N/A
Completed N=91
Discontinuation of Lens Wear in New Ortho-k Children (DOEE2)
Source: ClinicalTrials.gov NCT01236755 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Change in Axial Elongation in the Two Study Phases — 0.163; 0.047 mm
Summary
This study aims at investigating the efficacy of myopic control using ortho-k in younger and older children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Axial Elongation in the Two Study Phases |
0.163; 0.047 | — |
| SECONDARY Number of Participants With Serious Adverse Effects |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age: between 6 to 15 years old
- Myopia: between 1.50D and 4.50D in at least one eye
- Spherical equivalent (SE): between -1.00D to -4.50D in both eyes
- Astigmatism: ≤ 3.00D of axes 180 +/- 30 or ≤ 1.00D of other axes; and the amount is less than refractive sphere
- 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 to wear contact lenses or spectacles on a daily basis
- Can obtain good ortho-k results with the study lenses
- Availability for follow-up for at least 14 months
Exclusion Criteria
- Strabismus at distance or near
- Contraindication for contact lens wear and ortho-k (e.g. limbus to limbus corneal cylinder and dislocated corneal apex
- 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)
- Prior experience with the use of rigid lenses (including ortho-k)
- Prior experience with myopia control treatment (e.g. refractive therapy or progressive spectacles)
- Non-compliance to the follow up schedule
- Non-compliance to the use of the prescribed optical correction
- Poor ocular response to ortho-k lens wear
- Significant residual refractive error after ortho-k treatment resulting in poor unaided vision (worse than 0.18 in logMAR scale)
Data sourced from ClinicalTrials.gov (NCT01236755). 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.