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

Walline, Jeffrey J.; Robboy, Marc; Hilmantel, Gene; Tarver, Michelle E.; Afshari, Natalie A.; Dhaliwal, Deepinder K.; Morse, Christie L.; Quinn, Christopher J.; Repka, Michael X.; Eydelman, Malvina B.

doi:10.1097/icl.0000000000000511

Cited by 35 publications

(34 citation statements)

References 43 publications

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“…This is in line with the recommendation of the Food and Drug Administration Public Workshop on Controlling the Progression of Myopia. 33 The lenses were matched for all parameters, with the exception of the dual-focus optical design of MiSight. This way, if physiological effects are produced in either a myopic or hyperopic direction, whatever the underlying etiology, they should be identical in the two groups, and thus, any refractive and axial length differences between the two groups can be attributed to the optical design.…”

Section: Discussionmentioning

confidence: 99%

A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control

Chamberlain¹,

et al. 2019

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SIGNIFICANCE: Results of this randomized, double-masked clinical trial demonstrate the effectiveness of the MiSight soft contact lens in slowing myopia progression over multiple years. PURPOSE: The purpose of this study was to quantify the effectiveness of MiSight daily disposable soft contact lens in slowing the progression of juvenile-onset myopia. METHODS: Myopic children (spherical equivalent refraction, −0.75 to −4.00 D; astigmatism, <1.00 D) aged 8 to 12 years with no prior contact lens experience were enrolled in a 3-year, double-masked, randomized clinical trial at four investigational sites in four countries. Subjects in each group were matched for age, sex, and ethnicity and were randomized to either a MiSight 1-day contact lens (test) or Proclear 1-day (control; omafilcon A) and worn on a daily disposable basis. Primary outcome measures were the change in cycloplegic spherical equivalent refraction and axial length. RESULTS: Of the subjects enrolled, 75.5% (109/144) completed the clinical trial (53 test, 56 control). Unadjusted change in spherical equivalent refraction was −0.73 D (59%) less in the test group than in the control group (−0.51 ± 0.64 vs.-1.24 ± 0.61 D, P < .001). Mean change in axial length was 0.32 mm (52%) less in the test group than in the control group (0.30 ± 0.27 vs. 0.62 ± 0.30 mm, P < .001). Changes in spherical equivalent refraction and axial length were highly correlated (r = −0.90, P < .001). Over the course of the study, there were no cases of serious ocular adverse events reported. Four asymptomatic corneal infiltrative (one test, three control) events were observed at scheduled study visits. CONCLUSIONS: Results of this clinical trial demonstrate the effectiveness of the MiSight daily disposable soft contact lens in slowing change in spherical equivalent refraction and axial length.

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Section: Discussionmentioning

confidence: 99%

A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control

Chamberlain¹,

et al. 2019

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“…The magnitude of the annual reduction in SER ranged from 0.13 to 0.17 D, which is consistent with a reduction of 0.03 to 0.08 mm change in AL. A consensus workshop, Controlling the Progression of Myopia, sponsored by the United States Food and Drug Administration (FDA) and attended by experts in myopia from several professional organisations, concluded that a minimum difference in refractive error of 0.75 D between the treatment groups would be considered clinically significant over a period of 3 years (change of 0.25 D annually) 55 …”

Section: Discussionmentioning

confidence: 99%

Time spent outdoors as an intervention for myopia prevention and control in children: an overview of systematic reviews

Dhakal

Shah

Huntjens

et al. 2022

Ophthalmic Physiologic Optic

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Purpose: Outdoor light exposure is considered a safe and effective strategy to reduce myopia development and aligns with existing public health initiatives to promote healthier lifestyles in children. However, it is unclear whether this strategy reduces myopia progression in eyes that are already myopic. This study aims to conduct an overview of systematic reviews (SRs) reporting time spent outdoors as a strategy to prevent myopia or slow its progression in children. Methods:We searched the Cochrane Library, EMBASE, MEDLINE and CINAHL from inception to 1 November 2020 to identify SRs that evaluated the association between outdoor light exposure and myopia development or progression in children. Outcomes included incident myopia, prevalent myopia and change in spherical equivalent refraction (SER) and axial length (AL) to evaluate annual rates of myopia progression. The methodological quality and risk of bias of included SRs were assessed using the AMSTAR-2 and ROBIS tools, respectively.Results: Seven SRs were identified, which included data from 47 primary studies with 63,920 participants. Pooled estimates (risk or odds ratios) consistently demonstrated that time outdoors was associated with a reduction in prevalence and incidence of myopia. In terms of slowing progression in eyes that were already myopic, the reported annual reductions in SER and AL from baseline were small (0.13-0.17 D) and regarded as clinically insignificant. Methodological quality assessment using AMSTAR-2 found that all reviews had one or more critical flaws and the ROBIS tool identified a low risk of bias in only two of the included SRs. Conclusion:This overview found that increased exposure to outdoor light reduces myopia development. However, based on annual change in SER and AL, there is insufficient evidence for a clinically significant effect on myopia progression. The poor methodological quality and inconsistent reporting of the included systematic reviews reduce confidence in the estimates of effect.

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“…This event was the first of its kind to bring together interdisciplinary bodies that all see value in adopting MC practices and, to date, has seen the publication of two papers describing the meeting. 177,178 These are just a few examples of how the global increase in myopia prevalence and rates of myopia progression in the youngest patient population has caught the attention of global health agencies. The response of these agencies to supply public information, much of which resides on the internet and is not evidence-based, puts the onus on academics to ensure that accurate information is provided to both clinicians and the public.…”

Section: Imi -Industry Guidelines For Myopia Control Studiesmentioning

confidence: 99%

“…176 Two papers have been published in relation to this meeting, one reviewing previous key studies and a second discussing study design and regulatory issues relevant to future clinical trials. 177,178 Further discussion of experimental design considerations is presented in the accompanying IMI -Clinical Myopia Control Trials and Instrumentation Report. 144 For both drugs and devices, regulatory bodies may impose post-approval requirements, such as postmarket surveillance.…”

Section: Product Registrationmentioning

confidence: 99%