None listed
Conditions
Brief summary
The aim of the study is to determine whether a combined therapy of atropine eye drops together with myopic retinal defocus delivered simultaneously with an ophthalmic lens to the retina of a myopic child will slow myopia progression more effectively than either therapy alone. Both atropine and myopic defocus independently cause thickening of the human choroid. This study investigates whether the choroidal thickening produced by simultaneous presentation of myopic defocus and atropine is greater than the thickness changes induced by each technique alone. A finding of superposition (summation of effects) would imply that the efficacy of myopia control based on imposing myopic defocus to the retina could be increased by simultaneous administration of atropine.
Interventions
Intervention 1: Atropine eye drops. Concentration 0.3%; one drop administered to the participant by the parent/caregiver to each eye, every night before sleep, for 6 months.
Intervention 2: Optical defocus to the retina of one (experimental) eye for periods of 60 minutes. Experimental eye pseudorandomly assigned: remains the same throughout the study. Degree of defocus +2.00 and -2.00 dioptres applied to experimental eye on two successive days; defocus applied with ophthalmic lenses. Administer
Intervention 1: Atropine eye drops. Concentration 0.3%; one drop administered to the participant by the parent/caregiver to each eye, every night before sleep, for 6 months. Intervention 2: Optical defocus to the retina of one (experimental) eye for periods of 60 minutes. Experimental eye pseudorandomly assigned: remains the same throughout the study. Degree of defocus +2.00 and -2.00 dioptres applied to experimental eye on two successive days; defocus applied with ophthalmic lenses. Administered by research optometrist before initiating atropine treatment, then (over two successive days only) at one week, 3 months and 6 months during atropine treatment. Compliance to intervention 1 assessed by questionnaire to parent at each visit. Intervention 2 administered directly by research optometrist in clinic.
Sponsors
The University of Auckland
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
Spherical Equivalent Refractive error (myopia) between -0.75 D and -4.50 D and visual acuity of at least 0.0 logMAR.
Exclusion criteria
Children with any known ocular pathology, astigmatism in either eye greater than -1.00 DC, anisometropia greater than 1.00 D, or a history of pharmacological myopia control.
Outcome results
None listed