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.

CLEAR - Contact lens optics.

The most fundamental aspect of a contact lens is its optics; the manner in which the refraction of light is managed to optimise vision to the clinical benefit of the lens wearer. This report presents contemporary information on the optical structure of the eye and the optical models employed to understand the correction of refractive error. The design, measurement and clinical assessment of spherical, aspheric, toric, multifocal and myopia control contact lenses are described. The complexity and variety of multifocal lenses is recognised and detailed information is provided for alternating, simultaneous, diffractive, annular, aspheric and extended depth of field lens designs. In terms of clinical assessment, a contemporary review is provided for the measurement of: visual acuity, contrast sensitivity, through focus curves, reading performance, peripheral refraction, toric displacement realignment and patient reported outcomes. Overall, the paper aims to serve as a resource for the prescribing clinician, who can optimise contact lens corrections for patients by building on the optical rationale of these devices; and also highlights future opportunities for research innovation.

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.

Peripheral refraction and spherical aberration profiles with single vision, bifocal and multifocal soft contact lenses / Perfiles de refracción periférica y aberración esférica con lentes de contacto blandas de monofocales, bifocales y multifocales

PURPOSE: To compare the peripheral refraction and spherical aberration profiles along three visual field meridians of 16 commercial single vision (SV), bifocal (BF) and multifocal (MF) test contact lenses with a single vision control. METHOD: Forty-four participants [24.2 ± 2.4 years, SE: -0.50 to -4.50D] were randomly fitted, contra-laterally, with 6 SV's [Air Optix Aqua (control), Acuvue Oasys, Biofinity, Clariti, Night & Day and Proclear], 3 BF's [Acuvue Bifocal low and high add, MiSight] and 8 MF's [Proclear D & N in 1.5 and 2.5D adds; AirOptix, PureVision low & high adds]. Peripheral refraction was performed across horizontal, oblique and vertical meridians, with lenses on eye using the BHVI-EyeMapper. The power vectors M, J0, J45 and the spherical aberration coefficient were analysed. The peripheral refraction and aberration profiles of the test lenses were compared with the profiles of the control lens using curvature and slope coefficients. RESULTS: Compared to the control, a relative peripheral hyperopic shift (M), a less negative J0 curvature coefficient along the horizontal meridian, a less positive J0 curvature coefficient along the vertical meridian, a less negative J45 curvature coefficient along the oblique meridian and a more positive spherical aberration curvature coefficient along most meridians was seen with the Acuvue Bifocal and all center-near multifocal lenses. For the center-distance multifocal lenses the direction of the curvature coefficients of the same refraction and aberration components was opposite to that of the center-near lenses. The greatest differences in the slope coefficients when compared to the control were found for the Acuvue Bifocal lenses and all multifocal contact lenses for the refractive component M and the spherical aberration coefficient along the horizontal visual field meridian, with the Acuvue Bifocal and the center-near multifocal lenses having more positive coefficients and the center-distance lenses having more negative coefficients. CONCLUSION: When worn on eye, different commercially available lens types produce differences in the direction and magnitude of the peripheral refraction and spherical aberration profiles along different visual field meridians. This information may be relevant to refractive development and myopia control

OBJETIVO: Comparar los perfiles de refracción periférica y aberración esférica en tres meridianos del campo visual de 16 lentes de contacto (LC) comerciales de prueba monofocales (VS), bifocales (BF) y multifocales (MF), con control de visión simple. MÉTODO: Colocamos aleatoria y contralateralmente a cuarenta participantes [44,2 ± 2,4 años, SE: -0,5 a -4,5 D]: 6 LC monofocales [Air Optix Aqua (control), Acuvue Oasys, Biofinity, Clariti, Night & Day y Proclear], 3 bifocales [Acuvue Bifocal con adición baja y alta, MiSight] y 8 MF [Proclear D & N con adición de 1,5 y 2,5D; AirOptix, PureVision con adición baja y alta]. Realizamos la refracción periférica en los meridianos horizontal, oblicuo y vertical, con lentillas en un ojo utilizando el BHVI-EyeMapper. Se analizaron los vectores de potencia M, J0, J45 y el coeficiente de aberración esférica. Se compararon los perfiles de refracción periférica y aberración esférica de las LC de prueba con los perfiles de las LC de control utilizando los coeficientes de curvatura y pendiente. RESULTADOS: En comparación con el control, observamos un cambio hiperópico periférico relativo (M), un coeficiente de curvatura J0 menos negativo en el meridiano horizontal, un coeficiente de curvatura J0 menos positivo en el meridiano vertical, un coeficiente de curvatura J45 menos negativo en el meridiano oblicuo, y un coeficiente de curvatura de aberración esférica más positivo en la mayoría de meridianos con las lentillas Acuvue Bifocal y todas las lentillas multifocales de diseño centro-cerca. Para las lentillas multifocales centro-lejos la dirección de los coeficientes de curvatura de los mismos componentes de refracción y aberración fue opuesta a la de las lentillas centro-cerca. Las mayores diferencias en cuanto a coeficientes de pendiente, al compararse con el control, se encontraron en las lentillas Acuvue Bifocal y en todas las lentillas multifocales para el componente refractivo M y el coeficiente de aberración esférica en el meridiano del campo visual horizontal, siendo las lentillas Acuvue Bifocal y las multifocales centro-cerca las que mostraron más coeficientes positivos, y las lentillas centro-lejos las que reflejaron más coeficientes negativos. CONCLUSIÓN: Al colocarse en un solo ojo, las diferentes lentillas comerciales producen diferencias en cuanto a dirección y magnitud de los perfiles de refracción periférica y aberración esférica en los diferentes meridianos del campo visual. Esta información puede ser relevante para el desarrollo refractivo y el control de la miopía

Peripheral refraction and spherical aberration profiles with single vision, bifocal and multifocal soft contact lenses.

PURPOSE: To compare the peripheral refraction and spherical aberration profiles along three visual field meridians of 16 commercial single vision (SV), bifocal (BF) and multifocal (MF) test contact lenses with a single vision control. METHOD: Forty-four participants [24.2±2.4 years, SE: -0.50 to -4.50D] were randomly fitted, contra-laterally, with 6 SV's [Air Optix Aqua (control), Acuvue Oasys, Biofinity, Clariti, Night & Day and Proclear], 3 BF's [Acuvue Bifocal low and high add, MiSight] and 8 MF's [Proclear D & N in 1.5 and 2.5D adds; AirOptix, PureVision low & high adds]. Peripheral refraction was performed across horizontal, oblique and vertical meridians, with lenses on eye using the BHVI-EyeMapper. The power vectors M, J0, J45 and the spherical aberration coefficient were analysed. The peripheral refraction and aberration profiles of the test lenses were compared with the profiles of the control lens using curvature and slope coefficients. RESULTS: Compared to the control, a relative peripheral hyperopic shift (M), a less negative J0 curvature coefficient along the horizontal meridian, a less positive J0 curvature coefficient along the vertical meridian, a less negative J45 curvature coefficient along the oblique meridian and a more positive spherical aberration curvature coefficient along most meridians was seen with the Acuvue Bifocal and all center-near multifocal lenses. For the center-distance multifocal lenses the direction of the curvature coefficients of the same refraction and aberration components was opposite to that of the center-near lenses. The greatest differences in the slope coefficients when compared to the control were found for the Acuvue Bifocal lenses and all multifocal contact lenses for the refractive component M and the spherical aberration coefficient along the horizontal visual field meridian, with the Acuvue Bifocal and the center-near multifocal lenses having more positive coefficients and the center-distance lenses having more negative coefficients. CONCLUSION: When worn on eye, different commercially available lens types produce differences in the direction and magnitude of the peripheral refraction and spherical aberration profiles along different visual field meridians. This information may be relevant to refractive development and myopia control.

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.

Extended depth of focus contact lenses vs. two commercial multifocals: Part 1. Optical performance evaluation via computed through-focus retinal image quality metrics / Lentes de contacto de profundidad de foco extendido vs. dos lentes multifocales comerciales: Parte 1. Evaluación del rendimiento óptico del enfoque computarizado mediante métricas de calidad de imagen retinianas

Purpose: To compare the computed optical performance of prototype lenses designed using deliberate manipulation of higher-order spherical aberrations to extend depth-of-focus (EDOF) with two commercial multifocals. Methods: Emmetropic, presbyopic, schematic eyes were coupled with prototype EDOF and commercial multifocal lenses (Acuvue Oasys for presbyopia, AOP, Johnson & Johnson & Air Optix Aqua multifocal, AOMF, Alcon). For each test configuration, the through-focus retinal image quality (TFRIQ) values were computed over 21 vergences, ranging from -0.50 to 2.00 D, in 0.125 D steps. Analysis was performed considering eyes with three different inherent aberration profiles: five different pupils and five different lens decentration levels. Results: Except the LOW design, the AOP lenses offered ‘bifocal’ like TFRIQ performance. Lens performance was relatively independent to pupil and aberrations but not centration. Contrastingly, AOMF demonstrated distance centric performance, most dominant in LOW followed by MED and HIGH designs. AOMF lenses were the most sensitive to pupil, aberrations and centration. The prototypes demonstrated a ‘lift-off’ in the TFRIQ performance, particularly at intermediate and near, without trading performance at distance. When compared with AOP and AOMF, EDOF lenses demonstrated reduced sensitivity to pupil, aberrations and centration. Conclusion: With the through focus retinal image quality as the gauge of optical performance, we demonstrated that the prototype EDOF designs were less susceptible to variations in pupil, inherent ocular aberrations and decentration, compared to the commercial designs. To ascertain whether these incremental improvements translate to a clinically palpable outcome requires investigation through human trials (AU)

Objetivo: Comparar el rendimiento óptico computado de los prototipos de lentes de contacto diseñadas mediante manipulación deliberada de aberraciones esféricas de alto orden para conseguir la profundidad de foco extendida (EDOF) con dos lentes multifocales comerciales. Métodos: Se adaptaron lentes de contacto con prototipo EDOF, y lentes multifocales comerciales a ojos esquemáticos présbitas emétropes (Acuvue Oasys para presbicia, AOP, Johnson & Johnson & Air Optix Aqua multifocal, AOMF, Alcon). Para cada configuración de la prueba se obtuvieron los valores de la calidad de imagen de la retina a través del foco (TFRIQ) en 21 vergencias, que oscilaron entre -0,5 y 2D, en pasos de 0,125D. Se llevó a cabo el análisis considerando los ojos con tres perfiles de aberración diferentes: cinco pupilas diferentes y cinco niveles de descentramiento de lentes distintos. Resultados: Exceptuando el diseño LOW, las lentes AOP aportaron un rendimiento TFRIQ de tipo ‘bifocal’. El desempeño de las lentes fue relativamente independiente de la pupila y aberraciones, pero no del descentramiento. Por contra, AOMF demostró un rendimiento céntrico en visión lejana, más dominante en el diseño LOW, seguido de los diseños MED y HIGH. Las lentes AOMF fueron más sensibles a la pupila, aberraciones y centrado. Los prototipos demostraron un efecto de mejora en el rendimiento TFRIQ, particularmente en visión intermedia y próxima, sin pérdida de rendimiento en visión lejana. Al compararlas con las lentes AOP y AOMF, las lentes EDOF demostraron una reducción de la sensibilidad al factor pupila, las aberraciones y el centrado. Conclusión: Con la calidad de imagen de la retina a través del foco, como medida del rendimiento óptico, demostramos que los diseños del prototipo EDOF fueron menos susceptibles a las variaciones de la pupila, las aberraciones oculares inherentes, y al descentramiento, en comparación a los diseños comerciales. Se precisa más investigación futura, mediante ensayos en humanos, para verificar si estas mejoras incrementales se trasladan a resultados clínicamente evaluables (AU)

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)

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 1. Optical performance evaluation via computed through-focus retinal image quality metrics.

PURPOSE: To compare the computed optical performance of prototype lenses designed using deliberate manipulation of higher-order spherical aberrations to extend depth-of-focus (EDOF) with two commercial multifocals. METHODS: Emmetropic, presbyopic, schematic eyes were coupled with prototype EDOF and commercial multifocal lenses (Acuvue Oasys for presbyopia, AOP, Johnson & Johnson & Air Optix Aqua multifocal, AOMF, Alcon). For each test configuration, the through-focus retinal image quality (TFRIQ) values were computed over 21 vergences, ranging from -0.50 to 2.00D, in 0.125D steps. Analysis was performed considering eyes with three different inherent aberration profiles: five different pupils and five different lens decentration levels. RESULTS: Except the LOW design, the AOP lenses offered 'bifocal' like TFRIQ performance. Lens performance was relatively independent to pupil and aberrations but not centration. Contrastingly, AOMF demonstrated distance centric performance, most dominant in LOW followed by MED and HIGH designs. AOMF lenses were the most sensitive to pupil, aberrations and centration. The prototypes demonstrated a 'lift-off' in the TFRIQ performance, particularly at intermediate and near, without trading performance at distance. When compared with AOP and AOMF, EDOF lenses demonstrated reduced sensitivity to pupil, aberrations and centration. CONCLUSION: With the through focus retinal image quality as the gauge of optical performance, we demonstrated that the prototype EDOF designs were less susceptible to variations in pupil, inherent ocular aberrations and decentration, compared to the commercial designs. To ascertain whether these incremental improvements translate to a clinically palpable outcome requires investigation through human trials.

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.

Peripheral Refraction and Aberration Profiles with Multifocal Lenses.

SIGNIFICANCE: The amount of central or peripheral myopic shift, as induced by different multifocal contact lenses when viewing objects at distance or near, may provide insights on the potential efficacy for slowing eye growth. PURPOSE: The present study aims to compare peripheral refraction and higher-order aberration profiles of four multifocal contact lenses with a single vision control lens. METHODS: Thirty-five myopes (age 21.2 ± 2.1 years) completed the trial, of whom 16 wore Air Optix Aqua and Proclear Multifocal Distance and Near (Group 1, spherical equivalent: -2.90 ± 0.95D), whereas 19 wore Air Optix Aqua, Air Optix Multifocal, and PureVision Multifocal (Group 2, spherical equivalent: -2.95 ± 0.78D). Refraction and aberration profiles with lenses were measured using the BHVI-EyeMapper with (-2.00 to -5.00D in 1.00D steps) and without (+1.00D fogging) accommodation. Data were quantified using M2/4 (2nd and 2nd + 4th order), J0, J45, and higher-order aberration coefficients coma C[3, 1] and spherical aberration C[4, 0]. RESULTS: The center-distance lens exhibited a relative peripheral myopic shift in M2/4 and J0, positive on-axis C[4, 0], negative on-axis C[3, 1] and on-axis M4 was less negative for accommodative demands ≤-3.00D (P < .05). Inversely, the center-near lenses showed a relative peripheral hyperopic shift in M2/4 and J0, negative on-axis C[4, 0], positive on-axis C[3, 1] and on-axis M4 was more negative for demands of -2.00 and -3.00D (P < .05). Independent of lens type, relative peripheral M4 significantly decreased during accommodation. Accounting for C[4, 0], a greater change in relative M profiles and accommodative responses was found for multifocal lenses. CONCLUSIONS: Based on the hypothesis that myopic retinal defocus counters eye growth, center-near multifocal lenses exhibited the preferred on-axis features, i.e., producing a central myopic shift at near compared to the control. The center-distance lens exhibited preferred off-axis features, producing relative peripheral myopia, which increased further during accommodation.

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.