DIMS-myopia Progression ADN Axial Length Growth

Study Overview
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Brief Summary
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To confirm the efficacy of DIMS lenses in controlling myopia progression, we planned a prospective randomized controlled clinical study.

Detailed Description
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The subjects were randomly assigned into two groups: the control group (SV) and the experimental group (DIMS). The clinical trial assistant took the glasses before examination and returned them after examiners had performed all tests. Examiners were unaware of the spectacle type until the end of the follow-up period. However, the lens type was known by children and parents since the unique appearance of the DIMS lens. The subjects were provided details about the study design and methodology and their rights as subjects at first visit. We conducted visual acuity tests, subjective and objective refraction measurements, AL measurements, heterophoria at distance and near, and accommodation after obtaining written informed consent from them and their parent. We conducted follow-up examinations 6 and 12 months after the first visit. In the follow-up examinations, we measured all the examination as do ate the firt visit. Either the VA with the current spectacles dropped to < 0.8(20/20) or SE of cycloplegic subjective refraction increased ≤-0.50D, the lens power of the spectacles was replaced on the basis of the cycloplegic subjective refraction.

Official Title
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Efficacy of Defocus Incorporated Multiple Segments (DIMS) Lens Chinese Myopic Children

Conditions
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Myopia, Progressive

Intervention / Treatment
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* Device: frame lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subjects had spherical RE of -1.00 to -6.50 D, astigmatism ≤ 4.00 D, anisometropia ≤ 1.50 D Best corrected visual acuity (BCVA) equal to or better than logMAR 0.0 (20/20) in both eyes. Exclusion Criteria: Candidate subjects were excluded from the study if they had strabismus, ocular limitations, or systemic abnormalities affecting vision and ocular motility.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 13 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Vision Lens<br>The sunbjects were randomized to allocate in single vision lens group. | Device: frame lens<br>* The subjects were randomized to allocate in Single Vision (SV) lens or Defocus Incorporated Multiple Segments (DIMS) Lens group.<br>|
| Experimental: Defocus Incorporated Multiple Segments (DIMS) Lens<br>The sunbjects were randomized to allocate in Defocus Incorporated Multiple Segments (DIMS) Lens group. | Device: frame lens<br>* The subjects were randomized to allocate in Single Vision (SV) lens or Defocus Incorporated Multiple Segments (DIMS) Lens group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycloplegic objective refraction | Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan). | 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial Length | Axial length (AL) was measured with an AL-Scan optical biometer (Nidek, Japan). | 12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia, axial length, DIMS