N/A
N=36
Investigation of the Effect of Short-term Orthokeratology With Increased Compression Factor on Ocular Parameters
Myopic Progression
Bottom Line
View on ClinicalTrials.gov: NCT02643875 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Changes in Spherical Equivalent Refraction — 2.31; 2.52 D
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Orthokeratology (Device)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- The Hong Kong Polytechnic University
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Spherical Equivalent Refraction |
2.31; 2.52 | — |
| SECONDARY Changes in Subfoveal Choroidal Thickness |
-1; -6 | — |
| SECONDARY Changes in Higher Order Aberrations |
0.2830; 0.1870 | — |
Summary
Orthokeratology (ortho-k) is a clinical technique that uses reverse geometry rigid gas permeable contact lens exerting positive pressure on the central cornea to temporary reduce refractive error. Researchers have shown that this treatment is effective for myopia control in low to high myopes, with and without astigmatism. Most designs of ortho-k lenses in the market are fitted based on the Jessen formula. The compression factor was introduced to compensate for the regression of the ortho-k effect during the no lens-wear period, so that the wearer can obtain clear distance vision throughout the day and most lens designs use a compression factor of 0.50-0.75 D. However, in a retrospective study (mixed brands of ortho-k lenses), it showed that most patients did not achieve an over-correction of 0.75 D. In order to achieve an over-correction of 0.75 D, an extra flattening power of about 1.50 D instead of 0.75 D should be be targeted. The increased compression factor is expected to increase the target reduction and it may play a role in myopic control and providing a higher successful rate in fitting ortho-k lenses.
Eligibility Criteria
Inclusion Criteria
- 6 to 10 years old
- Myopia: between 0.50 D and 4.00 D in both eyes
- Astigmatism: <1.50 D; ≤ 1.25 D for with-the-rule astigmatism (axes 180 ± 30); ≤ 0.50 D for astigmatism of other axes in both eyes
- Anisometropia: ≤ 1.50 D
- Symmetrical corneal topography with corneal toricity <2.00 D in both eyes
- Agree for randomization
Exclusion Criteria
- Contraindications for orthokeratology wear (e.g. limbus-to-limbus corneal cylinder and dislocated corneal apex)
- Any type of strabismus or amblyopia
- Myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period
- Rigid contact lenses (including orthokeratology lenses) experience
- Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
- Ocular conditions which might affect the refractive error (for example, cataract, ptosis)
- Poor compliance for lens wear or follow-up
Data sourced from ClinicalTrials.gov (NCT02643875). 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.