Role of Advanced Technological Approaches for Myopia Control in Myopic Patients: A Randomized Controlled Trial of Lenslet Spectacles vs. Violet Excitation Filter Glasses vs. Single Vision Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Axial Length
研究概览
简要总结
Myopia, or nearsightedness, is increasing rapidly worldwide, especially in children and young adults. This study tested two advanced treatments for slowing myopia progression with one control group: special lenslet spectacles (Stellest with highly aspherical lenslet technology) and violet excitation filter glasses (wavelength 420 nm) and Single vision lenses for controls. The study enrolled 90 participants aged 8 to 20 years from schools and universities in Faisalabad, Pakistan. Participants were randomly assigned to one of three groups: lenslet spectacles, violet filter glasses, or single vision lenses (control group). Visual acuity, contrast sensitivity, Spherical Equivalent and axial length were measured at the start and again after 3, 6, and 9 months and one follow up after cessation of treatment. The study aimed to determine whether these advanced technologies can effectively slow myopia progression compared to standard glasses, providing head-to-head evidence on emerging and established optical interventions for myopia control.
详细描述
This is a randomized controlled trial (RCT) with three parallel groups. The study was conducted at schools and the Universities in Faisalabad, Pakistan. The total study duration was almost one year (July 2025 to May 2026), with each participant undergoing atleast 3 months of active treatment with 3 follow ups. The sample size was 30 participants per group (total N=90), after drop put of patients, calculated using G*Power (repeated measures ANOVA, 3 groups × 4 time points, medium effect size f=0.25, α=0.05, power=0.8). Simple random sampling was used, with participants allocated to groups using an online research randomizer. Inclusion criteria: axial myopia (high, moderate, or severe), age 8-20 years, both genders, willingness to wear glasses. Exclusion criteria:
other ametropia, contact lens users, prior myopia treatment, ocular or systemic disease, ocular surgery, non-cooperative patients. Lenslet group: Essilor Stellest spectacles with Highly Aspheric Lenslet Target technology, 1.6mm thickness, refractive index 1.56, UV 400nm protection, antireflective coating; worn all waking hours. Violet filter group: plastic lenses with 420nm violet excitation filter; worn 3 hours daily (11 AM to 2 PM) to align with circadian rhythm. Control group: single vision lenses (refractive index 1.56). Primary outcome measures: change in axial length (measured by ocular biometer) and change in cycloplegic refraction. Secondary outcome measures: visual acuity (LogMAR chart), contrast sensitivity (Vistech chart). Follow-up assessments at 3, 6, and 9 months. Statistical analysis: repeated measures Linear mixed model using SPSS version 26 to compare within-group and between-group changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of axial myopia (high, moderate, or severe)
- •Age between 8 and 20 years (inclusive)
- •Male or female
- •Willingness to wear prescribed glasses as instructed
- •Willingness to attend all follow-up visits (3, 6, and 9 months)
- •Written informed consent from participant or parent/guardian for minors
排除标准
- •Any ametropia other than axial myopia (e.g., hyperopia, astigmatism >1.50D)
- •Current contact lens users
- •Prior or concurrent myopia treatment other than study interventions
- •Any ocular disease (e.g., cataract, glaucoma, retinal disorders)
- •Any systemic disease affecting vision (e.g., diabetes, Marfan syndrome)
- •History of any ocular surgery
- •Allergic or physical intolerance to glasses materials
- •Non-cooperative patients unwilling to comply with study procedures
研究组 & 干预措施
Lenslet Spectacles (HALT Technology
Participants receive Essilor Stellest spectacle lenses featuring HALT (Highly Aspheric Lenslet Target) anf violet filter glasses technology. Lenses have 1.6mm thickness, refractive index 1.56, UV 400. Participants are instructed to wear glasses throughout all waking hours for 9 months and for VF atleast 3ours.
干预措施: Lenslet Spectacles (Device)
Violet Excitation Filter Glasses
Participants receive prescription glasses with violet excitation filter (420 nm wavelength, CR-39 material). Participants are instructed to wear glasses for 3 hours daily (11 AM to 2 PM) for 12 months to align with circadian rhythm.
干预措施: Violet Excitation Filter Glasses (Device)
Single Vision Lenses
Participants receive standard single vision spectacle lenses (SVS index 1.56). Participants are instructed to wear glasses throughout all waking hours for 12 months.
干预措施: Single Vision Lenses (Device)
结局指标
主要结局
Change in Axial Length
时间窗: Baseline, Month 3, Month 6, Month 9
Axial length (mm) measured using an A-SCAN biometer (Scanmate 677AB). The measurement represents the distance from the corneal apex to the retinal pigment epithelium. Three measurements are taken for each eye and averaged. This is a continuous anatomical measurement with no theoretical minimum or maximum score. Higher values indicate greater ocular elongation, which is associated with worsening myopia progression.
Change in Cycloplegic Refraction
时间窗: Baseline, Month 3, Month 6, Month 9
Cycloplegic spherical equivalent refraction (SER), measured in diopters (D) using retinoscopy (Welch Allyn) after cycloplegia. SER is calculated as sphere + (cylinder/2). This is a continuous measurement with no theoretical minimum or maximum value. A decrease in SER (more negative values) reflects progression of myopia, while an increase in SER (less negative or more positive values) reflects reduced myopia or a shift toward hyperopia.
次要结局
- Change in Visual Acuity(Baseline, Month 3, Month 6, Month 9)
- Change in Contrast Sensitivity(Baseline, Month 3, Month 6, Month 9)
研究者
Dr Memoona Arshad
Assistant Professor, Department of Optometry
University of Faisalabad