A Unified Index to Predict the Success Probability of Myopia Control

Study Overview
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Brief Summary
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Orthokeratology lenses (OK-lens) and multifocal contact lenses (MFCL) are optical devices designed to slow down the progression of myopia. Both treatments a long-term commitment from doctors and patients. This study aims to develop a unified index to predict the success probability of myopia control at the early stage of treatment.

Detailed Description
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An Orthokeratology lens (OK-lens) is a rigid contact lens with a reverse geometry on its back surface. Overnight OK-lens wearing flattens the central cornea (creating minus power) and steepens the mid-peripheral cornea (creating plus power). During the day, this inverted pattern of peripheral corneal refraction induces relative peripheral myopic defocus on the retina to slow down the axial growth. The central portion of an MFCL is designed with minus powers to correct for distance vision, and plus power is directly added to the peripheral part of the lens. Daytime MFCL wear imposes peripheral retinal myopic defocus when the lenses are worn. An MFCL can also reduce axial growth by 52% compared to a single vision spectacle or contact lens. Myopia control with OK-lens or MFCL requires a long-term commitment from doctors and patients to see the effect become apparent. It is paramount to estimate the probability that a patient would achieve effective control in myopic progression ideally before treatment begins or early during the course of treatment. To this end, efforts have been made to investigate the correlations between axial growth and possible contributing factors. Early research works have covered a variety of parameters at the baseline, including age, spherical equivalent (SE), corneal eccentricity, and corneal thickness. These measurements are nonspecific, indirect, and based on the assumption that their relationships to axial growth are linear, which often leads to contradictory findings and results that are hard to interpret by physicians. Therefore, in this study, we proposed a new index that takes pupil size into consideration by determining the summed relative myopic defocus dosage within the pupillary area (PMDD) to predict myopia control's success rate. This index will be determined for each eye, will be quantified one month after the lens dispensing, and will be used as the predictive variable.

Official Title
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A Unified Index to Predict the Success Probability of Myopia Control

Conditions
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Myopia, Progressive

Intervention / Treatment
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* Device: orthokeratology lens
* Device: multifocal soft contact lens
* Device: Single vision spectacles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 7 years of age or younger than 12 years of age, Spherical equivalent (SE) greater -1.00 D and less than-5.00 D, Corneal astigmatism ≤ 1.50 D, best-corrected visual acuity better than 20/25, No binocular vision dysfunction, No obvious angle kappa, No history of an OK-lens or MFCL wear or any other myopia control treatments such as atropine, application of atropine for cycloplegia during the past 30 days, No contact lens contraindications, No related ocular or systemic disease. Exclusion Criteria: Younger than 7 years of age or older than 12 years of age, Spherical equivalent (SE) less than -1.00 D or greater than-5.00 D, Corneal astigmatism > 1.50 D, Best-corrected visual acuity less than 20/25, Binocular vision dysfunction, Obvious angle kappa, History of an OK-lens or MFCL wear or any other myopia control treatments such as atropine, application of atropine for cycloplegia during the past 30 days, Contact lens contraindications, Related ocular or systemic disease.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: orthokeratology lens<br>The subjects will wear an orthokeratology lens with 3-zone reverse geometry design. The subjects are instructed to wear the lenses for at least eight hours every night and are removed during daytime hours. | Device: orthokeratology lens<br>* Subjects will wear orthokeratology lens at night. Axial length elongation over a period of 12-month will be recorded.<br>|
| Experimental: multifocal soft contact lens<br>The subjects will wear a multifocal soft contact lens during daytime hours and remove the lens at night | Device: multifocal soft contact lens<br>* Subjects will wear multifocal soft contact lens during the day time. Axial length elongation over a period of 12-month will be recorded.<br>|
| Active Comparator: single vision spectacle<br>The subjects will wear single vision spectacle lens as control. | Device: Single vision spectacles<br>* Subjects will wear single vision spectacles during the day. Axial length elongation over a period of 12-month will be recorded.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| axial length elongation | The changes in axial length at the end of 12-month treatment will be computed. | over 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pupillary myopia defocus dosage | The myopia defocus dosage accumulated within the pupillary area | over 12 months |