N/A N=45 Randomized Prevention

Effectiveness of Orthokeratology in Myopia Control

Myopia

Bottom Line

View on ClinicalTrials.gov: NCT03465748 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2023

Primary outcome: Primary: Axial Length — 25.32; 26.08 mm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: OrthoK (Device)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Illinois College of Optometry
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Axial Length	25.32; 26.08	—

Summary

The high prevalence of myopia - especially in Asian countries - is well documented, as are the sight-threatening complications of high or degenerative myopia. Retinal detachment, glaucoma, vitreal degeneration and focal retinal changes may occur secondary to the progressive axial elongation of the eye with age. Specialty rigid lenses have long been shown to lessen this progression in the pediatric population; orthokeratology (ortho-k) lenses are worn at night and change the corneal topography to correct low to moderate amounts of myopia. Most of the studies on orthokeratology were conducted on Asian children. To the best of the investigators knowledge, no study has been done on African American (AA) children. The investigators' project seeks to investigate the efficacy of ortho-k in slowing axial elongation and myopic progression in AA children compared to that in other races.

Eligibility Criteria

Inclusion Criteria

myopia progression more than -1.00D in one year
myopic prescription between -1.00D and -6.00D in at least one eye with refractive astigmatism <1.50D
Best corrected VA 20/25 or better
subjects willing to present to clinic for all necessary follow up care
willing to be randomized to either group

Exclusion Criteria

non-compliance with treatment protocol
contraindications for orthok as per company guidelines
history of refractive surgery
current gas permeable contact lens wearers

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03465748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.