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)

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.

Short-term comparison between extended depth-of-focus prototype contact lenses and a commercially-available center-near multifocal / Comparación a corto plazo entre las lentes prototipo de profundidad de campo extendidas y las lentes multifocales de visión central-próxima, comercialmente disponibles

Purpose: To compare the visual performance of prototype contact lenses which extend depthof-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), shortterm 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, log MAR), and contrast sensitivity (log units) at 6 m; HCVA at 70 cm, 50 cm and 40 cm 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 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 40 cm (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 6 m 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 (AU)

Objetivo: Comparar el rendimiento visual de prototipos de lentes de contacto con las de profundidad de campo extendida (EDOF), mediante la manipulación deliberada de múltiples aberraciones esféricas de alto orden y las lentes de visión simultánea centro-cerca comercialmente disponibles (AIR OPTIX Aqua Multifocal, AOMF). Métodos: Ensayo clínico prospectivo, transversal, aleatorizado, con máscara única (participante), y a corto plazo, en el que se estratificó la presbicia de 52 participantes (de edades comprendidas entre 45 y 70 años) como baja, media o alta; dichos participantes utilizaron lentes EDOF y AOMF en días diferentes. Las mediciones objetivas incluyeron la agudeza visual de alto y bajo contraste (HCVA/LCVA, log MAR), y la sensibilidad al contraste (unidades log) a 6 m, HCVA a 70 cm, 50 cm y 40 cm, y estereopsis (segundos de arco) a 40 cm. La HCVA a 70 cm, 50 cm y 40 cm se midió como «agudeza de confort» en lugar de la agudeza de resolución convencional. Las mediciones subjetivas incluyeron la claridad de visión y la visión fantasma (ghosting) a distancia, la satisfacción con la visión general intermedia y lejana, el confort ocular (escala de clasificación numérica de 1a 10) y la adquisición de lentes de contacto (respuesta sí/no). El análisis estadístico incluyó la prueba ANOVA con medidas repetidas, la prueba de t pareada, y la prueba de McNemar. Resultados: La significación de las diferencias entre los tipos de lentes fue independiente de los estratos (p ≥ 0,119). Los resultados de EDOF fueron considerablemente mejores que los de AOMF en cuanto a HCVA a 40 cm (0,42 ± 0,18 frente a 0,48 ± 0,22, p = 0,024), estereopsis (98 ± 88 frente a 141 ± 114, p < 0,001), claridad de visión intermedia (8,5 ± 16 frente a 7,7 ± 1,9, p = 0,006) y próxima (7,3 ± 2,5 frente a 6,2 ± 2,5, p = 0,005), ausencia de visión fantasma (p = 0,012), satisfacción con la visión general (7,5 ± 1,7 frente a 6,4 ± 2,2, p < 0,001) y confort ocular (9,0 ± 1,0 frente a 8,3 ± 1,7, p = 0,002). Un número considerable de participantes optó por adquirir únicamente EDOF (33% frente al 6%, p = 0,003). No se produjeron diferencias significativas entre los dos tipos de lentes en relación a las mediciones objetivas a 6 m, ni a la claridad de visión lejana (p ≥ 0,356). Conclusiones: Las lentes EDOF proporcionaron un mejor rendimiento de la visión intermedia y próxima en pacientes con presbicia que las lentes AOMF, sin que se produjeran diferencias en cuanto a visión lejana con el uso a corto plazo (AU)

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.

Short-term visual performance of soft multifocal contact lenses for presbyopia.

PURPOSE: To compare visual acuity (VA), contrast sensitivity, stereopsis, and subjective visual performance of Acuvue® Oasys® for Presbyopia (AOP), Air Optix® Aqua Multifocal (AOMF), and Air Optix® Aqua Single Vision (AOSV) lenses in patients with presbyopia. METHODS: A single-blinded crossover trial was conducted. Twenty patients with mild presbyopia (add ≤+1.25 D) and 22 with moderate/severe presbyopia (add ≥+1.50 D) who wore lenses bilaterally for 1 h, with a minimum overnight washout period between the use of each lens. Measurements included high- and low-contrast visual acuity (HCVA and LCVA, respectively) at a distance, contrast sensitivity (CS) at a distance, HCVA at intermediate (70 cm) and near (50 cm & 40 cm) distances, stereopsis, and subjective questionnaires regarding vision clarity, ghosting, overall vision satisfaction, and comfort. The test variables were compared among the lens types using repeated-measures ANOVA. RESULTS: Distance variables (HCVA, LCVA, and CS) were significantly worse with multifocal lens than with AOSV lens (p≤0.008), except for AOMF lens in the mild presbyopia group in which no significant difference was observed (p>0.05). Multifocal lenses had significantly greater HCVA at 40 cm than AOSV lens (p≤0.026). AOMF lens had greater intermediate HCVA than AOP lens (p<0.03). AOP lens demonstrated greater improvements in stereopsis than AOMF and AOSV lens in the moderate/severe presbyopia group (p≤0.03). Few significant differences in subjective variables were observed, with no significant difference in the overall vision satisfaction observed between lens types (p>0.05). The proportions of patients willing to buy AOSV, AOMF, and AOP lenses were 20%, 40%, and 50%, respectively, in the mild presbyopia group and 14%, 32%, and 23%, respectively, in the moderate/severe presbyopia group; however, these differences were not statistically significant (p≥0.159). CONCLUSIONS: Further development of multifocal lenses is required before significant advantages of multifocal lenses over single vision lens are observed in patients with presbyopia.

Short-term visual performance of soft multifocal contact lenses for presbyopia / Desempenho visual de curto prazo de présbitas usando diferentes lentes de contato multifocais hidrofílicas

ABSTRACT Purpose: To compare visual acuity (VA), contrast sensitivity, stereopsis, and subjective visual performance of Acuvue® Oasys® for Presbyopia (AOP), Air Optix® Aqua Multifocal (AOMF), and Air Optix® Aqua Single Vision (AOSV) lenses in patients with presbyopia. Methods: A single-blinded crossover trial was conducted. Twenty patients with mild presbyopia (add ≤+1.25 D) and 22 with moderate/severe presbyopia (add ≥+1.50 D) who wore lenses bilaterally for 1 h, with a minimum overnight washout period between the use of each lens. Measurements included high- and low-contrast visual acuity (HCVA and LCVA, respectively) at a distance, contrast sensitivity (CS) at a distance, HCVA at intermediate (70 cm) and near (50 cm & 40 cm) distances, stereopsis, and subjective questionnaires regarding vision clarity, ghosting, overall vision satisfaction, and comfort. The test variables were compared among the lens types using repeated-measures ANOVA. Results: Distance variables (HCVA, LCVA, and CS) were significantly worse with multifocal lens than with AOSV lens (p≤0.008), except for AOMF lens in the mild presbyopia group in which no significant difference was observed (p>0.05). Multifocal lenses had significantly greater HCVA at 40 cm than AOSV lens (p≤0.026). AOMF lens had greater intermediate HCVA than AOP lens (p<0.03). AOP lens demonstrated greater improvements in stereopsis than AOMF and AOSV lens in the moderate/severe presbyopia group (p≤0.03). Few significant differences in subjective variables were observed, with no significant difference in the overall vision satisfaction observed between lens types (p>0.05). The proportions of patients willing to buy AOSV, AOMF, and AOP lenses were 20%, 40%, and 50%, respectively, in the mild presbyopia group and 14%, 32%, and 23%, respectively, in the moderate/severe presbyopia group; however, these differences were not statistically significant (p≥0.159). Conclusions: Further development of multifocal lenses is required before significant advantages of multifocal lenses over single vision lens are observed in patients with presbyopia.

RESUMO Objetivo: Comparar a acuidade visual, sensibilidade ao contraste, estereopsia e desempenho visual subjetivo de présbitas usando lentes de contato Acuvue Oasys para presbiopia (AOP), Air Optix Aqua Multifocal (AOMF) e Air Optix Aqua Single Vision (AOSV). Método: Foi realizado estudo mascarado simples, cruzado. Vinte pacientes com presbiopia baixa (adição ≤+1,25 D) e 22 com presbiopia média/alta (adição ≥+1,50 D) usaram cada lente bilateralmente durante 1 hora, com descanso mínimo de uma noite entre as diferentes lentes. As medições incluíram acuidade visual para distância em alto e baixo contraste (HCVA, LCVA), sensibilidade ao contraste para distância (CS), HCVA para distância intermediária (70 cm) e para perto (50 cm e 40 cm), estereopsia e questionários subjetivos sobre nitidez visual, fantasmas, satisfação visão geral e conforto. As variáveis foram comparadas entre os tipos de lentes, utilizando medidas repetidas ANOVA. Resultados: As variáveis para distância (HCVA, LCVA, CS) foram significativamente piores com as multifocais em relação a AOSV (p≤0,008), exceto para AOMF no grupo de baixa adição, que não foi significativamente diferente (p>0,05). As multifocais foram significativamente melhores do que a AOSV para HCVA em 40 cm (p≤0,026). AOMF superou AOP para HCVA intermediária (p<0,03). AOP superou AOMF e AOSV em relação à estereopsia no grupo de presbiopia médio/alto (p≤0,03). Houve poucas diferenças significativas nas variáveis subjetivas, mas a satisfação visual global não foi significativamente diferente entre as lentes (p>0,05). A disposição para comprar lentes AOSV, AOMF e AOP foi: 20%, 40%, 50%, respectivamente, no grupo de presbiopia baixa; 14%, 32%, 23% no grupo de presbiopia média/alto, mas essas diferenças não foram estatisticamente significativas (p≥0,159). Conclusões: Melhorias futuras parecem ser necessárias para produção de uma lente multifocal que forneça aos présbitas uma vantagem significativa sobre a lente de visão única.

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.