Pilot Study to Assess the Efficacy of Short Exposure to Defocus to Slow the Progression of Myopia in Children
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The objective of this pilot study is to establish whether brief periods of high levels of acutely imposed myopic defocus can be used to slow the progression of myopia in children, as measured by changes in spherical equivalent refraction and axial length.
Condition or disease
Device: Hyperopic lens
Recent results on animal models of myopia suggest that the eye has the ability to detect the overall sign of defocus of images falling on the retina, with myopic defocus imposed by the fitting of plus-lenses halting or slowing axial elongation of the eye. In the animal models, these STOP growth signals have been shown to be particularly strong - with brief periods of high myopic defocus able to outweigh the effects of prolonged periods of imposed hyperopic defocus in promoting eye growth. These results therefore suggest a novel strategy for preventing the progression of myopia in children - the imposition of high levels of myopia for brief periods of time. This approach is conceptually distinct from under-correction, which imposes chronic mild myopic defocus.
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Ages Eligible for Study:
6 Years to 12 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Children aged 6 to 12 years
Refractive error of spherical equivalent -1.00 D to -6.00D in each eye as measured by cycloplegic autorefraction
Active myopia progression of at least spherical equivalent -0.50 D over the last 12 months as determined or suggested by refractive records or change in lens power
Astigmatism of less than or equal to -1.50 D as measured by non-cycloplegic or cycloplegic autorefraction
Distance vision correctable to logMAR 0.1 or better in both eyes
Normal intraocular pressure of not greater than 21 mmHg
Normal ocular health other than myopia
In good general health
Willing and able to comply with scheduled visits and other study procedures
Baseline Anisometropia of > 1.5D
Ocular or systemic diseases which may affect vision or refractive error
Defective binocular function or stereopsis
Amblyopia or manifest strabismus including intermittent tropia
Previous or current use of atropine or pirenzepine
Any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study
Allergy to cyclopentolate, proparacaine and benzalkonium chloride