Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Walline JJ

PROVIDER: S-EPMC5607949 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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

Walline Jeffrey J JJ Gaume Giannoni Amber A Sinnott Loraine T LT Chandler Moriah A MA Huang Juan J Mutti Donald O DO Jones-Jordan Lisa A LA Berntsen David A DA

Optometry and vision science : official publication of the American Academy of Optometry 20170901 9

<h4>Significance</h4>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.<h4>Purpose</h4>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 pro ...[more]

PMID: 28737608

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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.

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.

Project description:To 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. Multicenter, 6-month, randomized, controlled, double-masked clinical trial. One hundred ninety-nine myopic (-0.75 diopters [D] to -4.50 D) children aged 7 to 12 years. Participants 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. Axial elongation, change in SECAR. A 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. The 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.

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.

Project description: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.

Dataset Information

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

Publications

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

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