MultifocAL COntact Lenses for Myopia and Their Effect on Axial Length Elongation in Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Axial length progression
研究概览
简要总结
This study will compare the effects on myopia progression over the course of one year for eyes wearing MiSight 1 Day contact lenses compared to ACUVUE OASYS for PRESBYOPIA contact lenses.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Aged 6-12 years (inclusive)
- •Is willing to wear soft contact lenses daily
- •Spherical equivalent myopic refractive error between -0.50 to -5.00 D in each eye and astigmatism < 1.00 D
- •Best corrected logMAR visual acuity of 0.1 or better in both eyes
- •Good ocular and general health
- •No previous use of myopia control interventions for more than 1 month or within the last 30 days
- •Competent enough in English to be able to fully understand the participant information and consent form
排除标准
- •Strabismus at distance or near, amblyopia or significant anisometropia (>1D)
- •Systemic or ocular conditions that may affect contact lens use (e.g., allergy) or that may affect refractive development (e.g., ptosis)
- •Previous history of ocular surgery, trauma, or chronic ocular disease
- •Contraindications to contact lens use
- •Ocular or systemic medication use which may interfere or interact with contact lens wear or ocular development
- •Plans to migrate or move during the study
- •Child, parents or guardians not willing to comply with treatment and/or follow-up schedule
结局指标
主要结局
Axial length progression
时间窗: 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants.
Change in Axial Length between two eyes measured by laser interferometry (IOL Master)
Cycloplegic autorefraction
时间窗: 1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants.
Change in Autorefraction between two eyes as measured by autorefractor
次要结局
- Subjective refraction(1 month, 6 months and 12-months post intervention commencement. Initial protocol also included 3-month time point, but the 3-month visit was updated to a telehealth consultation due to COVID-19 restrictions. Updated after 9 participants.)
- Estimates of outdoor time and near work(1-month, 6-month and 12-month study visits. Also 3-month and 9-month telehealth visits. 3-month visit was changed to telehealth and 9-month visit added after already enrolling 9 participants.)
- Quality of Life (PREP2)(Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants.)
- Quality of Life (PedEyeQ)(Baseline, 6-month and 12-month study visits. Added after already enrolling 9 participants.)
- Treatment adherence (Questions)(1-month, 6-month and 12-month study visits. Added to initial protocol prior to enrolment commencement.)
- Treatment adherence (Text-message surveys)(Study month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12. 1-month, 6-month and 12-month study visits. Added to initial protocol prior to enrolment commencement.)
研究者
Pauline Kang
Associate Professor
The University of New South Wales