An interventional study of Spectacles in Myopia, sponsored by Brien Holden Vision Institute. Status unknown at 1 site in Vietnam. Open to participants aged 7 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-07.
Sponsored by Brien Holden Vision Institute · Not applicable, Interventional, and Treatment
Myopia, considered as a global epidemic, is rapidly rising in prevalence especially in east Asian countries. Younger ages are associated with greater annual progression and thus early onset myopia is likely to result in higher levels of final net myopia.[1] Myopia, especially high myopia (more than -6.00D) is associated vision threatening complications such as cataract, glaucoma, choroidal thinning, vitreous liquefaction, myopic maculopathy, retinal detachment etc. Furthermore, myopia can affect the quality of life of an individual through restriction of employment in certain fields such as aviation. Myopia also imposes economic burden through the recurring cost of vision correction such as spectacles, contact lenses and specialist consultation fee. It is therefore important to develop novel optical and pharmaceutical strategies that can control or slow the progression of myopia.
To date, the strategies used to control or slow the progression of myopia are optical and pharmaceutical methods. Among spectacles, bifocal spectacles with and without prism, progressive addition lenses, spectacles altering peripheral hyperopic defocus, spectacles imposing myopic defocus both centrally and peripherally and spectacles with multiple defocus segments that imposes myopic defocus in front, midperiphery and periphery of the retina (defocus incorporating multiple segments or DIMS) are used to reduce the progression[2-6]. Of these, spectacles designed to alter peripheral defocus demonstrated a small treatment effect in reducing myopia progression[6, 7]. Bifocal and progressive addition spectacles demonstrated variable treatment effect in reducing progression of myopia. Among contact lenses, multifocal contact lenses altering peripheral defocus, extended depth of focus contact lenses altering higher order aberrations in order to degrade the retinal image behind the retina have shown promising results in slowing myopia progression along with orthokeratology treatment[8-12]. Among these, orthokeratology and multifocal soft contact lenses (centre distance multifocal contact lenses) showed promising results in slowing myopia progression[9, 12].
Pharmaceutical interventions include Atropine, Pirenzepine, 7-Methylxanthine and Timolol[13].Atropine is the most widely used, with higher concentrations more effective. Atropine 1% concentration demonstrated 60 to 80% reduction in progression of myopia. However, ocular side effects such as blurred vision, photophobia etc associated with atropine makes it a less appealing option. Among the various treatment approaches, spectacles pose the least or minimal side effects compared to contact lenses, orthokeratology or pharmaceutical strategies. Therefore, this study aims to determine the effect of novel myopia control prototype spectacle design on wearability and physiological ocular response among myopic children aged 7 to 14 years.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Brien Holden Vision Institute is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Commercially available conventional single vision spectacles
Device: Spectacles
Commercially available myopia control spectacles
Device: Spectacles
Experimental myopia control spectacles
Device: Spectacles
Experimental myopia control spectacles
Device: Spectacles
Novel spectacles for myopia control
Change in axial length
Change in axial length measured using Lenstar
Time frame: one monthly interval for up to 6 months
Vision and Choroidal Physiology
Vision and Choroidal Physiology determined using standard vision charts and Optical Coherence Tomography (OCT)
Time frame: One monthly interval for up to 6 months
Plan to share: No
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This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Brien Holden Vision Institute