MiSight Assessment Study Spain (MASS). A 2-year randomized clinical trial

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155

PurposeWe aimed to determine myopia control efficacy with novel contact lenses (CL) that (1) reduced both central and peripheral defocus, and (2) provided extended depth of focus with better global retinal image quality for points on, and anterior to, the retina and degraded for points posterior to the retina.MethodsChildren (n = 508, 8–13 years) with cycloplegic spherical equivalent (SE) −0.75 to −3.50D were enrolled in a prospective, double blind trial and randomised to one of five groups: (1) single vision, silicone hydrogel (SH) CL; (2) two groups wearing SH CL that imposed myopic defocus across peripheral and central retina (test CL I and II; +1.00D centrally and +2.50 and +1.50 for CL I and II at 3 mm semi‐chord respectively); and (3) two groups wearing extended depth of focus (EDOF) hydrogel CL incorporating higher order aberrations to modulate retinal image quality (test CL III and IV; extended depth of focus of up to +1.75D and +2.50D respectively). Cycloplegic autorefraction and axial length (AL) measurements were conducted at six monthly intervals. Compliance to lens wear was assessed with a diary and collected at each visit. Additionally, subjective responses to various aspects of lens wear were assessed. The trial commenced in February 2014 and was terminated in January 2017 due to site closure. Myopia progression over time between groups was compared using linear mixed models and where needed post hoc analysis with Bonferroni corrections conducted.ResultsMyopia progressed with control CL −1.12 ± 0.51D/0.58 ± 0.27 mm for SE/AL at 24 months. In comparison, all test CL had reduced progression with SE/AL ranging from −0.78D to −0.87D/0.41–0.46 mm at 24 months (AL: p < 0.05 for all test CL; SE p < 0.05 for test CL III and IV) and represented a reduction in axial length elongation of about 22% to 32% and reduction in spherical equivalent of 24% to 32%. With test CL, a greater slowing ranging from 26% to 43% was observed in compliant wearers (≥6 days per week; Control CL: −0.64D/0.30 mm and −1.14D/0.58 mm vs test CL: −0.42D to −0.47D/0.12–0.18 mm and −0.70 to −0.81D/0.19–0.25 mm at 12 and 24 months respectively).ConclusionsContact lenses that either imposed myopic defocus at the retina or modulated retinal image quality resulted in a slower progression of myopia with greater efficacy seen in compliant wearers. Importantly, there was no difference in the myopia control provided by either of these strategies.

Section: Discussionmentioning

confidence: 56%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Myopia control with novel central and peripheral plus contact lenses and extended depth of focus contact lenses: 2 year results from a randomised clinical trial

Sankaridurg

Bakaraju

Naduvilath

et al. 2019

122

155

“…Specifically, myopia control has been attempted with commercially available simultaneous‐vision bifocal/multifocal soft contact lenses, as well as lenses with novel dedicated myopia control designs. Almost all of these soft contact lenses extend the depth of focus of the eye . If children under‐accommodate by utilising the more proximal retinal conjugate plane created by the “add” power of the lens, the “distance” optics will create significant hyperopic defocus, which may diminish or eliminate the myopia control effect of the lens.…”

Section: Introductionmentioning

confidence: 99%

Accommodation and its role in myopia progression and control with soft contact lenses

Cheng

Brennan

2019

Purpose To examine the impact of contact lens optical design on accommodative behaviour of children and the correlation between myopia progression and the accommodative response of the eye while wearing a contact lens designed for myopia control. Methods A post‐hoc analysis was conducted on data from a previously published myopia control trial. A total of 109 subjects (aged 8 to 11 years, myopia: −0.75 to −4.00 D) wore either a Control (single‐vision, n = 57) or a Test (with positive spherical aberration, +SA, n = 52) soft contact lens, binocularly for 1 year. Accommodative response was measured as the subject observed targets at −1.00 to −4.00 D vergence using the Grand Seiko WAM‐5500 open‐field autorefractor (http://www.grandseiko.com). Slope of accommodative response (SAR) as well as distance and near phoria and stimulus accommodative convergence/accommodation (AC/A) were compared between each group at baseline without study lenses and at 1‐week and 1‐year visits with study lenses. The SAR was also compared to changes in axial length (AL) and spherical equivalent cycloplegic auto refraction (SECAR). Results At baseline, there was no significant difference in SAR between the two study groups (ΔSAR = −0.039, p = 0.84). At 1 week, mean SAR of the Test group was significantly less than for the Control group (ΔSAR = −0.203, p < 0.0001), an effect that persisted to 1 year (ΔSAR = −0.129, p < 0.0001). In the Test group, greater SAR was associated with less change in AL (regression coefficient: −0.59 mm, p < 0.0001) and SECAR (regression coefficient: 1.12 D, p = 0.006) at 1 year. In the Control group, associations between SAR and change in AL and SECAR were not statistically significant. Compared to the Control group, eyes of the Test group appeared to be more exophoric with study lenses, however, the difference between the two groups was only significant at 1 week for distance phoria and 1 year for near phoria. Conclusion The soft contact lens with +SA for controlling myopia progression resulted in an apparent decrease in mean accommodation. Within the Test group, reduced accommodative response correlated with greater myopia progression, suggesting some subjects in the Test group utilised the +SA for near viewing, inducing hyperopic defocus at the retina. Accordingly, the potential impact of a lens optics on accommodative function should be considered during design of myopia control lenses.

“…Between 2011 and 2019, 9 randomised trials with soft dual focus contact lenses were published . Four studies used lenses with a concentric design; the other studies used lenses with a progressive design.…”

Section: Myopia Managementmentioning

confidence: 99%

Myopia management in the Netherlands

Klaver

Polling

2020

Purpose A trend that myopia is becoming gradually more common is shown in studies worldwide. Highest frequencies have been found in East Asian urban populations (96.5%) but also a study in Europe shows that nearly half of the 25‐29 year olds has myopia. With the increase in prevalence, high myopia, i.e. a spherical equivalent of ‐6 or more and an axial length of 26 mm or more is also on the rise. High myopia particularly carries a significant risk of ocular pathology related to the long axial length. This highlights the need for myopia management in children with progressive myopia, in particular progression to high myopia. Recent findings During the last decade, many intervention studies for myopia progression have emerged. Although lifestyle adjustments are effective, pharmacological and optical interventions have shown the highest efficacy on reduction of eye growth. High concentration atropine (0.5%‐1.0%) shows the most reduction in axial length progression, but has drawbacks of light sensitivity and loss of accommodation. Nevertheless, when these side effects are mitigated by multifocal photochromatic glasses, the long‐term adherence to high dose atropine is high. Lower concentrations of atropine are less effective, but have less side effects. Studies on optical interventions have reported reduction of progression for Ortho‐K and multifocal contact lenses, but are in need for replication in larger studies with longer duration. Summary The field of myopia management is rapidly evolving, and a position on the best approach for daily clinics is desirable. Over the last 10 years, our team of clinical researchers has developed a strategy which involves decision‐making based on age, axial length, position on the axial length growth chart, progression rate, risk of high myopia, risk profile based on lifestyle and familial risk, side effects, and individual preference. This personalised approach ensures the most optimal long‐term myopia control, and helps fight against visual impairment and blindness in the next generations of elderly.