Efficacy of Multifocal Soft Contact Lenses in Reducing Myopia Progression Among Taiwanese Schoolchildren: A Randomized Paired-Eye Clinical Trial.
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ABSTRACT: Introduction
To evaluate the efficacy and safety of myopia control using a multifocal soft contact lens designed with high peripheral add power in schoolchildren.Methods
This 1-year multi-center, prospective, randomized, double-blind, controlled study enrolled myopic schoolchildren aged 6-15 years with refractive errors between - 1.0 D and - 10.0 D. Each participant was randomly allocated to wear a daily disposable multifocal soft contact lens as the treatment in one eye and a single-vision soft contact lens as the control in the other eye. The primary endpoints were changes in the cycloplegic spherical equivalent (SE) and axial length at 1 year.Results
Fifty-two of the 59 participants (88.1%) completed the study protocol. The mean change in SE was - 0.73 ± 0.40 D in the treatment group. and - 0.85 ± 0.51 D in the control group (mean difference: - 0.12 ± 0.34 D, p = 0.012). The mean change in axial length was 0.25 ± 0.14 mm in the treatment group, and 0.33 ± 0.17 mm in the control group (mean difference: 0.08 ± 0.10 mm, p < 0.001). The treatment was well tolerated, and no serious adverse events were observed.Conclusions
Treatment with multifocal soft contact lenses with high peripheral add power was effective in controlling the progression of myopia and axial length elongation in myopic schoolchildren.
SUBMITTER: Liu YL
PROVIDER: S-EPMC10787710 | biostudies-literature | 2024 Feb
REPOSITORIES: biostudies-literature
Publications
Efficacy of Multifocal Soft Contact Lenses in Reducing Myopia Progression Among Taiwanese Schoolchildren: A Randomized Paired-Eye Clinical Trial.
Liu Yao-Lin YL Lin Ken-Kuo KK Cheng Li-Sheng LS Lin Chao-Wen CW Lee Jiahn-Shing JS Hou Chiun-Ho CH Tsai Tzu-Hsun TH
Ophthalmology and therapy 20231221 2
<h4>Introduction</h4>To evaluate the efficacy and safety of myopia control using a multifocal soft contact lens designed with high peripheral add power in schoolchildren.<h4>Methods</h4>This 1-year multi-center, prospective, randomized, double-blind, controlled study enrolled myopic schoolchildren aged 6-15 years with refractive errors between - 1.0 D and - 10.0 D. Each participant was randomly allocated to wear a daily disposable multifocal soft contact lens as the treatment in one eye and a si ...[more]
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Project description:SignificanceThe 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.PurposeThe 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.MethodsSubjects 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.ResultsWe 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.ConclusionsThe 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.
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Project description:SignificanceCombining 0.01% atropine with soft multifocal contact lenses (SMCLs) failed to demonstrate better myopia control than SMCLs alone.PurposeThe 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.MethodsParticipants 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.ResultsOf 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.ConclusionsAdding 0.01% atropine to SMCLs with +2.50-D add power failed to demonstrate better myopia control than SMCLs alone.
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Project description:Bifocal and multifocal optical devices are intended to get images into focus from objects placed at different distances from the observer. Spectacles, contact lenses, and intraocular lenses can meet the requirements to provide such a solution. Contact lenses provide unique characteristics as a platform for implementing bifocality and multifocality. Compared to spectacles, they are closer to the eye, providing a wider field of view, less distortion, and their use is more consistent as they are not so easily removed along the day. In addition, contact lenses are also minimally invasive, can be easily exchangeable, and, therefore, suitable for conditions in which surgical procedures are not indicated. Contact lenses can remain centered with the eye despite eye movements, providing the possibility for simultaneous imaging from different object distances. The main current indications for bifocal and multifocal contact lenses include presbyopia correction in adult population and myopia control in children. Considering the large numbers of potential candidates for optical correction of presbyopia and the demographic trends in myopia, the potential impact of contact lenses for presbyopia and myopia applications is undoubtedly tremendous. However, the ocular characteristics and expectations vary significantly between young and older candidates and impose different challenges in fitting bifocal and multifocal contact lenses for the correction of presbyopia and myopia control. This review presents the recent developments in material platforms, optical designs, simulated visual performance, and the clinical performance assessment of bifocal and multifocal contact lenses for presbyopia correction and/or myopia progression control.
| S-EPMC7152962 | biostudies-literature
Project description: Not available
| S-EPMC11020872 | biostudies-literature
Project description:SignificanceThe contrast sensitivity (CS) function provides a more detailed assessment of vision than visual acuity. It was found that center-distance multifocal contact lens designs that are increasingly being prescribed for myopia control reduce distance photopic and mesopic CS in nonpresbyopic patients across a range of spatial frequencies.PurposeThis study aimed to determine the effect of center-distance multifocal soft contact lenses (MFCLs) on CS under photopic and mesopic conditions in nonpresbyopic patients.MethodsTwenty-five myopic, nonpresbyopic adults were fitted binocularly with three lenses: Biofinity single vision contact lens (SVCL), Biofinity Multifocal D +2.50 add, and NaturalVue Multifocal in random order. Contrast sensitivity was measured at distance (4 m) under photopic and mesopic conditions and at near under photopic conditions. Log CS by spatial frequency and area under the log contrast sensitivity function (AULCSF) were analyzed between lenses.ResultsDistance photopic CS at each spatial frequency was higher with the SVCL than the MFCLs (P < .001), but there was no difference between the MFCLs (P = .71). Distance mesopic CS from 1.5 to 12 cycles per degree (cpd) was higher with the SVCL than the MFCLs (all P < .02); however, at 18 cpd, there was no difference in CS between NaturalVue and the SVCL (P = .76), possibly because of spurious resolution. Photopic AULCSF for the SVCL was roughly 10% greater than both MFCLs. Contrast sensitivity at near was generally similar between lenses, only slightly lower with the NaturalVue at 11 and 15.5 cpd, but AULCSF at near was not different between lenses (P > .05).ConclusionsMultifocal contact lenses reduce distance contrast sensitivity under both photopic and mesopic conditions. There is no clinically significant difference in near CS among all three lenses. These data show that MFCLs have effects on vision that are not captured by standard high-contrast visual acuity testing.
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Project description:Background:It is unclear whether multifocal soft contact lenses (MFSCLs) affect visual quality when they are used for myopia control in juvenile myopes. The aim of this study was, therefore, to investigate the effect of MFSCLs on visual quality among juvenile myopia subjects. Methods:In a prospective, intervention study, thirty-three juvenile myopes were enrolled. Visual perception was assessed by a quality of vision (QoV) questionnaire with spectacles at baseline and after 1 month of MFSCL wear. At the one-month visit, the high (96%) contrast distance visual acuity (distance HCVA) and low (10%) contrast distance visual acuity (distance LCVA) were measured with single vision spectacle lenses, single vision soft contact lenses (SVSCLs) and MFSCLs in a random order. Wavefront aberrations were measured with SVSCLs, with MFSCLs, and without any correction. Results:Neither distance HCVA (p?>?0.05) nor distance LCVA (p?>?0.05) revealed any significant difference between MFSCLs, SVSCLs and single vision spectacle lenses. The overall score (the sum of ten symptoms) of the QoV questionnaire did not show a statistically significant difference between spectacles at baseline and after 1 month of MFSCL wear (p?=?0.357). The results showed that the frequency (p?<?0.001), severity (p?=?0.001) and bothersome degree (p?=?0.016) of halos were significantly worse when wearing MFSCLs than when wearing single vision spectacle lenses. In contrast, the bothersome degree caused by focusing difficulty (p?=?0.046) and the frequency of difficulty in judging distance or depth perception (p?=?0.046) were better when wearing MFSCLs than when wearing single vision spectacle lenses. Compared with the naked eye, MFSCLs increased the total aberrations (p?<?0.001), higher-order aberrations (p?<?0.001), trefoil (p?=?0.023), coma aberrations (p?<?0.001) and spherical aberrations (SA) (p?<?0.001). Compared with the SVSCLs, MFSCLs increased the total aberrations (p?<?0.001), higher-order aberrations (p?<?0.001), coma aberrations (p?<?0.001) and SA (p?<?0.001). The direction of SA was more positive (p?<?0.001) with the MFSCLs and more negative (p?=?0.001) with the SVSCLs compared with the naked eye. Conclusions:Wearing MFSCLs can provide satisfactory corrected visual acuity (both distance HCVA and distance LCVA). Although the lenses increased the aberrations, such as total aberrations and higher-order aberrations, there were few adverse effects on the distance HCVA, distance LCVA and visual perception after 1 month of MFSCL use. Trial registration:Chinese Clinical Trial Registry: ChiCTR-OOC-17012103. Registered 23 July 2017, http://www.chictr.org.cn/usercenter.aspx.
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Project description:PurposeTo evaluate the impact of soft contact lens eye-fit on optical power by computational modelling and to produce correction maps for reversing this impact during the design process.MethodsFinite element models of spherical and toric hydrogel contact lenses at varying nominal powers of -20 D to +20 D, base curves radii (R1b) of 8.2, 8.5, 8.8 mm, and overall diameters (d3) of 14.5, 15.0, 15.5 mm were generated. Lenses were fitted to computational eye models generated with human eyes' topography data. Combined eye-lens simulations were run under the boundary conditions of the tears' surface tension between the contact lens and the eye in addition to the eyelid blink pressure. Lens optical zone power changes were calculated through computational light-ray tracing methods following each simulation.ResultsEffective power changes (EPC) were affected negatively for all toric simulated lenses with power varying from -20 D to +20 D. Spherical lenses demonstrated similar behaviour, however with some positive EPC over the power range from -20 D to -10 D for spherical power (SPH) lenses. EPC assessment was between +0.25 D and -0.5 D for most lenses, however, lenses with prescriptions from +10 D to +20 D incurred EPC outside this range. The spherical lenses showed a maximum effective power change of +1.046 ± 0.338 D (Average Eye), and a minimum of -3.278 ± 0.731 D (Steep Eye). Similarly, the toric lenses showed a maximum of +1.501 ± 0.338 D (Average Eye), and a minimum of -3.514 ± 0.731 D (Steep Eye). EPC trends, along with minimum and maximum power, generally increased negatively as nominal lens prescription increased positively. Contact lens base curve selection affected the assessed effective power change for both spherical and toric lenses. The effect from lens total diameter for spherical lenses was less substantial than that for toric lenses.ConclusionsThis study considered the impact of soft contact lens design parameters on effective optical power changes (EPC) after eye-fit. Spherical lenses experienced more EPC of clinical significance (>0.25 D) than toric lenses. Both types of lenses, spherical and toric (simple astigmatism), demonstrated similar trends in EPC on fitting from -20 D to +20 D, with lenses in the extremely positive and the extremely negative prescriptions demonstrating the highest EPCs. The lens base curve impacted the extent of EPC observed, with flatter base curves experiencing less power change. Diameter proved to impact toric lenses more than spherical ones, however generally the diameter has less effect on power change than base curve selection.
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Project description:PurposeTo compare the visual performance of soft contact lenses reported to reduce myopia progression.MethodsIn 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.ResultsProclear 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.ConclusionsThe prototypes were better tolerated by myopes compared to the commercial soft contact lenses currently used for slowing myopia progression.
| S-EPMC6181805 | biostudies-literature
Project description:SignificancePractitioners 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).PurposeTo determine the spherical over-refraction (SOR) necessary to obtain best-corrected visual acuity (BCVA) when fitting myopic children with a center-distance soft MFCL.MethodsChildren (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.ResultsThe 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).ConclusionsChildren 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.
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Project description:PurposeTo evaluate efficacy and vision with 2 prototype myopia control soft contact lenses with noncoaxial ring-focus designs (for enhancing efficacy [EE] and enhancing vision [EV]) compared with dual-focus (DF) and single-vision (SV) designs.DesignMulticenter, 6-month, randomized, controlled, double-masked clinical trial.ParticipantsOne hundred ninety-nine myopic (-0.75 diopters [D] to -4.50 D) children aged 7 to 12 years.MethodsParticipants were randomized with stratification into myopia control (EE, EV, or DF) or SV arms at 9 clinical sites in 3 countries. Postcycloplegia axial length (AL) and spherical equivalent autorefraction (SECAR) were measured at baseline and 26 weeks. Axial length was also measured without cycloplegia at baseline, 1, 4, 13, and 26 weeks. Progression was analyzed using linear mixed models by intention-to-treat population. Visual acuity (VA) and vision quality were monitored.Main outcome measuresAxial elongation, change in SECAR.ResultsA total of 185 subjects completed the study (n = 44, 49, 45, and 47 for EE, EV, DF, and SV, respectively). There were no serious/significant ocular adverse events. After 26 weeks, EE, EV, and DF all had statistically significantly less axial elongation than SV (unadjusted mean [standard deviation]: EE, 0.079 [0.125]; EV, 0.119 [0.101]; DF, 0.135 [0.117]; SV; 0.189 [0.121] mm). The estimated least-square mean (LSM) differences (adjusted 95% confidence interval) compared with SV were -0.105 (-0.149, -0.062), -0.063 (-0.106, -0.020), and -0.056 (-0.100, -0.013) mm for EE, EV, and DF, respectively. Enhancing efficacy alone had statistically significantly less progression of SECAR than SV (EE: -0.12 [0.27] D vs. SV: -0.35 [0.33] D; LSM difference: 0.22 D [0.09, 0.35]). Enhancing efficacy also had statistically significantly less axial elongation than DF (-0.049 mm [-0.093, -0.004]). Changes in AL and SECAR of EV and DF were not statistically different. All 3 myopia control lenses had mean VA close to 0.00 logarithm of the minimum angle of resolution (logMAR) with estimated 95% upper confidence limits <0.10 logMAR. Enhancing efficacy and DF produced similar reports of halos but more than EV and SV.ConclusionsThe prototype contact lenses met the design intent; EE was more efficacious in slowing axial elongation than DF with comparable vision performance, whereas EV produced comparable efficacy to DF with similar vision performance to SV.
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