N/A
Completed N=45
Effectiveness of Orthokeratology in Myopia Control
Source: ClinicalTrials.gov NCT03465748 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Axial Length — 25.32; 26.08 mm
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Axial Length |
25.32; 26.08 | — |
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
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. Informational only — not medical advice.