOF was significantly better than AOP for clarity of vision at distance (7.7 ± 1.6 vs. 6.8 ± 2.3, p = 0.029), intermediate (8.8 ± 1.4 vs. 7.0 ± 2.2, p < 0.001), and near (7.4 ± 2.4 vs. 5.2 ± 2.7, p < 0.001), ghosting at distance (9.1 ± 1.2 vs. 8.1 ± 2.5, p = 0.005), and overall vision satisfaction (7.6 ± 1.6 vs. 6.0 ± 2.6, p < 0.001). More participants chose to purchase EDOF compared to AOP (61 vs. 39%) and significantly more chose to only-purchase EDOF compared to only-purchase AOP (27 vs. 5%, p = 0.022). CONCLUSIONS: When compared with AOP, EDOF lenses provide better intermediate and near vision performance in presbyopic participants without compromising distance vision.

Ocular discomfort responses after short periods of contact lens wear.

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

Consequences of wear interruption for discomfort with contact lenses.

PURPOSE: To establish whether increased end-of-day discomfort during soft contact lens wear is associated with short-term changes occurring to the lens itself. METHODS: Twenty-seven subjects wore hydrogel lenses (Focus Dailies; Alcon) bilaterally for 10 hours on two separate days. Comfort was reported using 1-100 numerical rating scales (1 = intolerable discomfort, 100 = lens cannot be felt). Day 1 ratings were taken before lens insertion and at 0.05, 5, and 10 hours post-insertion. Day 2 ratings occurred at similar times, but lenses were removed after the 5-hour assessment and either reinserted (n = 14) or newly replaced (n = 12). An additional rating was taken 5 minutes after re-insertion. Wear then continued to the 10-hour point. In a separate study, 24 different subjects repeated these procedures using a silicone hydrogel lens (AirOptix Aqua; Alcon) with wear taking place on 3 days to permit lens replacement to be with existing as well as new lenses in all subjects. RESULTS: For hydrogel lenses, comfort scores (mean ± 95% CI) reported after 10 hours were 79.4 ± 8.3 when lenses were worn un-replaced, compared with 73.2 ± 9.2 for replacement with the existing lens. When replacement was with a brand new lens, the corresponding values were 72.9 ± 10.9 (un-replaced) versus 69.2 ± 12.8 (new lens replacement). For silicone hydrogel lenses, 10-hour comfort was 90.3 ± 3.2 (un-replaced) versus 92.2 ± 2.9 (replacement with existing lens) versus 90.0 ± 3.3 (replacement with new lens). Differences between replacement conditions were not significant in any case (analysis of variance, p > 0.05). CONCLUSIONS: Final comfort was not influenced by replacing lenses midway through the wearing period. Comfort decrements experienced by users of these daily contact lenses towards the later part of the wearing period are not caused by changes occurring to the lenses on this time scale. Possible alternative etiological factors include a fatigue-like response in one or more ocular tissues or stimulation of ocular surface nociceptors induced by the presence of the contact lens.

The effect of compliance on contact lens case contamination.

PURPOSE: To determine the efficacy of written instructions on contact lens case hygiene and to quantify the effect of noncompliance on contact lens case contamination. METHODS: Data were retrospectively analyzed from 16 prospective, 3-month daily-wear studies during which six commercially available silicone hydrogel contact lenses and seven lens care solutions (LCS) were tested following a similar protocol. Verbal instructions regarding case hygiene (rinse case with LCS, not tap water) were given in nine studies, while the same instructions were given verbally and in written format in seven studies. A survey on contact lens, LCS, and lens case hygiene was completed at 1- and 3-month visits and compliance with case hygiene instructions was determined. Regular contact lens cases were used for 1 month and collected for microbial analysis at the 1- and 3-month visits. The rate of case contamination and the types of microbes contaminating cases were evaluated. RESULTS: Participants given verbal and written instructions were more likely to be compliant with case hygiene instructions than those just given verbal instructions (odds ratio [OR]: 2.19, p < 0.001, 95% confidence interval [CI]: 1.40-3.44). The overall case contamination rate was 79%. Use of tap water to rinse contact lens cases was associated with significantly more cases contaminated with Gram-negative bacteria (GNB) (30% vs. 10%, p < 0.001), a greater risk of GNB case contamination (OR: 2.91, p < 0.001. 95% CI: 1.72-4.92), and a higher quantity of GNB in cases (mean colony-forming unit/case ± SD: 28,286 ± 131,935 vs. 6477 ± 60,447, p < 0.001). CONCLUSIONS: Lens case hygiene can be improved by effective communication of instructions. Contact lens wearers should be actively discouraged from rinsing contact lens cases with tap water because of the increased risk of GNB contamination.

Short-term clinical comparison of two dual-disinfection multipurpose disinfecting solutions.

OBJECTIVE: To compare the short-term clinical performance of two dual-disinfectant multipurpose disinfecting solutions (MPDS) when used in conjunction with two silicone hydrogel contact lenses. METHODS: Participants wore galyfilcon A and balafilcon A lenses, randomly allocated one type to each eye. Multipurpose disinfecting solutions were double-masked and allocated using a randomized crossover design. Lenses were presoaked overnight in the allocated MPDS, containing either polyquaternium-1/alexidine dihydrochloride (PQ-alexidine) or polyquaternium-1/myristamidopropyl dimethylamine (PQ-MAPDA). Lenses were worn daily for 4 days and disinfected with the same MPDS in which they had been soaked. Clinical assessments occurred immediately after insertion, 2 hours after insertion, and after 2 hours of wear on day 4. Subjective ratings were collected at each assessment and after 6 hours of wear on days 1 to 3. Linear mixed models were used for statistical analysis. RESULTS: Solution-induced corneal staining (SICS) incidence was significantly different between MPDS lens combinations (P=0.01) with PQ-MAPDA-balafilcon A showing the highest incidence (27.8%). The incidence of SICS was significantly higher when balafilcon A lenses were worn compared with galyfilcon A (19.4% vs. 2.8%; P=0.04). There was no significant difference in SICS incidence between MPDS (PQ-alexidine=5.6%, PQ-MAPDA=16.7%; P=0.08). Polyquaternium-1/alexidine dihydrochloride was associated with significantly fewer symptoms of burning/stinging (9.7±0.6 vs. 9.1±2.2; P=0.03) and self-assessed redness (9.8±0.5 vs. 9.2±1.9; P=0.03) on initial lens insertion. There were no significant differences between MPDS for comfort ratings (P>0.05). CONCLUSION: These short-term clinical results provide an initial indication that PQ-alexidine is associated with fewer symptoms on insertion but no significant difference in ocular comfort compared with PQ-MAPDA. Longer studies are required to provide further evidence.