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

Study Overview
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Brief Summary
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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.

Detailed Description
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Subjects were fitted with ortho-k lenses of conventional (0.75 D) and increased (1.75 D) compression factor. The laterality of the compression factor for each subject was randomised. Subjects were instructed and trained with proper lens handling and disinfection procedures. Lenses were given to the subjects only when they demonstrated proper techniques. All subjects were required to attend regular follow-ups (baseline, first overnight, and weekly over one-month period). The follow-ups were scheduled (except for the first overnight which was scheduled in the early morning) at a similar time to the baseline visit (+/- 2 hours) to minimise any potential influence of diurnal variation on ocular biometrics. Additional unscheduled visits were provided when necessary to ensure good ocular health and vision throughout the study period.

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

Conditions
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Myopic Progression

Intervention / Treatment
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* Device: Orthokeratology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Ortho-k lens with normal compression factor<br>The eye wears ortho-k lens with normal compression factor to achieve plano (+/- 0.25D) correction. | Device: Orthokeratology<br>* It is a kind of rigid permeable lens.<br>|
| Active Comparator: Ortho-k lenses with increased compression factor<br>The eye wears ortho-k lenses with increased compression factor to achieve 1 diopter (+/- 0.25D) over correction. | Device: Orthokeratology<br>* It is a kind of rigid permeable lens.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Spherical Equivalent Refraction | Maximum plus for maximum visual acuity was used as the criterion for subjective refraction. Spherical equivalent refraction was calculated by adding the sum of the sphere power with half of the cylinder power. | baseline and one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Subfoveal Choroidal Thickness | The subfoveal choroidal thickness was determined as the thickness between the outer retinal pigment epithelium/Bruch's membrane complex and the inner chorioscleral interface. | baseline and one month | 
| Changes in Higher Order Aberrations | Ocular higher order aberrations were measured using Shack-Hartmann aberrometer. The wavefront data was fitted with a sixth order Zernike polynomial over a 5-mm pupil size. | baseline and one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia control, orthokeratology