Choroidal Responses to the Modified Defocus Incorporated Multiple Segments (DIMS) Spectacle Lenses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Choroidal thickness changes
研究概览
简要总结
The goal of this study is to investigate the short-term changes in choroidal thickness and efficacy of the study spectacle lenses in children. Participants will be prescribed with a pair of study spectacle lenses for daily use and visit the clinic once every week for the first month for checkup and tests. After the first month of follow-up, participants will visit at 1 month, 6- and 12-month for checkup. Choroidal thickness, axial length and refractive errors will be monitored.
详细描述
Optical interventions have been widely used for myopia control in children, however, the effectiveness varied between individuals. The current study spectacle lenses are modified based on DIMS technology.
Participants will be randomly allocated to single vision (SV) lens group (control), D1 or D2 group (treatment). The weekly choroidal thickness changes will be monitored in the first month of lens wear. Their cycloplegic refraction and axial length will be monitored every 6 months for 1 year.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Both participants and their guardians will be masked from the grouping. The outcomes assessors will be also masked from the grouping.
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hong Kong Chinese
- •Age at enrolment: 6 - 13 years
- •Myopia in spherical power: -1.00D to -5.00D in both eyes
- •Astigmatism: equal or less than 2.00D
- •The sum of spherical power and astigmatism: equal or less than -7.00D
- •Anisometropia (spherical equivalent refraction (SER)): equal or less than 1.50D
- •Previous myopia progression (valid documentation dated within 2 years before screening):
- •-0.50D (SER) per year or more in both eyes OR Axial length elongation: 0.27mm/year in both eyes
- •If myopia is initially detected during screening, eligibility requires myopia (in SER) below the 3rd percentile curve of refraction in both eyes.12
- •Best corrected visual acuity: LogMAR 0.04 or better in both eyes
- •Ocular health: no abnormalities in both internal and external ocular health
- •Binocular vision: no strabismus and other binocular abnormalities
- •Normal colour vision
- •Willing to wear the study spectacles all the time (10 hours per day, for 7 days per week)
排除标准
- •Previous or current treatment for myopia control (e.g., red-light therapy, atropine, orthokeratology, specialized spectacle lenses and contact lenses and oral supplements for myopic control)
- •Existing or past eye diseases or surgeries (e.g., strabismus surgery, amblyopia, oculomotor nerve palsies, corneal disease, intraocular disease, etc.) that may have an impact on vision or visual development
- •Long-term medication (intake at least 3 days/week) or medication/supplements that affect eye health
- •Systemic diseases that may have an impact on vision or visual development (e.g., endocrine, cardiac and respiratory diseases, diabetes, Down syndrome, etc.)
- •Allergic to cyclopentolate eye drops
- •Individuals who, in the judgment of the Investigator, are unable to cooperate and follow instructions during eye examination.
研究组 & 干预措施
Single vision lens group
Participants in single vision lens group will receive a pair of single vision lenses for 1 year after the short-term monitoring of choroidal thickness.
D1 lens group
Participants in D1 lens group will receive a pair of D1 lenses over 1 year after the short-term monitoring of choroidal thickness.
干预措施: Modified Defocus Incorporated Multiple Segments lens (D1) (Other)
D2 lens group
Participants in D2 lens group will receive a pair of D2 lenses over 1 year after the short-term monitoring of choroidal thickness.
干预措施: Modified Defocus Incorporated Multiple Segments lens (D2) (Other)
结局指标
主要结局
Choroidal thickness changes
时间窗: Baseline, every week for 1 month, every 6 months over 1 year
Choroidal thickness will be measured by a swept source optical coherence tomographer. Changes in choroidal thickness from baseline over the first month and every 6 months for 1 year over the study period.
次要结局
- Cycloplegic refraction change in spherical equivalent refraction (SER)(Baseline, 6 and 12 months)
- Axial length changes(Baseline, 6 and 12 months)