Efficacy of SEED's Novel Anti-myopia Contact Lens (Daily Disposable) in Controlling Myopia Progression
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Central refractive error changes
研究概览
简要总结
This randomized clinical trial study aims to investigate the efficacy of novel SEED's EDOF based mid-lens design in controlling the myopia progression in
Indian children with these specific objectives:
- To investigate the efficacy of SEED's 1-day pure extended depth of focus lenses controlling myopia progression in Indian children through a one-year randomized clinical study.
- To investigate the role of SEED's 1-day pure extended depth of focus lenses in altering peripheral refraction of the eye to control myopia progression.
- To determine if there is any specific cohort that shows better efficacy in myopia control with 1-day pure extended depth of focus lenses based on central and peripheral optics (degree of myopia and optical parameters).
- To investigate the qualitative assessment of comfort and visual experience with the SEED's EDOF contact lenses through the questionnaire method.
详细描述
This prospective randomized controlled clinical trial will be conducted in Myopia Research Lab, L V Prasad Eye Institute, Hyderabad and the study protocol will adhere to the tenets of the Declaration of Helsinki. Participants will be recruited through advertisements in local print media (newspaper), approaching schools, through clinical referrals. Children will be assigned to either the control group or intervention group randomly based on computer-generated random numbers operated by the investigator. All participants will undergo a cycloplegic refractive error assessment after the instillation of tropicamide 1% eye drops (or cyclopentolate 1% eye drops in case of varying refractive error between objective and subjective values). Axial length and cycloplegic refractive measurements will be taken with using Lenstar LS900 biometer and Shin- Nippon autorefractor respectively for scheduled follow up and will be compared with the baseline parameters.
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 (Participant)
盲法说明
Single Masked Randomized Study
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Myopia (SE) between -0.50D to -10.00D
- •Astigmatism less than 0.75D
- •Anisometropia less than 1.00D
- •Age of the participant from 7 to 15 years
- •Neophyte or existing soft contact lens wearer
- •Best-corrected visual acuity (BCVA); ≤ 20/20
- •Participants who are willing to wear the contact lens constantly
排除标准
- •Participants who had any ocular or systemic conditions that could influence the refractive error
- •Poor compliance of contact lenses from existing wearer
- •Prior use of orthokeratology lenses/bifocal lenses/anti-myopia strategies
- •Participants who had any medications that could influence the refractive error
结局指标
主要结局
Central refractive error changes
时间窗: Data will be collected at baseline, 3 months, 6 months and 12 months.
1. Changes (1 year) in spherical equivalent refractive error (dioptre) in the intervention and control group from the baseline. 2. Changes (1 year) in spherical equivalent refractive error (dioptre) among different degrees of myopia in the intervention and control group from the baseline.
Axial length changes
时间窗: Data will be collected at baseline, 3 months, 6 months and 12 months.
1. Changes (1 year) in axial length (millimetre) in the intervention and control group from the baseline. 2. Changes (1 year) in axial length (millimetre) among different degrees of myopia in the intervention and control group from the baseline.
Peripheral refractive error changes
时间窗: Data will be collected at baseline, 3 months, 6 months and 12 months.
1. Changes (1 year) in peripheral spherical equivalent refractive error (dioptre) of the individuals in the intervention and control group from the baseline. 2. Changes (1 year) in peripheral spherical equivalent refractive error (dioptre) among different degrees of myopia in the intervention and control group from the baseline.
次要结局
- Qualitative assessment(Data will be collected at 3 months, 6 months and 12 months.)
研究者
Dr. Pavan Verkicharla
Scientist-Myopia Research Lab
L.V. Prasad Eye Institute