Effect of low dose atropine eye drops on eye-related changes at near focal distances in children and young adults
Effect of low dose atropine eye drops on ocular changes during accommodation in children and young adults with myopia
Queensland University of Technology
30 participants
Jul 16, 2021
Interventional
Conditions
Summary
Low dose atropine eye drops (in varying concentrations from 0.01% to 0.1% ) are a treatment strategy that has shown promise to slow or halt myopia (short-sightedness) progression in children in a dose-dependent manner, with a minimum concentration of 0.025% has been recommended for use in children as a balance between efficacy and the side effect profile. Recent studies have demonstrated that there is an increase in eye length (distance from the cornea to retina) and higher order aberrations (HOA’s; optical imperfections which degrade the image quality of the eye), and a decrease in retinal image quality when children focus their eyes at close distances. Atropine is known to reduce the focusing ability of the eye, however the effect of low dose atropine on changes in eye length, HOA's, and image quality during near focus in myopic children remains unknown and it is possible that atropine alters these changes, which may contribute to its effect in slowing myopia progression. The primary objective of this project is to examine the effect of nightly dosing of 0.025 atropine sulfate eye drops for approximately 7 nights on the changes in eye length, HOA's, focal power, pupil diameter, and image quality in myopic children during near focusing. This research is expected to provide greater understanding of the effect of low dose atropine on the focusing mechanism of the eye and associated eye changes, in addition to the potential mechanisms underpinning the myopia control effect of low dose atropine eye drops.
Eligibility
Inclusion Criteria1
- Healthy myopic children, adolescents, and young adults aged 6 to 25 years and with a myopic refractive error between -0.50 and -5.00 DS, and no greater than 1.00 D of astigmatism or anisometropia. Participants will currently be corrected with spectacles or contact lenses.
Exclusion Criteria12
- Current or previous use of myopia control treatments (atropine, OrthoK, peripheral defocus soft contact lenses or spectacle lenses)
- Amblyopia or strabismus
- Stereopsis of 200 seconds of arc or greater
- Monocular amplitude of accommodation of less than 8 D
- Best corrected visual acuity (BCVA) poorer than 0.1 logMAR in both eyes, or greater than 1 line (0.1 logMAR) difference in VA between eyes
- History of ocular surgery
- History of significant ocular infection or injury
- Known allergy to atropine, tropicamide, or benzalkonium chloride (BAK)
- Known angle closure glaucoma, or temporal VH ratio <0.3:1 in either eye
- Intraocular pressure greater than 21 mmHg in either eye
- Current use of: anticholinergics, antiglaucoma medications, antimyasthenics, potassium drugs, carbachol/physostigmine/pilocarpine, no CNS depressants (such as antiemetics, phenothiazines, or barbiturates).
- History of Down's syndrome, spastic paralysis, or brain damage.
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Interventions
Participants will receive 0.025% atropine sulphate eye drops (preserved with 0.1% benzalkonium chloride), taken as one drop in each eye, once daily (at night before sleep), for a duration of 7 days (+/- 3 days). The duration of treatment will be 7 days, however will be allowed to vary by +/- 3 days dependent upon participant availability to attend. Adherence to the intervention will be maintained through regular daily text messages reminding the participants to take the dose, and will be assessed by weighing the bottle and the solution before dispensation and after the treatment period.
Locations(1)
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ACTRN12621000563864