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N/A N=36 Randomized Double-blind Treatment

Investigation of the Effect of Short-term Orthokeratology With Increased Compression Factor on Ocular Parameters

Myopic Progression

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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