Dual-focus Soft Contact Lenses for the Treatment of Adult Myopia Progression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Cycloplegic Spherical Equivalent Refraction
研究概览
简要总结
Myopia (nearsightedness) can continue to worsen during young adulthood, increasing the risk of sight-threatening eye diseases later in life. Although dual-focus soft contacts (DFSC) lenses have been shown to slow myopia progression in children, their effectiveness in adults is not well understood. This study will compare DFSC lenses with standard single-vision soft contact (SVSC) lenses in myopic young adults aged 18 to 30 years. Participants will be randomly assigned to wear one of the two lens types for 24 months. The study will measure changes in axial length and cycloplegic refractive error to determine whether DFSC lenses slow myopia progression in young adults.
详细描述
This is a prospective, single-center, randomized, double-masked, parallel-group clinical trial designed to evaluate the efficacy of DFSC lenses for slowing myopia progression in young adults. Approximately 152 participants aged 18 to 30 years with documented ongoing myopia progression. will be randomized in a 1:1 ratio to wear either MiSight 1 day DFSC lenses or Proclear 1 day SVSC lenses for 24 months. The co-primary outcomes are changes in axial length and cycloplegic spherical equivalent refractive error over 24 months. Secondary outcomes include changes in choroidal parameters, including thickness, accommodation, and ocular safety. Outcome assessors will remain masked to treatment allocation throughout the study.
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
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender, aged 18-30 years, inclusive.
- •Successful previous contact lens wearer
- •Documented ongoing myopia progression (at least 0.50D over past 2 years)
- •Refractive error meeting the following by cycloplegic autorefraction:
- •Myopia -0.50D to -5.00D SER in both eyes
- •Astigmatism (absolute value) ≤ 1.50 D in both eyes
- •Anisometropia < 1.50 D SER.
- •Best-corrected distance visual acuity (BCDVA) in current correction as follows:
- •0.1 logMAR or better
- •Interocular difference ≤ 0.1 log MAR
排除标准
- •Current or previous use of pharmacologic or optical myopia control treatment within the past 2 years.
- •Any ocular disease or abnormality affecting the cornea, lens, retina, iris, ciliary body, choroid, or sclera.
- •History of manifest strabismus, amblyopia, or nystagmus.
- •Previous eyelid, strabismus, intraocular, or refractive surgery. I- ntraocular pressure >26 mmHg.
- •of premature birth (≥6 weeks before the due date).
- •Neurological disorders, genetic syndromes, or other conditions that would interfere with completion of study procedures.
- •Known allergy or hypersensitivity to fluorescein, proparacaine, or tropicamide.
- •Conditions associated with degenerative myopia or abnormal ocular anatomy (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity, keratoconus, lenticonus, or spherophakia).
- •Regular use of ocular medications, artificial tears, or wetting agents.
- •Current use of systemic medications that may affect contact lens wear, tear film, pupil size, accommodation, electrophysiology, or refractive state.
- •Diagnosis of or treatment for attention-deficit/hyperactivity disorder (ADHD) or a learning disability.
- •Systemic disease that may affect visual function (e.g., diabetes mellitus).
- •Ocular inflammation within 30 days before screening.
- •Slit-lamp findings that contraindicate contact lens wear (e.g., corneal scars, corneal neovascularization, giant papillary conjunctivitis).
- •Blepharospasm or other eyelid abnormalities that interfere with contact lens wear.
- •Any severe ocular or systemic condition that, in the investigator's judgment, would interfere with study participation or follow-up.
研究组 & 干预措施
Treatment
Participants will wear MiSight 1 day dual-focus soft contact lenses on a daily-wear basis for 24 months according to the study protocol.
干预措施: Dual Focus Soft Contact Lens (Device)
Control
Participants will wear Proclear 1-day single-vision soft contact lenses on a daily wear basis for 24 months according to the study protocol.
干预措施: Single Vision Soft Contact Lens (Device)
结局指标
主要结局
Cycloplegic Spherical Equivalent Refraction
时间窗: Baseline, 12 months, and 24 months
Change in cycloplegic spherical equivalent refraction (diopters) from baseline, measured by cycloplegic autorefraction after instillation of 1% tropicamide. Spherical equivalent will be calculated as sphere + one-half cylinder. The mean change from baseline will be compared between the DFSC and SVSC lens groups.
Axial Length
时间窗: Baseline, 12 months, and 24 months
Change in axial length (millimeters) from baseline. The mean change from baseline will be compared between two groups
次要结局
- Acute Change in Choroidal Thickness(Baseline (pre-lens adaptation) and immediately following 30 minutes of contact lens wear (post-lens adaptation).)
- Quality of Vision(Baseline, 2 weeks, 12 months, and 24 months)
- Accommodative Response(Baseline, 2 weeks, 6 months, 12 months, and 24 months)
- Ocular Safety(Baseline through 12 months and Baseline through 24 months)
- Longitudinal Change in Choroidal Thickness(Baseline, 6 months, 12 months and 24 months)