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Effect of adding atropine to orthokeratology on eye elongation and myopia progression in children.

Effect of adding atropine to orthokeratology on eye elongation and myopia progression in children.

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001046998
Enrollment
32
Registered
2020-10-15
Start date
2021-01-11
Completion date
2021-07-16
Last updated
2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study investigates whether there is any additional benefit of adding atropine 0.025% insertion fluid when using Orthokeratology lenses to slow the progression of myopia (short-sight) in children.

Interventions

Use of atropine (0.025%) as the lubricant fluid used when inserting overnight orthokeratology contact lenses onto the cornea of the (experimental) eye. (The fluid normally used is saline) Dose: one drop, once daily, for two years, when inserting lenses at night. Administered by parent for younger children and by participant for older children: monitored by parental diary in both cases. Cross-over between eyes at one year with no washout period (for example: right eye receives atropine for one ye

Use of atropine (0.025%) as the lubricant fluid used when inserting overnight orthokeratology contact lenses onto the cornea of the (experimental) eye. (The fluid normally used is saline) Dose: one drop, once daily, for two years, when inserting lenses at night. Administered by parent for younger children and by participant for older children: monitored by parental diary in both cases. Cross-over between eyes at one year with no washout period (for example: right eye receives atropine for one year followed by saline for one year, whereas left eye receives saline for one year followed by atropine for one year)

Sponsors

The University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
8 Years to 18 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026