Slowing Axial Elongation in Pediatric Myopia: One-Year Clinical Outcomes of Cylindrical Annular Refractive Elements (C.A.R.E.) Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Axial Length
研究概览
简要总结
This prospective interventional study evaluates the effectiveness of Cylindrical Annular Refractive Element (C.A.R.E.) spectacle lenses in slowing axial elongation and myopia progression in children aged 6-12 years. A total of 100 participants with myopia ranging from -0.75 to -6.00 diopters were enrolled and prescribed C.A.R.E. spectacle lenses for full-time wear over a 12-month period. Clinical examinations are conducted at baseline, 6 months, and 12 months and include measurements of axial length, cycloplegic refraction, and visual acuity.
The primary outcome measure is the change in axial length over the 12-month study period. Secondary outcomes include changes in spherical equivalent refractive error, visual acuity, and safety outcomes related to spectacle lens wear.
详细描述
This prospective interventional clinical study was designed to evaluate the effectiveness of Cylindrical Annular Refractive Element (C.A.R.E.) spectacle lenses in slowing axial elongation in children with myopia over a one-year period. The study follows the principles of the Declaration of Helsinki and received approval from the Al-Azhar University Institutional Ethics Committee (Approval No. Ophth._12/2023). Written informed consent was obtained from the parents or legal guardians of all participants prior to enrollment.
Participants
A total of 100 children aged 6-12 years with spherical equivalent refractive error between -0.75 and -6.00 diopters and astigmatism ≤1.50 diopters were recruited. Eligible participants were required to have best-corrected visual acuity of 0.1 logMAR or better and no history of ocular pathology or previous ocular surgery.
Children with amblyopia, strabismus, keratoconus, previous myopia control treatment (such as atropine therapy or orthokeratology), or poor compliance with spectacle wear were excluded.
Intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Not applicable; participants, investigators, and outcome assessors were aware of the intervention.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-12 years at enrollment.
- •Spherical equivalent refractive error between -0.75 and -6.00 diopters.
- •Astigmatism ≤1.50 diopters.
- •Best-corrected visual acuity of 0.1 logMAR or better.
- •Ability to comply with full-time spectacle wear.
- •Informed consent obtained from parent or legal guardian.
排除标准
- •Amblyopia or strabismus.
- •Keratoconus or other corneal pathology.
- •Previous myopia control treatment (e.g., atropine therapy, orthokeratology).
- •History of ocular surgery.
- •Systemic disease affecting vision.
- •Poor compliance with spectacle wear.
研究组 & 干预措施
C.A.R.E. Spectacle Lenses - Pediatric Myopia Control
All participants received Cylindrical Annular Refractive Element (C.A.R.E.) spectacle lenses. The lenses feature a central optical zone for distance correction surrounded by concentric annular cylindrical elements designed to modify peripheral retinal defocus and slow axial elongation. Participants were instructed to wear the spectacles full-time during waking hours for 12 months. Follow-up examinations occurred at baseline, 6 months, and 12 months to assess axial length, refractive error, visual acuity, and safety.
干预措施: Cylindrical Annular Refractive Element (C.A.R.E.) Spectacle Lenses (Device)
结局指标
主要结局
Change in Axial Length
时间窗: Baseline to 12 months
Axial length (AL) will be measured using non-contact optical biometry at baseline, 6 months, and 12 months. The primary outcome is the difference in axial length from baseline to 12 months to evaluate the effect of C.A.R.E. lenses on slowing ocular elongation in children with myopia.
次要结局
- Change in Spherical Equivalent Refractive Error (SER)(Baseline to 12 months)
研究者
Ehab Mohamed Elsayed Mohamed Saad
Lecturer of Ophthalmology
Benha University