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.

Comparison of vision performance of spectacles prescribed to 0.05D versus 0.25D steps.

CLINICAL RELEVANCE: Traditionally, refraction is performed, and spectacles are manufactured in in 0.25D-steps. Trial and spectacle lenses manufactured in smaller increments may allow for a more accurate refraction and prescribed spectacles. BACKGROUND: To determine whether refraction in 0.05D-steps improves the proportion of eyes achieving achieve duochrome equality, and whether spectacles prescribed in 0.05D-steps offer any vision benefits, compared to 0.25D-steps. METHODS: Myopic young adults were enrolled into two prospective studies conducted at different sites. Study 1 comprised 66 participants (refracted under cycloplegia) while Study 2 comprised 51 participants (not cyclopleged). A standard refraction was performed in both studies and a trial frame and trial lenses were used to determine the spherical endpoint of duochrome equality (0.25D-steps first then 0.05D-steps). In Study 2, the cylindrical component was refined in 0.05D-steps before the spherical endpoint in 0.05D-steps. Monocular high-contrast-visual-acuity (HCVA) was measured while wearing the final refractions. Participants in Study 2 wore spectacles manufactured in 0.25D and 0.05D-steps for 7 days each in a randomized, double-masked study. Both spectacles appeared identical. Outcome measures assessed on dispensing and after 7 days of wear comprised monocular acuity-based measurements (HCVA, low-contrast-visual-acuity, vanishing-optotype-acuity, contrast-sensitivity) and subjective ratings. The Quality-of-Vision questionnaire and subjective preference were assessed after 7 days. RESULTS: Both studies showed a higher proportion of eyes achieved duochrome equality (P < 0.001) and better average monocular HCVA (P ≤ 0.006) in 0.05D-steps. Study 2 showed 0.05D-step spectacles provided better average results for all monocular acuity-based measurements (P < 0.006) and were preferred by 65% (P = 0.04) of participants after 7 days (P = 0.04). There were no differences between spectacles for any other measures (P > 0.1). CONCLUSIONS: Refraction performed, and spectacles manufactured in 0.05D-steps for this study improved average acuity-based outcomes and were preferred by most participants to spectacles in traditional 0.25D-steps.

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.

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.

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.

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.

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.

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.

Short-term comparison between extended depth-of-focus prototype contact lenses and a commercially-available center-near multifocal.

PURPOSE: To compare the visual performance of prototype contact lenses which extend depth-of-focus (EDOF) by deliberate manipulation of multiple higher-order spherical aberration terms and a commercially-available center-near lens (AIR OPTIX Aqua Multifocal, AOMF). METHODS: This was a prospective, cross-over, randomized, single-masked (participant), short-term clinical trial where 52 participants (age 45-70 years) were stratified as low, medium or high presbyopes and wore EDOF and AOMF on different days. Objective measures comprised high and low contrast visual acuity (HCVA/LCVA, logMAR), and contrast sensitivity (log units) at 6m; HCVA at 70cm, 50cm and 40cm and stereopsis (seconds of arc) at 40cm. HCVA at 70cm, 50cm and 40cm were measured as "comfortable acuity" rather than conventional resolution acuity. Subjective measures comprised clarity-of-vision and ghosting at distance, intermediate and near, overall vision satisfaction and ocular comfort (1-10 numeric rating scale) and lens purchase (yes/no response). Statistical analysis included repeated measures ANOVA, paired t-tests and McNemar's test. RESULTS: Significant differences between lens types were independent of strata (p≥0.119). EDOF was significantly better than AOMF for HCVA at 40cm (0.42±0.18 vs. 0.48±0.22, p=0.024), stereopsis (98±88 vs. 141±114, p<0.001), clarity-of-vision at intermediate (8.5±1.6 vs. 7.7±1.9, p=0.006) and near (7.3±2.5 vs. 6.2±2.5, p=0.005), lack-of-ghosting (p=0.012), overall vision satisfaction (7.5±1.7 vs. 6.4±2.2, p<0.001) and ocular comfort (9.0±1.0 vs. 8.3±1.7, p=0.002). Significantly more participants chose to only-purchase EDOF (33% vs. 6%, p=0.003).). There were no significant differences between lens types for any objective measure at 6m or clarity-of-vision at distance (p≥0.356). CONCLUSIONS: EDOF provides better intermediate and near vision performance in presbyopes than AOMF with no difference for distance vision during short-term wear.