N/A
Completed N=102
Retardation of Myopia in Orthokeratology
Source: ClinicalTrials.gov NCT00962208 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcomePrimary: Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study — 0.36; 0.63 mm
Summary
The primary aim of this study is to evaluate and compare the eyeball elongation in children wearing orthokeratology lenses and single-vision spectacles.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study |
0.36; 0.63 | — |
| SECONDARY Determine the Incidence of Adverse Effects in Cornea, the Palpebral, Bulbar and Tarsal Conjunctiva in the Study and the Control Groups |
— | — |
| SECONDARY Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear |
— | — |
Eligibility Criteria
Inclusion Criteria
- Myopia (refractive sphere): > 0.50D and ≤ 4.00D
- Astigmatism: 0.75D and ≤ 4.50D
- Anisometropia: ≤ 1.50D in both refractive sphere, refractive cylinder and SE
- Best corrected monocular visual acuity: equal to or better than 0.10 in logMAR scale in both eyes
- Willingness for randomization
- Willingness to wear contact lenses or spectacles on a daily basis
- Availability for follow-up for at least 2 years
Exclusion Criteria
- Strabismus at distance or near
- Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex
- Prior experience with the use of rigid lenses (including orthokeratology)
- Prior experience with myopia control treatment (e.g. refractive therapy or progressive add spectacles)
- Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication)
- Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)
Data sourced from ClinicalTrials.gov (NCT00962208). 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.