Part-time Versus Full-time Spectacles for Myopia Control (ParMA Study)

Study Overview
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Brief Summary
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The purpose is to assess the effect of part-time compared to full-time spectacle use in juvenile myopia control.

Detailed Description
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A prospective, randomized, controlled clinical trial was designed for assessing the effect of single-vision spectacles on myopic progression. 30 myopic subjects, aged 6-16 years old, with a spherical equivalent refraction between -0.50D and -6.00D, were recruited. A random number table was used to allocate participants into either a) part-time use of single-vision spectacles, or b) full-time use of single-vision spectacles. Part-time use was for 4-6 hours a day, 7 days a week for a year. Clinical assessment included follow-up at 6 months and at 12 months upon allocation. The primary outcomes were a) change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction, and b) change in axial eye length (AL). The secondary outcomes were a) change in choroidal thickness (ChT), and b) assessment of the subjective tolerance.

Official Title
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Part-time Versus Full-time Spectacles for Myopia Control (ParMA Study)

Conditions
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Myopia

Intervention / Treatment
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* Device: Single-Vision Spectacles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 4 to 16 years old at the time of enrollment. Best-corrected visual acuity (BCVA) LogMAR 0.1 or better, in each eye. Cycloplegic Autorefraction: Myopia, SER between -0.50D and -6.00D, in each eye. Astigmatism less than or equal to 1.50D, in each eye. Anisometropia less than or equal to 1.50D between the two eyes. Absence of any ocular or systemic condition that could influence refractive development, other than myopia. Eagerness to participate in this study and receive myopia treatment in a randomized fashion. Availability for at least 1-year follow-up. Subject parent's or guardian's understanding of the protocol and acceptance to participate, providing a signed consent on behalf of the subject. Exclusion Criteria: Presence of strabismus. Presence of amblyopia. Prematurity (gestational age less than 37 weeks). Presence of an ocular condition affecting refraction (ie. cataract, dislocated lens). Presence of a systemic condition affecting refraction (ie. Down syndrome, Marfan syndrome). Allergy to cyclopentolate. Severe ocular or systemic allergies.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Part-time myopia correction with single-vision spectacles | Device: Single-Vision Spectacles<br>* Spectacle correction for myopia treatment<br>|
| Active Comparator: Control Group<br>Full-time myopia correction with single-vision spectacles | Device: Single-Vision Spectacles<br>* Spectacle correction for myopia treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in spherical equivalent refractive error (SER), measured using cycloplegic autorefraction. |  | Baseline to 6-months, and baseline to 12-months. | 
| Change in axial length (AL). |  | Baseline to 6-months, and baseline to 12-months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in choroidal thickness (ChT). |  | Baseline to 6-months, and baseline to 12-months. | 
| Subjective tolerance, as assessed using a standardized questionnaire created for the purpose of this study. | This questionnaire is formed by the researchers participating in this study and is aimed at providing a qualitative assessment of the subjective tolerance of included children wearing spectacles. It incorporates 6 questions and is not based on a scale. | Baseline to 12-months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Spectacles, Full-time correction, Part-time correction, Childhood