WithdrawnPhase 3ACTRN12620001046998

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


Sponsor

The University of Auckland

Enrollment

32 participants

Start Date

Jan 11, 2021

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 8 YearssMax Age: 18 Yearss

Inclusion Criteria3

  • 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 Criteria4

  • 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

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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 d

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)


Locations(1)

Christchurch, New Zealand

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ACTRN12620001046998