Effect of adding atropine to orthokeratology on eye elongation and myopia progression in children.
Phase 3
Withdrawn
- Conditions
- Myopia (short-sight)Eye - Diseases / disorders of the eye
- Registration Number
- ACTRN12620001046998
- Lead Sponsor
- The University of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Between 8 to 18 years of age
Have successfully worn Orthokeratology for more than 3 months.
Have a spectacle prescription of -0.75D to -6.00D spherical equivalent
Exclusion Criteria
A difference in prescription between the two eyes greater than 1.50 Diopters
Amblyopia, cataract or strabismus
On medication that may interact with atropine
A known allergy to anticholinergic drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in axial eye length measured with non-contact ocular biometer.[Assessed at Baseline, 6 months, 12 months (primary timepoint), 18 months, 24 months, 30 months and 36 months after commencing intervention, ];Change in refractive error, measured by cycloplegic autorefraction.[Assessed at Baseline, 6 months, 12 months (primary timepoint), 18 months, 24 months, 30 months and 36 months after commencing intervention, ]
- Secondary Outcome Measures
Name Time Method Pupil diameter, measured with pupillometer[Assessed at Baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months after commencing intervention, ];Corneal Topography (i.e. shape of the cornea) measured with a corneal topographer.[Assessed at Baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months after commencing intervention, ];Intraocular pressure (IOP) measured with non-contact tonometry.[Assessed at Baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months after commencing intervention, ]