Evaluation of Visual Comfort, Adaptation, and Satisfaction With a Myopia Control Lens in Myopic Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Successful Adaptation Rate Within 1 Week After Dispensing
研究概览
简要总结
The goal of this clinical trial is to demonstrate that the visual comfort, adaptation, and overall satisfaction associated with the use of the test spectacle lenses are not inferior to those of the control spectacle lenses in myopic children age ≥ 6 years and < 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is:
Do children adapt to the test spectacle lenses within the first 1-2 weeks of wear without significant symptoms or complaints?
Is the level of visual comfort and overall satisfaction with test spectacle lenses comparable to that of control spectacle lenses during the early adaptation period?
Researchers will compare questionnaire responses between participants wearing test lenses and those wearing control lenses to assess whether the test lenses are non-inferior in terms of visual comfort, adaptation, and user satisfaction.
Participants will:
- Wear the study spectacles for 2 weeks
- Respond to questionnaires 4 days after dispensing and at 2 weeks
- Visit Essilor R&D Centre for screening, dispensing and follow up sessions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer participant who is willing and able to comply with all scheduled study visits.
- •Informed consent of parent/guardian and assent of participant.
- •Age ≥ 6 years and < 11 years at the time of signing informed consent and assent.
- •Spherical equivalent refraction (SER) equal or less than -0.50D and equal or greater than -4.75D with astigmatism not more than 2.00 D on both eyes.
- •Difference in SER (anisometropia) between two eyes should not exceed 1.50 D.
- •Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR in each eye.
- •Be in good general health, based on the participant and the parent's/guardian's knowledge.
排除标准
- •History of Atropine, Orthokeratology, Contact Lens or Red Light treatment.
- •Strabismus by cover test at near or distance wearing correction.
- •History and presence of amblyopia.
- •Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
- •Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
- •History of ocular injury or surgery.
- •Participation in any clinical study within 30 days of the Baseline visit.
- •Sibling of existing participant of this study
- •Study participants deemed inappropriate for the study by the investigator.
- •The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective.
结局指标
主要结局
Successful Adaptation Rate Within 1 Week After Dispensing
时间窗: Within 1 week post dispensing
Proportion of children who meet all of the following criteria at the 1-week visit: 1. Self-reported adaptation: The child confirms feeling adapted to the assigned study lenses, as captured by a pre-specified question in the study questionnaire 2. Absence or resolution of symptoms: The child reports either (i) no symptoms since dispensing, or (ii) complete resolution of any symptoms initially reported at the 4-day visit, as assessed through the symptom checklist in the study questionnaire 3. No lens discontinuation: The child has not discontinued wear of the assigned study lenses prior to the 1-week visit. Non-inferiority of the test lenses will be evaluated against the control lenses based on the between-group difference in adaptation success rates, using a pre-specified non-inferiority margin.
次要结局
- Successful Adaptation Rates at Early and Later Timepoints(4 days and 2 weeks post-dispensing)
- Average daily and weekly wearing time(Assessed at Day 4 and Week 2 post-dispensing)
- Activity-specific visual comfort(4 days and 2 weeks post-dispensing)
- Overall satisfaction(4 days and 2 weeks post-dispensing)
- High-contrast visual acuity (distance and near)(At dispensing (baseline) and 2 weeks post-dispensing)