Interventions for myopia control in children: a living systematic review and network meta-analysis.

BACKGROUND: Myopia is a common refractive error, where elongation of the eyeball causes distant objects to appear blurred. The increasing prevalence of myopia is a growing global public health problem, in terms of rates of uncorrected refractive error and significantly, an increased risk of visual impairment due to myopia-related ocular morbidity. Since myopia is usually detected in children before 10 years of age and can progress rapidly, interventions to slow its progression need to be delivered in childhood. OBJECTIVES: To assess the comparative efficacy of optical, pharmacological and environmental interventions for slowing myopia progression in children using network meta-analysis (NMA). To generate a relative ranking of myopia control interventions according to their efficacy. To produce a brief economic commentary, summarising the economic evaluations assessing myopia control interventions in children. To maintain the currency of the evidence using a living systematic review approach.  SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE; Embase; and three trials registers. The search date was 26 February 2022.  SELECTION CRITERIA: We included randomised controlled trials (RCTs) of optical, pharmacological and environmental interventions for slowing myopia progression in children aged 18 years or younger. Critical outcomes were progression of myopia (defined as the difference in the change in spherical equivalent refraction (SER, dioptres (D)) and axial length (mm) in the intervention and control groups at one year or longer) and difference in the change in SER and axial length following cessation of treatment ('rebound').  DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods. We assessed bias using RoB 2 for parallel RCTs. We rated the certainty of evidence using the GRADE approach for the outcomes: change in SER and axial length at one and two years. Most comparisons were with inactive controls. MAIN RESULTS: We included 64 studies that randomised 11,617 children, aged 4 to 18 years. Studies were mostly conducted in China or other Asian countries (39 studies, 60.9%) and North America (13 studies, 20.3%). Fifty-seven studies (89%) compared myopia control interventions (multifocal spectacles, peripheral plus spectacles (PPSL), undercorrected single vision spectacles (SVLs), multifocal soft contact lenses (MFSCL), orthokeratology, rigid gas-permeable contact lenses (RGP); or pharmacological interventions (including high- (HDA), moderate- (MDA) and low-dose (LDA) atropine, pirenzipine or 7-methylxanthine) against an inactive control. Study duration was 12 to 36 months. The overall certainty of the evidence ranged from very low to moderate. Since the networks in the NMA were poorly connected, most estimates versus control were as, or more, imprecise than the corresponding direct estimates. Consequently, we mostly report estimates based on direct (pairwise) comparisons below. At one year, in 38 studies (6525 participants analysed), the median change in SER for controls was -0.65 D. The following interventions may reduce SER progression compared to controls: HDA (mean difference (MD) 0.90 D, 95% confidence interval (CI) 0.62 to 1.18), MDA (MD 0.65 D, 95% CI 0.27 to 1.03), LDA (MD 0.38 D, 95% CI 0.10 to 0.66), pirenzipine (MD 0.32 D, 95% CI 0.15 to 0.49), MFSCL (MD 0.26 D, 95% CI 0.17 to 0.35), PPSLs (MD 0.51 D, 95% CI 0.19 to 0.82), and multifocal spectacles (MD 0.14 D, 95% CI 0.08 to 0.21). By contrast, there was little or no evidence that RGP (MD 0.02 D, 95% CI -0.05 to 0.10), 7-methylxanthine (MD 0.07 D, 95% CI -0.09 to 0.24) or undercorrected SVLs (MD -0.15 D, 95% CI -0.29 to 0.00) reduce progression.  At two years, in 26 studies (4949 participants), the median change in SER for controls was -1.02 D. The following interventions may reduce SER progression compared to controls: HDA (MD 1.26 D, 95% CI 1.17 to 1.36), MDA (MD 0.45 D, 95% CI 0.08 to 0.83), LDA (MD 0.24 D, 95% CI 0.17 to 0.31), pirenzipine (MD 0.41 D, 95% CI 0.13 to 0.69), MFSCL (MD 0.30 D, 95% CI 0.19 to 0.41), and multifocal spectacles  (MD 0.19 D, 95% CI 0.08 to 0.30). PPSLs (MD 0.34 D, 95% CI -0.08 to 0.76) may also reduce progression, but the results were inconsistent. For RGP, one study found a benefit and another found no difference with control. We found no difference in SER change for undercorrected SVLs (MD 0.02 D, 95% CI -0.05 to 0.09). At one year, in 36 studies (6263 participants), the median change in axial length for controls was 0.31 mm. The following interventions may reduce axial elongation compared to controls: HDA (MD -0.33 mm, 95% CI -0.35 to 0.30), MDA (MD -0.28 mm, 95% CI -0.38 to -0.17), LDA (MD -0.13 mm, 95% CI -0.21 to -0.05), orthokeratology (MD -0.19 mm, 95% CI -0.23 to -0.15), MFSCL (MD -0.11 mm, 95% CI -0.13 to -0.09), pirenzipine (MD -0.10 mm, 95% CI -0.18 to -0.02), PPSLs (MD -0.13 mm, 95% CI -0.24 to -0.03), and multifocal spectacles (MD -0.06 mm, 95% CI -0.09 to -0.04). We found little or no evidence that RGP (MD 0.02 mm, 95% CI -0.05 to 0.10), 7-methylxanthine (MD 0.03 mm, 95% CI -0.10 to 0.03) or undercorrected SVLs (MD 0.05 mm, 95% CI -0.01 to 0.11) reduce axial length. At two years, in 21 studies (4169 participants), the median change in axial length for controls was 0.56 mm. The following interventions may reduce axial elongation compared to controls: HDA (MD -0.47mm, 95% CI -0.61 to -0.34), MDA (MD -0.33 mm, 95% CI -0.46 to -0.20), orthokeratology (MD -0.28 mm, (95% CI -0.38 to -0.19), LDA (MD -0.16 mm, 95% CI -0.20 to  -0.12), MFSCL (MD -0.15 mm, 95% CI -0.19 to -0.12), and multifocal spectacles (MD -0.07 mm, 95% CI -0.12 to -0.03). PPSL may reduce progression (MD -0.20 mm, 95% CI -0.45 to 0.05) but results were inconsistent. We found little or no evidence that undercorrected SVLs (MD -0.01 mm, 95% CI -0.06 to 0.03) or RGP (MD 0.03 mm, 95% CI -0.05 to 0.12) reduce axial length. There was inconclusive evidence on whether treatment cessation increases myopia progression. Adverse events and treatment adherence were not consistently reported, and only one study reported quality of life. No studies reported environmental interventions reporting progression in children with myopia, and no economic evaluations assessed interventions for myopia control in children. AUTHORS' CONCLUSIONS: Studies mostly compared pharmacological and optical treatments to slow the progression of myopia with an inactive comparator. Effects at one year provided evidence that these interventions may slow refractive change and reduce axial elongation, although results were often heterogeneous. A smaller body of evidence is available at two or three years, and uncertainty remains about the sustained effect of these interventions. Longer-term and better-quality studies comparing myopia control interventions used alone or in combination are needed, and improved methods for monitoring and reporting adverse effects.

ANTECEDENTES: La miopía es un defecto de refracción frecuente, en el que el alargamiento del globo ocular hace que los objetos lejanos aparezcan borrosos. La creciente prevalencia de la miopía es un problema de salud pública mundial cada vez mayor, en cuanto a tasas de defectos de refracción no corregidos y un significativamente mayor riesgo de discapacidad visual debido a la morbilidad ocular relacionada con la miopía. Dado que la miopía se suele detectar en niños antes de los 10 años y puede evolucionar rápidamente, las intervenciones para frenar su avance se deben realizar en la infancia. OBJETIVOS: Evaluar la eficacia comparativa de las intervenciones ópticas, farmacológicas y ambientales para frenar la progresión de la miopía en niños mediante un metanálisis en red (MAR). Generar una clasificación relativa de las intervenciones de control de la miopía en función de su eficacia. Elaborar un breve comentario económico que resuma las evaluaciones económicas de las intervenciones de control de la miopía en niños. Mantener la vigencia de la evidencia mediante un enfoque de revisión sistemática continua. MÉTODOS DE BÚSQUEDA: Se realizaron búsquedas en CENTRAL (que contiene el Registro de ensayos del Grupo Cochrane de Salud ocular y de la visión [Cochrane Eyes and Vision]), MEDLINE; Embase; y en tres registros de ensayos. La fecha de búsqueda fue el 26 de febrero de 2022. CRITERIOS DE SELECCIÓN: Se incluyeron ensayos controlados aleatorizados (ECA) de intervenciones ópticas, farmacológicas y ambientales para retrasar la progresión de la miopía en niños de hasta 18 años. Los desenlaces fundamentales fueron la progresión de la miopía (definida como la diferencia en el cambio del equivalente esférico de la refracción [EER, dioptrías (D)] y la longitud axial [mm] en los grupos de intervención y control al año o más) y la diferencia en el cambio del EER y la longitud axial tras el cese del tratamiento ("rebote"). OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Se utilizaron los métodos Cochrane estándar. El sesgo se evaluó mediante la herramienta RoB 2 en el caso de los ECA paralelos. La certeza de la evidencia se calificó mediante el método GRADE para los desenlaces: cambio del EER y la longitud axial al año y a los dos años. La mayoría de las comparaciones se realizaron con controles inactivos. RESULTADOS PRINCIPALES: Se incluyeron 64 estudios que asignaron al azar a 11 617 niños de cuatro a 18 años de edad. Los estudios se realizaron principalmente en China u otros países asiáticos (39 estudios; 60,9%) y Norteamérica (13 estudios; 20,3%). Cincuenta y siete estudios (89%) compararon intervenciones de control de la miopía (gafas multifocales, gafas periféricas plus [PPSL por sus siglas en inglés], gafas monofocales [SVL por sus siglas en inglés] subcorregidas, lentes de contacto multifocales blandas [MFSCL por sus siglas en inglés], ortoqueratología, lentes de contacto rígidas permeables al gas [RGP por sus siglas en inglés]); o intervenciones farmacológicas (incluidas atropina a dosis alta, media y baja, pirenzipina o 7­metilxantina) contra un control inactivo. La duración de los estudios fue de 12 a 36 meses. La certeza global de la evidencia varió entre muy baja y moderada. Debido a que las redes del MAR estaban mal conectadas, la mayoría de las estimaciones versus control fueron tan imprecisas o más que las correspondientes estimaciones directas. En consecuencia, a continuación se presentan principalmente estimaciones basadas en comparaciones directas (por pares). Al año, en 38 estudios (6525 participantes analizados), la mediana del cambio del EER para los controles fue de ­0,65 D. Las siguientes intervenciones podrían reducir la progresión del EER en comparación con los controles: atropina a dosis alta (diferencia de medias [DM] 0,90 D; intervalo de confianza [IC] del 95%: 0,62 a 1,18), atropina a dosis media (DM 0,65 D; IC del 95%: 0,27 a 1,03), atropina a dosis baja (DM 0,38 D; IC del 95%: 0,10 a 0,66), pirenzipina (DM 0,32 D; IC del 95%: 0,15 a 0,49), MFSCL (DM 0,26 D; IC del 95%: 0,17 a 0,35), PPSL (DM 0,51 D; IC del 95%: 0,19 a 0,82) y gafas multifocales (DM 0,14 D; IC del 95%: 0,08 a 0,21). Por el contrario, hubo poca o ninguna evidencia de que las RGP (DM 0,02 D; IC del 95%: ­0,05 a 0,10), la 7­metilxantina (DM 0,07 D; IC del 95%: ­0,09 a 0,24) o las SVL subcorregidas (DM ­0,15 D; IC del 95%: ­0,29 a 0,00) redujeran la progresión. A los dos años, en 26 estudios (4949 participantes), el cambio medio del EER para los controles fue de ­1,02 D. Las siguientes intervenciones podrían reducir la progresión del EER en comparación con los controles: atropina a dosis alta (DM 1,26 D; IC del 95%: 1,17 a 1,36), atropina a dosis media (DM 0,45 D; IC del 95%: 0,08 a 0,83), atropina a dosis baja (DM 0,24 D; IC del 95%: 0,17 a 0,31), pirenzipina (DM 0,41 D; IC del 95%: 0,13 a 0,69), MFSCL (DM 0,30 D; IC del 95%: 0,19 a 0,41) y gafas multifocales (DM 0,19 D; IC del 95%: 0,08 a 0,30). Las PPSL (DM 0,34 D; IC del 95%: ­0,08 a 0,76) también podrían reducir la progresión, pero los resultados no fueron consistentes. Para las RGP, un estudio encontró un efecto beneficioso y otro no encontró diferencias con el control. No se observaron diferencias en el cambio del EER para las SVL subcorregidas (DM 0,02 D; IC del 95%: ­0,05 a 0,09). Al año, en 36 estudios (6.263 participantes), el cambio medio en la longitud axial de los controles fue de 0,31 mm. Las siguientes intervenciones podrían reducir la elongación axial en comparación con los controles: atropina a dosis alta (DM ­0,33 mm; IC 95%: ­0,35 a 0,30), atropina a dosis media (DM ­0,28 mm; IC 95%: ­0,38 a ­0,17), atropina a dosis baja (DM ­0,13 mm; IC 95%: ­0,21 a ­0,05), ortoqueratología (DM ­0,19 mm; IC 95%: ­0,23 a ­0,15), MFSCL (DM ­0,11 mm; IC del 95%: ­0,13 a ­0,09), pirenzipina (DM ­0,10 mm; IC del 95%: ­0,18 a ­0,02), PPSL (DM ­0,13 mm; IC del 95%: ­0,24 a ­0,03) y gafas multifocales (DM ­0,06 mm; IC del 95%: ­0,09 a ­0,04). Se encontró poca o ninguna evidencia de que las RGP (DM 0,02 mm; IC del 95%: ­0,05 a 0,10), la 7­metilxantina (DM 0,03 mm; IC del 95%: ­0,10 a 0,03) o las SVL subcorregidas (DM 0,05 mm; IC del 95%: ­0,01 a 0,11) reduzcan la longitud axial. A los dos años, en 21 estudios (4169 participantes), la mediana del cambio en la longitud axial de los controles fue de 0,56 mm. Las siguientes intervenciones podrían reducir la elongación axial en comparación con los controles: atropina a dosis alta (DM ­0,47 mm; IC del 95%: ­0,61 a ­0,34), atropina a dosis media (DM ­0,33 mm; IC del 95%: ­0,46 a ­0,20), ortoqueratología (DM ­0,28 mm; IC del 95%: ­0,38 a ­0,19), atropina a dosis baja (DM ­0,16 mm; IC del 95%: ­0,20 a ­0,12), MFSCL (DM ­0,15 mm; IC del 95%: ­0,19 a ­0,12) y gafas multifocales (DM ­0,07 mm; IC del 95%: ­0,12 a ­0,03). Las PPSL podrían reducir la progresión (DM ­0,20 mm; IC del 95%: ­0,45 a 0,05), pero los resultados no fueron consistentes. Se encontró poca o ninguna evidencia de que las SVL subcorregidas (DM ­0,01 mm; IC del 95%: ­0,06 a 0,03) o las RGP (DM 0,03 mm; IC del 95%: ­0,05 a 0,12) reduzcan la longitud axial. No hubo evidencia concluyente sobre si el abandono del tratamiento aumenta la progresión de la miopía. Los eventos adversos y la adherencia al tratamiento no se comunicaron de forma consistente, y solo un estudio informó sobre la calidad de vida. Ningún estudio proporcionó información sobre intervenciones ambientales que informaran sobre la progresión en niños con miopía y ninguna evaluación económica analizó intervenciones para el control de la miopía en niños. CONCLUSIONES DE LOS AUTORES: La mayoría de los estudios compararon tratamientos farmacológicos y ópticos para enlentecer la progresión de la miopía con un comparador inactivo. Los efectos al año demostraron que estas intervenciones podrían ralentizar el cambio refractivo y reducir el alargamiento axial, aunque a menudo los resultados fueron heterogéneos. El conjunto de evidencia disponible a los dos o tres años fue más escaso, y persiste la incertidumbre sobre el efecto sostenido de estas intervenciones. Se necesitan estudios a más largo plazo y de mejor calidad que comparen las intervenciones para el control de la miopía utilizadas solas o en combinación, así como métodos mejorados de seguimiento y notificación de los efectos adversos.

Accommodation in Children after 4.7 Years of Multifocal Contact Lens Wear in the BLINK Study Randomized Clinical Trial.

SIGNIFICANCE: When worn for myopia control in children, soft multifocal contact lenses with a +2.50 D add reduced the accommodative response over a 3-year period, but wearing them for more than 4 years did not affect accommodative amplitudes, lag, or facility. PURPOSE: This study aimed to compare the accommodative response to a 3D stimulus between single-vision, +1.50-D add, and +2.50-D add multifocal contact lens wearers during 3 years of contact lens wear and then to compare accommodative amplitude, lag, and facility between the three groups after an average of 4.7 years of wear. METHODS: Bifocal Lenses In Nearsighted Kids study participants aged 7 to 11 years old were randomly assigned to wear single-vision, +1.50-D add, or +2.50-D add soft contact lenses (CooperVision, Pleasanton, CA). The accommodative response to a 3D stimulus was measured at baseline and annually for 3 years. After 4.7 years, we measured objective accommodative amplitudes, lead/lag, and binocular facility with ±2.00-D flippers. We compared the three accommodative measures using multivariate analysis of variance (MANOVA), adjusting for clinic site, sex, and age group (7 to 9 or 10 to 11 years). RESULTS: The +2.50-D add contact lens wearers exhibited lower accommodative response than the single-vision contact lens wearers for 3 years, but the +1.50-D add contact lens wearers exhibited only lower accommodative response than did the single-vision contact lens wearers for 2 years. After adjustment for clinic site, sex, and age group, there were no statistically significant or clinically meaningful differences between the three treatment groups for accommodative amplitude (MANOVA, P = .49), accommodative lag (MANOVA, P = .41), or accommodative facility (MANOVA, P = .87) after an average of 4.7 years of contact lens wear. CONCLUSIONS: Almost 5 years of multifocal contact lens wear did not affect the accommodative amplitude, lag, or facility of children.

Quality of life after wearing multifocal contact lenses for myopia control for 2 weeks in the BLINK Study.

PURPOSE: To validate Pediatric Refractive Error Profile 2 (PREP2) subscales that can be used to evaluate contact lens wearers and compare vision-specific quality of life measurements between children wearing multifocal and single vision contact lenses for 2 weeks. METHODS: Two hundred and ninety-four myopic children aged 7-11 years (inclusive) were enrolled in the 3-year, double-masked Bifocal Lenses In Nearsighted Kids (BLINK) Study. Participants completed the PREP2 survey after having worn contact lenses for 2 weeks. The Vision, Symptoms, Activities and Overall PREP2 subscales were used to compare participants' subjective assessment while wearing +1.50 or +2.50 D add multifocal or single vision contact lenses. Rasch analysis was used to validate each subscale and to compare participants' subjective assessment of contact lens wear. RESULTS: Item fit to the Rasch model was good for all scales, with no individual items having infit mean square statistics outside the recommended range (0.7-1.3). Response category function was acceptable for all subscales, with ordered category thresholds. Measurement precision, assessed by the Rasch person reliability statistic, was less than ideal (≥0.8) for three of the subscales, but met the minimum acceptable standard of 0.5. Scores for the Vision subscale differed by treatment assignment (p = 0.03), indicating that participants with the highest add power reported statistically worse quality of vision, although the difference was only 3.9 units on a scale of 1-100. Girls reported fewer symptoms than boys (p = 0.006), but there were no other differences between boys and girls. CONCLUSIONS: Rasch analysis demonstrates that the PREP2 survey is a valid instrument for assessing refractive error-specific quality of life. These results suggest that vision-related quality of life is not meaningfully affected by 2 weeks of soft multifocal contact lens wear for myopia control.

Effect of Combining 0.01% Atropine with Soft Multifocal Contact Lenses on Myopia Progression in Children.

SIGNIFICANCE: Combining 0.01% atropine with soft multifocal contact lenses (SMCLs) failed to demonstrate better myopia control than SMCLs alone. PURPOSE: The Bifocal & Atropine in Myopia (BAM) Study investigated whether combining 0.01% atropine and SMCLs with +2.50-D add power leads to greater slowing of myopia progression and axial elongation than SMCLs alone. METHODS: Participants of the BAM Study wore SMCLs with +2.50-D add power daily and administered 0.01% atropine eye drops nightly (n = 46). The BAM subjects (bifocal-atropine) were age-matched to 46 participants in the Bifocal Lenses in Nearsighted Kids Study who wore SMCLs with +2.50-D add power (bifocal) and 46 Bifocal Lenses in Nearsighted Kids participants who wore single-vision contact lenses (single vision). The primary outcome was the 3-year change in spherical equivalent refractive error determined by cycloplegic autorefraction, and the 3-year change in axial elongation was also evaluated. RESULTS: Of the total 138 subjects, the mean ± standard deviation age was 10.1 ± 1.2 years, and the mean ± standard deviation spherical equivalent was -2.28 ± 0.89 D. The 3-year adjusted mean myopia progression was -0.52 D for bifocal-atropine, -0.55 D for bifocal, and -1.09 D for single vision. The difference in myopia progression was 0.03 D (95% confidence interval [CI], -0.14 to 0.21 D) for bifocal-atropine versus bifocal and 0.57 D (95% CI, 0.38 to 0.77 D) for bifocal-atropine versus single vision. The 3-year adjusted axial elongation was 0.31 mm for bifocal-atropine, 0.39 mm for bifocal, and 0.68 mm for single vision. The difference in axial elongation was -0.08 mm (95% CI, -0.16 to 0.002 mm) for bifocal-atropine versus bifocal and -0.37 mm (95% CI, -0.46 to -0.28 mm) for bifocal-atropine versus single vision. CONCLUSIONS: Adding 0.01% atropine to SMCLs with +2.50-D add power failed to demonstrate better myopia control than SMCLs alone.

Ocular and Nonocular Adverse Events during 3 Years of Soft Contact Lens Wear in Children.

SIGNIFICANCE: Children are being fitted at younger ages with soft contact lenses for myopia control. This 3-year investigation of adverse events related to contact lens wear in 7- to 11-year-old participants helps optometrists understand what to expect when fitting children with soft contact lenses. PURPOSE: The purpose of this article is to report the frequency and type of ocular and nonocular adverse events related to soft contact lens wear in children. METHODS: Seven- to 11-year-old children wore soft contact lenses for 3 years. Adverse events were defined by a slit-lamp examination finding of grade 3 or worse; parental report of a clinically meaningful change (determined by the examiner) in eyes, vision, or health; or a clinically meaningful response (determined by examiner) to a symptom checklist. Adverse events were categorized and reported by examiners and finalized by the Executive Committee. The presence or absence of an infiltrate and a list of diagnoses was determined at the conclusion of the study. RESULTS: The 294 participants wore their contact lenses 73.0 ± 26.5 hours per week, and 220 (74.8%) encountered at least 1 adverse event. Of the 432 adverse events, 75.2% were ocular, and 24.8% were nonocular. Contact lens wear was probably or definitely related to 60.6% of the ocular and 2.8% of the nonocular adverse events. None of the ocular adverse events were serious or severe or caused permanent contact lens discontinuation. The corneal infiltrate incidence was 185 cases per 10,000 patient-years of wear (95% confidence interval, 110 to 294). The incidence of moderate ocular adverse events that were definitely or probably related to contact lens wear was 405 cases per 10,000 patient-years of wear (95% confidence interval, 286 to 557). CONCLUSIONS: The adverse events experienced by 7- to 11-year-old myopic children rarely required meaningful treatment and never led to permanent discontinuation of contact lens wear or loss of best-corrected vision.

Visual Performance with Spherical and Multifocal Contact Lenses in a Pediatric Population.

SIGNIFICANCE: This pilot study compared subjective and objective vision of children wearing single-vision and +2.00, +3.00, and +4.00 D add power soft multifocal contact lenses to determine whether the higher add power-thought to provide better myopia control-resulted in visual compromise. PURPOSE: This study aimed to determine the maximum add power children wearing center-distance soft multifocal contact lenses could accept objectively and subjectively. METHODS: Myopic children were assigned in random order to wear omafilcon A single-vision or multifocal "D" contact lenses with +2.00, +3.00, or +4.00 D add power for 1 week each. High-contrast distance and near visual acuity, low-contrast distance visual acuity, and contrast sensitivity were measured at each visit along with a quality of vision questionnaire to assess their vision. The Friedman test was performed to evaluate the impact of add power on all outcome measures. RESULTS: Eleven subjects were enrolled, and nine subjects completed the study. The median age of completed subjects was 11 years. Median logMAR low-contrast distance visual acuity was reduced in the +3.00 (+0.20) and +4.00 (+0.28) D add lenses compared with the +2.00 (+0.16) D add and single-vision lenses (+0.10, P < .001). All three multifocal lenses resulted in reduced contrast sensitivity (+1.35 to +1.40) compared with single-vision lenses (+1.60, P < .001). In general, +3.00 and +4.00 D add lenses resulted in worse glare/starbursts, ghost images, computer vision, changing fixation distance, and overall vision, but results varied. There were no differences among the lenses with respect to subjective assessments of distance vision, near vision, strain or tiredness, contact lens comfort, or sporting activities. CONCLUSIONS: The +3.00 D and higher add powers result in more objective and subjective vision-related issues than single-vision lenses, but the +2.00 D add multifocal lenses were well tolerated.

Contact Lens Adaption in Neophytes.

SIGNIFICANCE: Clinicians commonly either recommend patients begin contact lens (CL) wear full time or suggest that patients should gradually increase their wear times during the first few days of wear. This study found no differences between these two wear schedules, suggesting that patient preference may be the best schedule. PURPOSE: The purpose of this study was to determine if there are any clinical differences in neophyte, 2-week, reusable soft CL wearers who were randomized to either a full-time or a gradually increasing wear time schedule. METHODS: This was an investigator-masked, three-visit, randomized, clinical trial. Participants were randomized to wear their CLs full time starting on the first day or gradually starting with 2 hours of wear on the first day and increasing wear by 2 hours each day until 8 hours or more of wear per day was achieved. Symptoms (Ocular Surface Disease Index and visual analog scale) and ocular surface signs (tear breakup time, extent of corneal staining, and Schirmer test I) were evaluated at each visit. RESULTS: A total of 25 participants were randomized, with 21 participants completing at least 1 week of follow-up. Completed participants had a mean ± standard deviation age of 23.5 ± 3.0 years, and 48% were female. No significant between-group differences were found when comparing the full-time and gradual wear time schedule groups at 2 weeks (all, P > .32): Ocular Surface Disease Index (10.8 ± 8.5 vs. 16.3 ± 18.8), visual analog scale (89.0 ± 9.7 vs. 81.8 ± 18.7), tear breakup time (11.7 ± 7.0 vs. 9.8 ± 2.7), extent of corneal staining (0.0 ± 0.1 vs. 0.3 ± 0.5), or Schirmer test I (15.9 ± 8.8 vs. 21.2 ± 12.5). CONCLUSIONS: No between-group differences were found for any metric evaluated, which suggests that the best wear schedule may be the one that best suits the neophyte CL wearer's lifestyle.

Interventions to slow progression of myopia in children.

BACKGROUND: Nearsightedness (myopia) causes blurry vision when one is looking at distant objects. Interventions to slow the progression of myopia in children include multifocal spectacles, contact lenses, and pharmaceutical agents. OBJECTIVES: To assess the effects of interventions, including spectacles, contact lenses, and pharmaceutical agents in slowing myopia progression in children. SEARCH METHODS: We searched CENTRAL; Ovid MEDLINE; Embase.com; PubMed; the LILACS Database; and two trial registrations up to February 2018. A top up search was done in February 2019. SELECTION CRITERIA: We included randomized controlled trials (RCTs). We excluded studies when most participants were older than 18 years at baseline. We also excluded studies when participants had less than -0.25 diopters (D) spherical equivalent myopia. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods. MAIN RESULTS: We included 41 studies (6772 participants). Twenty-one studies contributed data to at least one meta-analysis. Interventions included spectacles, contact lenses, pharmaceutical agents, and combination treatments. Most studies were conducted in Asia or in the United States. Except one, all studies included children 18 years or younger. Many studies were at high risk of performance and attrition bias. Spectacle lenses: undercorrection of myopia increased myopia progression slightly in two studies; children whose vision was undercorrected progressed on average -0.15 D (95% confidence interval [CI] -0.29 to 0.00; n = 142; low-certainty evidence) more than those wearing fully corrected single vision lenses (SVLs). In one study, axial length increased 0.05 mm (95% CI -0.01 to 0.11) more in the undercorrected group than in the fully corrected group (n = 94; low-certainty evidence). Multifocal lenses (bifocal spectacles or progressive addition lenses) yielded small effect in slowing myopia progression; children wearing multifocal lenses progressed on average 0.14 D (95% CI 0.08 to 0.21; n = 1463; moderate-certainty evidence) less than children wearing SVLs. In four studies, axial elongation was less for multifocal lens wearers than for SVL wearers (-0.06 mm, 95% CI -0.09 to -0.04; n = 896; moderate-certainty evidence). Three studies evaluating different peripheral plus spectacle lenses versus SVLs reported inconsistent results for refractive error and axial length outcomes (n = 597; low-certainty evidence). Contact lenses: there may be little or no difference between vision of children wearing bifocal soft contact lenses (SCLs) and children wearing single vision SCLs (mean difference (MD) 0.20D, 95% CI -0.06 to 0.47; n = 300; low-certainty evidence). Axial elongation was less for bifocal SCL wearers than for single vision SCL wearers (MD -0.11 mm, 95% CI -0.14 to -0.08; n = 300; low-certainty evidence). Two studies investigating rigid gas permeable contact lenses (RGPCLs) showed inconsistent results in myopia progression; these two studies also found no evidence of difference in axial elongation (MD 0.02mm, 95% CI -0.05 to 0.10; n = 415; very low-certainty evidence). Orthokeratology contact lenses were more effective than SVLs in slowing axial elongation (MD -0.28 mm, 95% CI -0.38 to -0.19; n = 106; moderate-certainty evidence). Two studies comparing spherical aberration SCLs with single vision SCLs reported no difference in myopia progression nor in axial length (n = 209; low-certainty evidence). Pharmaceutical agents: at one year, children receiving atropine eye drops (3 studies; n = 629), pirenzepine gel (2 studies; n = 326), or cyclopentolate eye drops (1 study; n = 64) showed significantly less myopic progression compared with children receiving placebo: MD 1.00 D (95% CI 0.93 to 1.07), 0.31 D (95% CI 0.17 to 0.44), and 0.34 (95% CI 0.08 to 0.60), respectively (moderate-certainty evidence). Axial elongation was less for children treated with atropine (MD -0.35 mm, 95% CI -0.38 to -0.31; n = 502) and pirenzepine (MD -0.13 mm, 95% CI -0.14 to -0.12; n = 326) than for those treated with placebo (moderate-certainty evidence) in two studies. Another study showed favorable results for three different doses of atropine eye drops compared with tropicamide eye drops (MD 0.78 D, 95% CI 0.49 to 1.07 for 0.1% atropine; MD 0.81 D, 95% CI 0.57 to 1.05 for 0.25% atropine; and MD 1.01 D, 95% CI 0.74 to 1.28 for 0.5% atropine; n = 196; low-certainty evidence) but did not report axial length. Systemic 7-methylxanthine had little to no effect on myopic progression (MD 0.07 D, 95% CI -0.09 to 0.24) nor on axial elongation (MD -0.03 mm, 95% CI -0.10 to 0.03) compared with placebo in one study (n = 77; moderate-certainty evidence). One study did not find slowed myopia progression when comparing timolol eye drops with no drops (MD -0.05 D, 95% CI -0.21 to 0.11; n = 95; low-certainty evidence). Combinations of interventions: two studies found that children treated with atropine plus multifocal spectacles progressed 0.78 D (95% CI 0.54 to 1.02) less than children treated with placebo plus SVLs (n = 191; moderate-certainty evidence). One study reported -0.37 mm (95% CI -0.47 to -0.27) axial elongation for atropine and multifocal spectacles when compared with placebo plus SVLs (n = 127; moderate-certainty evidence). Compared with children treated with cyclopentolate plus SVLs, those treated with atropine plus multifocal spectacles progressed 0.36 D less (95% CI 0.11 to 0.61; n = 64; moderate-certainty evidence). Bifocal spectacles showed small or negligible effect compared with SVLs plus timolol drops in one study (MD 0.19 D, 95% CI 0.06 to 0.32; n = 97; moderate-certainty evidence). One study comparing tropicamide plus bifocal spectacles versus SVLs reported no statistically significant differences between groups without quantitative results. No serious adverse events were reported across all interventions. Participants receiving antimuscarinic topical medications were more likely to experience accommodation difficulties (Risk Ratio [RR] 9.05, 95% CI 4.09 to 20.01) and papillae and follicles (RR 3.22, 95% CI 2.11 to 4.90) than participants receiving placebo (n=387; moderate-certainty evidence). AUTHORS' CONCLUSIONS: Antimuscarinic topical medication is effective in slowing myopia progression in children. Multifocal lenses, either spectacles or contact lenses, may also confer a small benefit. Orthokeratology contact lenses, although not intended to modify refractive error, were more effective than SVLs in slowing axial elongation. We found only low or very low-certainty evidence to support RGPCLs and sperical aberration SCLs.

Effect of High Add Power, Medium Add Power, or Single-Vision Contact Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial.

Importance: Slowing myopia progression could decrease the risk of sight-threatening complications. Objective: To determine whether soft multifocal contact lenses slow myopia progression in children, and whether high add power (+2.50 D) slows myopia progression more than medium (+1.50 D) add power lenses. Design, Setting, and Participants: A double-masked randomized clinical trial that took place at 2 optometry schools located in Columbus, Ohio, and Houston, Texas. A total of 294 consecutive eligible children aged 7 to 11 years with -0.75 D to -5.00 D of spherical component myopia and less than 1.00 D astigmatism were enrolled between September 22, 2014, and June 20, 2016. Follow-up was completed June 24, 2019. Interventions: Participants were randomly assigned to wear high add power (n = 98), medium add power (n = 98), or single-vision (n = 98) contact lenses. Main Outcomes and Measures: The primary outcome was the 3-year change in cycloplegic spherical equivalent autorefraction, as measured by the mean of 10 autorefraction readings. There were 11 secondary end points, 4 of which were analyzed for this study, including 3-year eye growth. Results: Among 294 randomized participants, 292 (99%) were included in the analyses (mean [SD] age, 10.3 [1.2] years; 177 [60.2%] were female; mean [SD] spherical equivalent refractive error, -2.39 [1.00] D). Adjusted 3-year myopia progression was -0.60 D for high add power, -0.89 D for medium add power, and -1.05 D for single-vision contact lenses. The difference in progression was 0.46 D (95% CI, 0.29-0.63) for high add power vs single vision, 0.30 D (95% CI, 0.13-0.47) for high add vs medium add power, and 0.16 D (95% CI, -0.01 to 0.33) for medium add power vs single vision. Of the 4 secondary end points, there were no statistically significant differences between the groups for 3 of the end points. Adjusted mean eye growth was 0.42 mm for high add power, 0.58 mm for medium add power, and 0.66 mm for single vision. The difference in eye growth was -0.23 mm (95% CI, -0.30 to -0.17) for high add power vs single vision, -0.16 mm (95% CI, -0.23 to -0.09) for high add vs medium add power, and -0.07 mm (95% CI, -0.14 to -0.01) for medium add power vs single vision. Conclusions and Relevance: Among children with myopia, treatment with high add power multifocal contact lenses significantly reduced the rate of myopia progression over 3 years compared with medium add power multifocal and single-vision contact lenses. However, further research is needed to understand the clinical importance of the observed differences. Trial Registration: ClinicalTrials.gov Identifier: NCT02255474.

Bifocal & Atropine in Myopia Study: Baseline Data and Methods.

SIGNIFICANCE: The Bifocal & Atropine in Myopia (BAM) study aims to determine whether combining 0.01% atropine and +2.50-diopter add center-distance soft bifocal contact lenses (SBCL) slows myopia progression more than SBCL alone. The results could provide significant information on the myopia control effect of combining optical and pharmacological treatments. PURPOSE: This article describes the subject characteristics at baseline, the study methods, and the short-term effects of this combination treatment on visual acuity (VA) and vision-related outcomes. METHODS: Subjects from the BAM study who met the baseline eligibility criteria were dispensed the combination treatment for 2 weeks to determine final eligibility. Outcome measures included VA at near and distance (Bailey-Lovie logMAR charts), near phoria (modified Thorington), accommodative lag (Grand Seiko WAM-5500), and pupil size (NeurOptics VIP-200 Pupillometer). Compliance was monitored using surveys. Two subgroups in the Bifocal Lenses In Nearsighted Kids study, single-vision contact lens wearers and those who wore +2.50-diopter add SBCL, will serve as the age-matched historical controls for BAM study. RESULTS: Forty-nine BAM subjects (9.6 ± 1.4 years) were enrolled; mean spherical equivalent cycloplegic autorefraction was -2.33 ± 1.03 diopters. After 2 weeks of treatment, the best-corrected low-contrast (10% Michelson) distance VA was reduced (pre-treatment, +0.09 ± 0.07; post-treatment, +0.16 ± 0.08; P < .0001), but the high-contrast VA at near or distance was unaffected. Near phoria increased by approximately 2 in the exo direction (P = .01), but the accommodative lag was unchanged. The pupil size was not significantly different between pre-treatment and post-treatment of either the photopic or mesopic condition. Surveys indicated that the subjects wore SBCL 77 ± 22% of waking hours and used atropine 6.4 ± 0.7 days per week. CONCLUSIONS: Two weeks of combination treatment reduced low-contrast distance VA and increased near exophoria slightly, but the subjects were compliant and tolerated the treatment well.

Visual Acuity and Over-refraction in Myopic Children Fitted with Soft Multifocal Contact Lenses.

SIGNIFICANCE: Practitioners fitting contact lenses for myopia control frequently question whether a myopic child can achieve good vision with a high-add multifocal. We demonstrate that visual acuity is not different than spectacles with a commercially available, center-distance soft multifocal contact lens (MFCL) (Biofinity Multifocal "D"; +2.50 D add). PURPOSE: To determine the spherical over-refraction (SOR) necessary to obtain best-corrected visual acuity (BCVA) when fitting myopic children with a center-distance soft MFCL. METHODS: Children (n = 294) aged 7 to 11 years with myopia (spherical component) of -0.75 to -5.00 diopters (D) (inclusive) and 1.00 D cylinder or less (corneal plane) were fitted bilaterally with +2.50 D add Biofinity "D" MFCLs. The initial MFCL power was the spherical equivalent of a standardized subjective refraction, rounded to the nearest 0.25 D step (corneal plane). An SOR was performed monocularly (each eye) to achieve BCVA. Binocular, high-contrast logMAR acuity was measured with manifest spectacle correction and MFCLs with over-refraction. Photopic pupil size was measured with a pupilometer. RESULTS: The mean (±SD) age was 10.3 ± 1.2 years, and the mean (±SD) SOR needed to achieve BCVA was OD: -0.61 ± 0.24 D/OS: -0.58 ± 0.27 D. There was no difference in binocular high-contrast visual acuity (logMAR) between spectacles (-0.01 ± 0.06) and best-corrected MFCLs (-0.01 ± 0.07) (P = .59). The mean (±SD) photopic pupil size (5.4 ± 0.7 mm) was not correlated with best MFCL correction or the over-refraction magnitude (both P ≥ .09). CONCLUSIONS: Children achieved BCVA with +2.50 D add MFCLs that was not different than with spectacles. Children typically required an over-refraction of -0.50 to -0.75 D to achieve BCVA. With a careful over-refraction, these +2.50 D add MFCLs provide good distance acuity, making them viable candidates for myopia control.

Food and Drug Administration, American Academy of Ophthalmology, American Academy of Optometry, American Association for Pediatric Ophthalmology and Strabismus, American Optometric Association, American Society of Cataract and Refractive Surgery, and Contact Lens Association of Ophthalmologists Co-Sponsored Workshop: Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices.

The prevalence of myopia is high and increasing. Approximately 5 billion people around the world are expected to be myopic by the year 2050. Methods to slow the progression of myopia and therefore potentially decrease the associated sight-threatening complications have been the subject of a number of investigations. A workshop, sponsored by the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health, American Academy of Ophthalmology, American Academy of Optometry, American Association for Pediatric Ophthalmology and Strabismus, American Optometric Association, American Society of Cataract and Refractive Surgery, and Contact Lens Association of Ophthalmologists, Inc, convened myopia experts from around the world to discuss principles to consider in the design of clinical trials investigating the effectiveness and safety of myopia control devices. Experts discussed parameters such as study endpoints, duration, enrollment criteria, patient-reported outcomes, recruitment, and retention. The discussions among the experts, FDA, and audience members should help to facilitate the development and evaluation of reasonably safe and effective myopia control devices.

Centration and Decentration of Contact Lenses during Peripheral Gaze.

SIGNIFICANCE: Varying amounts of peripheral defocus reported in previous studies are likely due to whether peripheral defocus is measured while turning the eyes or the head. Contact lenses (CLs) lag when viewing objects in peripheral gaze, so future studies ought to measure peripheral defocus while turning the head to measure defocus through the peripheral add power. PURPOSE: Soft multifocal CL peripheral defocus studies report varying results. To determine whether soft multifocal CL lag when turning the eyes could affect the measurement of peripheral defocus, we measured how much CLs move when looking in different gazes. METHODS: The distance between limbus and CL edge was measured with a slit-lamp reticle magnifier. Centration was measured as the distance between CL edge and limbus at the superior, inferior, nasal, and temporal location of the CL while in primary gaze. Decentration of the CL equals the difference of the distance between the CL edge and limbus while looking centrally and 20 degrees in each direction. All measurements were performed while subjects wore habitual and Proclear Multifocal CL. RESULTS: The average ± SD age of the 40 subjects was 27.8 ± 8.4 years, 65% were female, and SE refractive error was -4.43 ± 2.05 diopters. The soft multifocal CLs decentered 0.09 ± 0.03 mm temporal (P = .006). The soft multifocal CLs lagged 0.49 ± 0.28 mm while looking down (P < .001), 0.24 ± 0.36 mm while looking up (P = .008), 0.58 ± 0.20 mm while looking nasal (P < .001), and 0.35 ± 0.21 mm while looking temporal (P < .001). CONCLUSIONS: Soft multifocal CLs center temporally in primary gaze, and they lag significantly while looking in every direction, but 0.50 mm or more when looking down or nasal, which could affect measurement of peripheral defocus when subjects turn their eyes instead of their head.

A Randomized Trial of Soft Multifocal Contact Lenses for Myopia Control: Baseline Data and Methods.

SIGNIFICANCE: The Bifocal Lenses In Nearsighted Kids (BLINK) study is the first soft multifocal contact lens myopia control study to compare add powers and measure peripheral refractive error in the vertical meridian, so it will provide important information about the potential mechanism of myopia control. PURPOSE: The BLINK study is a National Eye Institute-sponsored, double-masked, randomized clinical trial to investigate the effects of soft multifocal contact lenses on myopia progression. This article describes the subjects' baseline characteristics and study methods. METHODS: Subjects were 7 to 11 years old, had -0.75 to -5.00 spherical component and less than 1.00 diopter (D) astigmatism, and had 20/25 or better logMAR distance visual acuity with manifest refraction in each eye and with +2.50-D add soft bifocal contact lenses on both eyes. Children were randomly assigned to wear Biofinity single-vision, Biofinity Multifocal "D" with a +1.50-D add power, or Biofinity Multifocal "D" with a +2.50-D add power contact lenses. RESULTS: We examined 443 subjects at the baseline visits, and 294 (66.4%) subjects were enrolled. Of the enrolled subjects, 177 (60.2%) were female, and 200 (68%) were white. The mean (± SD) age was 10.3 ± 1.2 years, and 117 (39.8%) of the eligible subjects were younger than 10 years. The mean spherical equivalent refractive error, measured by cycloplegic autorefraction was -2.39 ± 1.00 D. The best-corrected binocular logMAR visual acuity with glasses was +0.01 ± 0.06 (20/21) at distance and -0.03 ± 0.08 (20/18) at near. CONCLUSIONS: The BLINK study subjects are similar to patients who would routinely be eligible for myopia control in practice, so the results will provide clinical information about soft bifocal contact lens myopia control as well as information about the mechanism of the treatment effect, if one occurs.

Myopia Control: A Review.

Slowing the progression of myopia has become a considerable concern for parents of myopic children. At the same time, clinical science is rapidly advancing the knowledge about methods to slow myopia progression. This article reviews the peer-reviewed literature regarding several modalities attempting to control myopia progression. Several strategies have been shown to be ineffective for myopia control, including undercorrection of myopic refractive error, alignment fit gas-permeable contact lenses, outdoor time, and bifocal of multifocal spectacles. However, a recent randomized clinical trial fitted progressing myopic children with executive bifocals for 3 years and found a 39% slowing of myopia progression for bifocal-only spectacles and 50% treatment effect for bifocal spectacles with base-in prism, although there was not a significant difference in progression between the bifocal-only and bifocal plus prism groups. Interestingly, outdoor time has shown to be effective for reducing the onset of myopia but not for slowing the progression of myopic refractive error. More effective methods of myopia control include orthokeratology, soft bifocal contact lenses, and antimuscarinic agents. Orthokeratology and soft bifocal contact lenses are both thought to provide myopic blur to the retina, which acts as a putative cue to slow myopic eye growth. Each of these myopia control methods provides, on average, slightly less than 50% slowing of myopia progression. All studies have shown clinically meaningful slowing of myopia progression, including several randomized clinical trials. The most investigated antimuscarinic agents include pirenzepine and atropine. Pirenzepine slows myopia progression by approximately 40%, but it is not commercially available in the United States. Atropine provides the best myopia control, but the cycloplegic and mydriatic side effects render it a rarely prescribed myopia control agent in the United States. However, low-concentration atropine has been shown to provide effective myopia control with far fewer side effects than 1.0% atropine. Finally, two agents, low-concentration atropine and outdoor time have been shown to reduce the likelihood of myopia onset. Over the past few years, much has been learned about how to slow the progression of nearsightedness in children, but we still have a lot to learn.

Choroidal Thickness and Peripheral Myopic Defocus during Orthokeratology.

PURPOSE: To investigate whether significant thickening occurs in the human choroid in response to chronic peripheral myopic defocus during overnight orthokeratology. METHODS: Subjects were nine children 11 to 15 years old (mean [±SD] age, 13.61 [±1.25] years). Measurements were taken at baseline and after 1, 3, 6, and 9 months of successful orthokeratology. Choroidal thickness in central, superior, temporal, and nasal gazes were measured using the Zeiss Cirrus HD-OCT. The Lenstar LS 900 biometer provided a secondary measure of subfoveal choroidal thickness. Peripheral ocular length was measured in the same four fields of gaze with the Zeiss IOLMaster. Corneal and optical changes from orthokeratology were monitored throughout the study by corneal topography (Humphrey ATLAS), aberrometry (Complete Ophthalmic Analysis System), and central and peripheral autorefraction (Grand Seiko) after tropicamide 1% cycloplegia. RESULTS: All subjects had acceptable acuity and physiologic response to overnight wear. After 1 month, central refractive error (mean ± SD) became significantly less myopic (-2.25 ± 0.95 diopters [D] vs. -0.24 ± 1.03 D), keratometric values flattened by 1.6 D, the shape factor (Q) became more oblate (-0.28 ± 0.05 vs. +0.34 ± 0.41), and spherical aberration became more positive (+0.14 ± 0.08 µm vs. +0.46 ± 0.15 µm; all p = 0.008). Peripheral refractive error remained -1.0 to -3.5 D myopic in all fields of gaze throughout the study. There were no consistent, significant changes in choroidal thickness or ocular length at any retinal location during the study (all p > 0.051). Lenstar measurement of choroidal thickness was unsuccessful because of the absence of choroidal peaks associated with thicker choroids (rs = -0.66, p < 0.0001). CONCLUSIONS: The choroid did not show long-term thickening during orthokeratology despite the presence of substantial amounts of peripheral myopic defocus. Apparent inhibition of ocular growth was not attributed to an optical artifact of choroidal thickening, although smaller amounts of thickening or greater biological activity independent of thickening cannot be ruled out.

Peripheral optics with bifocal soft and corneal reshaping contact lenses.

PURPOSE: To determine whether bifocal soft contact lenses with a distance center design provide myopic defocus to the peripheral retina similar to corneal reshaping contact lenses. METHODS: Myopic subjects underwent five cycloplegic autorefraction readings centrally and at 10, 20, and 30 degrees temporally, nasally, superiorly, and inferiorly while wearing Proclear Multifocal "D" contact lenses with a +2.00-diopter add power (CooperVision, Fairport, NY) and after wearing Corneal Refractive Therapy (Paragon Vision Sciences, Mesa, AZ) contact lenses for 2 weeks. RESULTS: Fourteen subjects completed the study. Nine (64%) were female, and 12 (86%) were white. The average (± SD) spherical equivalent noncycloplegic manifest refraction for the right eye was -2.84 ± 1.29 diopters. The average logMAR best-corrected, binocular, high-contrast visual acuity was -0.17 ± 0.15 while wearing the bifocal soft contact lenses and -0.09 ± 0.16 after corneal reshaping contact lens wear (analysis of variance, p = 0.27). The orthokeratology contact lens yielded a more myopic peripheral optical profile than the soft bifocal contact lens at 20 and 30 degrees eccentricity (except inferior at 20 degrees); the two modalities were similar at 10 degrees eccentricity. CONCLUSIONS: Our data suggest that the two modalities are dissimilar despite the statistical similarities. The corneal reshaping contact lens shows an increase in relative peripheral myopic refraction, a pattern achieved by other studies, but the bifocal lens does not exhibit such a pattern. The low statistical power of the study could be a reason for lack of providing statistical difference in other positions of gaze, but the graphical representation of the data shows a marked difference in the peripheral optical profile between the two modalities. More sophisticated methods of measuring the peripheral optical profile may be necessary to accurately compare the two modalities and to determine the true optical effect of the bifocal soft contact lens on the peripheral retina.

Multifocal contact lens myopia control.

PURPOSE: Previous studies on soft multifocal contact lens myopia control published in the peer-reviewed literature reported findings of noncommercial contact lenses worn for 1 year or less. This study sought to determine the progression of myopia and axial elongation of children fitted with commercially available distance center soft multifocal contact lenses for 2 years. METHODS: Eight- to eleven-year-old children with -1.00 D to -6.00 D spherical component and less than 1.00 D astigmatism were fitted with soft multifocal contact lenses with a +2.00 D add (Proclear Multifocal "D"; CooperVision, Fairport, NY). They were age- and gender-matched to participants from a previous study who were fitted with single-vision contact lenses (1 Day Acuvue; Vistakon, Jacksonville, FL). A-scan ultrasound and cycloplegic autorefraction were performed at baseline, after 1 year, and after 2 years. Multilevel modeling was used to compare the rate of change of myopia and axial length between single-vision and soft multifocal contact lens wearers. RESULTS: Forty participants were fitted with soft multifocal contact lenses, and 13 did not contribute complete data (5 contributed 1 year of data). The adjusted mean ± standard error spherical equivalent progression of myopia at 2 years was -1.03 ± 0.06 D for the single-vision contact lens wearers and -0.51 ± 0.06 for the soft multifocal contact lens wearers (p < 0.0001). The adjusted mean axial elongation was 0.41 ± 0.03 and 0.29 ± 0.03 for the single-vision and soft multifocal contact lens wearers, respectively (p < 0.0016). CONCLUSIONS: Soft multifocal contact lens wear resulted in a 50% reduction in the progression of myopia and a 29% reduction in axial elongation during the 2-year treatment period compared to a historical control group. Results from this and other investigations indicate a need for a long-term randomized clinical trial to investigate the potential for soft multifocal contact lens myopia control.