Efficacy and adverse reactions of peripheral add multifocal soft contact lenses in childhood myopia: a meta-analysis
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SUBMITTER: Song D
PROVIDER: S-EPMC11020872 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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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.
| S-EPMC5607949 | biostudies-literature
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.
| S-EPMC9072981 | biostudies-literature
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: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.
| S-EPMC8986568 | biostudies-literature
Project description:PurposeThere has been little research on myopia management options for patients with astigmatism. This study quantified changes in peripheral refraction induced by toric orthokeratology (TOK) and soft toric multifocal (STM) contact lenses.MethodsThirty adults with refractive error of plano to -5.00 D (sphere) and -1.25 to -3.50 D (cylinder) were enrolled. Cycloplegic autorefraction was measured centrally, ±20 degrees, and ±30 degrees from the line of sight nasally (N) and temporally (T) on the retina. Measurements were made at baseline, after 10 ± 2 days of TOK wear (without lenses on eye), and after 10 ± 2 days of STM wear (with lenses on the eyes) and compared with repeated-measures analysis of variance.ResultsCompared to baseline, TOK induced a myopic shift in defocus (M) at all locations (all P < 0.01), but STM only induced a myopic shift at 20 T in both eyes and 30 N/T in the left eye (all P < 0.01). TOK resulted in more myopic defocus than STM at all locations (all P < 0.05) except 20 T in the left eye. TOK induced more J0 astigmatism at all locations (all P < 0.02), except 20 N in the right eye; J0 with STM was different than baseline at 20 N in both eyes and 30 N in the right eye (all P < 0.02). TOK induced more J0 astigmatism than STM at all locations (all P < 0.01), except 20 T in the left eye. Differences in J45 astigmatism, when significant, were clinically small.ConclusionsGreater amounts of peripheral myopic defocus and J0 astigmatism were induced by TOK compared to STM, which may influence efficacy for myopia management.
| S-EPMC9287617 | biostudies-literature
Project description:PurposeTo compare the peripheral refraction and spherical aberration profiles along three visual field meridians of 16 commercial single vision (SV), bifocal (BF) and multifocal (MF) test contact lenses with a single vision control.MethodForty-four participants [24.2±2.4 years, SE: -0.50 to -4.50D] were randomly fitted, contra-laterally, with 6 SV's [Air Optix Aqua (control), Acuvue Oasys, Biofinity, Clariti, Night & Day and Proclear], 3 BF's [Acuvue Bifocal low and high add, MiSight] and 8 MF's [Proclear D & N in 1.5 and 2.5D adds; AirOptix, PureVision low & high adds]. Peripheral refraction was performed across horizontal, oblique and vertical meridians, with lenses on eye using the BHVI-EyeMapper. The power vectors M, J0, J45 and the spherical aberration coefficient were analysed. The peripheral refraction and aberration profiles of the test lenses were compared with the profiles of the control lens using curvature and slope coefficients.ResultsCompared to the control, a relative peripheral hyperopic shift (M), a less negative J0 curvature coefficient along the horizontal meridian, a less positive J0 curvature coefficient along the vertical meridian, a less negative J45 curvature coefficient along the oblique meridian and a more positive spherical aberration curvature coefficient along most meridians was seen with the Acuvue Bifocal and all center-near multifocal lenses. For the center-distance multifocal lenses the direction of the curvature coefficients of the same refraction and aberration components was opposite to that of the center-near lenses. The greatest differences in the slope coefficients when compared to the control were found for the Acuvue Bifocal lenses and all multifocal contact lenses for the refractive component M and the spherical aberration coefficient along the horizontal visual field meridian, with the Acuvue Bifocal and the center-near multifocal lenses having more positive coefficients and the center-distance lenses having more negative coefficients.ConclusionWhen worn on eye, different commercially available lens types produce differences in the direction and magnitude of the peripheral refraction and spherical aberration profiles along different visual field meridians. This information may be relevant to refractive development and myopia control.
| S-EPMC6951842 | biostudies-literature
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.
| S-EPMC7368986 | biostudies-literature
Project description:IntroductionTo evaluate the efficacy and safety of myopia control using a multifocal soft contact lens designed with high peripheral add power in schoolchildren.MethodsThis 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.ResultsFifty-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.ConclusionsTreatment 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.
| S-EPMC10787710 | biostudies-literature
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.
| S-EPMC5880703 | biostudies-literature