Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
60

Summary

Conditions
Myopia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 6 years and 13 years
Gender
Both males and females

Description

Orthokeratology (ortho-k), when used for partial or full correction of myopia, has been shown to slow myopic progression in children by 36-56% as compared to their spectacle or contact-lens wearing peers.1 This effect is achieved by limiting the axial elongation of the eye,1, 2,3, 4 which is of part...

Orthokeratology (ortho-k), when used for partial or full correction of myopia, has been shown to slow myopic progression in children by 36-56% as compared to their spectacle or contact-lens wearing peers.1 This effect is achieved by limiting the axial elongation of the eye,1, 2,3, 4 which is of particular concern in high myopes (>6.00D) and children, where myopic progression has been shown to proceed at a faster rate than average.1 As early intervention is considered beneficial if not essential, Ortho-k as a treatment modality for diminishing myopic progression has, to our knowledge, been studied mostly in Asian children. The safety and efficacy of ortho-k as a means of decreasing myopic progression was well established by the Children's Overnight Orthokeratology Investigation (COOKI), who evaluated refractive error, visual changes and ocular health over a period of 6 months in myopic children. 7 The Longitudinal Orthokeratology Research in Children (LORIC) study looked at axial elongation in children as old as 12 years, and found that ortho-k decreased axial elongation by approximately 50% compared to be-spectacled controls. 2 They also noted, however, high variability amongst the children that limits the clinician's ability to predict the outcome of the intervention.2 The Corneal Reshaping and Yearly Observation of Myopia (CRAYON) study confirmed that patients fit with ortho-k lenses showed less change in axial length and vitreous chamber depth when compared to subjects wearing soft contact lenses. 3 Other more recent studies by Santodomingo-Rubido et al, 7 Kakita et al4 and Charm et al1 confirm this decrease in axial elongation using IOL Master measurements. The most commonly accepted theory on how orthokeratology decreases axial elongation relies on the peripheral defocus created on the retina by the corneal changes made by the rigid lens. 9 Hoogerheide et al showed that those at greatest risk for myopic progression were those whose peripheral refraction was hypermetropic10 - that is, they had a hyperopic peripheral 'defocus'. A number of studies have since suggested that treatment approaches to myopia correction should address this peripheral refraction as a means of slowing further axial elongation.9 When looking at subjects treated with ortho k, we see that the lenses do in fact introduce a peripheral myopic defocus while leaving the central refraction more or less emmetropic. 9 With this study, the investigators hope to expand potential application of orthokeratology to a novel population, AA children.

Tracking Information

NCT #
NCT03465748
Collaborators
Wesley Research Institute
Investigators
Study Chair: Yi Pang, OD Illinois College of Optometry