None listed
Conditions
Brief summary
This pilot study will be the first to report on the response of myopic (short-sighted) children living in Australia to low dose atropine treatment. It will also examine outdoor/physical activity levels to inform guidelines that balance minimizing the long term effects of myopia (short-sightedness) versus the risks of increased UV exposure. The aim of this study is to test whether a very dilute (0.01%) solution of muscle relaxing mediation (Atropine) given as a single daily eye drop, can slow the progress of myopia. The treatment part of the study will run for 2 years.
Interventions
0.01% atropine eye drops in a vehicle solution of hydroxypropyl methylcellulose 0.5% and boric acid preservative. Administered 1 drop per day, to both eyes, at night for 24 months.
Returned eye drop bottles will be evaluated for volume used over time. It will also be recommended that patents/carers record any accidental missed doses wherever possible in the study diaries provided.
Sponsors
Lions Eye Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
Aged 6-16 years Myopia with spherical equivalent refractive error greater or equal to -1.5D in each eye Documented myopic progression of greater or equal to -0.5D over the previous 12 months in either eye Astigmatism less than -1.5D An intraocular difference in spherical equivalent < 1D Corrected visual acuity greater than logMar 0.2 Normal IOP Normal ocular health No history of cardiac/respiratory disease Willing and able to provide details of parents country of origin Able to provide appropriate parental/carer consent
Exclusion criteria
Children who are currently wearing or have worn orthokeratology lenses over the previous two years for myopia control.
Outcome results
None listed