Adaptation To and Satisfaction With Contact Lens Wear In Myopic Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Subjective Quality of Vision (QoV)
研究概览
简要总结
The purpose of this study was to assess whether young adults could adapt to and achieve satisfaction with a daily disposable contact lens.
详细描述
This was a prospective, single group, dispensing clinical trial to determine subjective and objective visual performance measures, patient satisfaction and adaptability to a commercially available daily disposable contact lens in myopic young adults over 3 months of daily lens wear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is between 17 and 25 years of age (inclusive) and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Has a vertex corrected spherical equivalent distance refraction that ranges between - 0.75D to -6.00D in each eye;
- •Has astigmatism ≤ -0.75 DC in either eye, by refraction;
- •Be correctable to better than 0.20 logMAR in each eye by refraction;
- •Has habitually worn spherical soft contact lenses to correct for distance vision (i.e. no multifocal or monovision) for the past 3 months;
- •Is willing to wear contact lenses for at least 10 hours a day, 6 days a week while in the study;
- •Demonstrates an acceptable fit with the study lenses;
- •Has ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses.
排除标准
- •Is participating in any concurrent clinical or research study;
- •Has a history of amblyopia;
- •Has TNO Stereoacuity worse than 120" arc / or Titmus worse than 100" arc;
- •Has any known active ocular disease and/or infection;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Has known sensitivity to the diagnostic pharmaceutical (sodium fluorescein) to be used in the study;
- •Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation at the screening visit);
- •Is pseudophakic;
- •Has undergone refractive error surgery;
- •Has one of following experiences with MiSight lenses:
- •Is currently wearing MiSight lenses or
- •Has worn MiSight lenses for more than one week at any given time or
- •Has worn MiSight lenses for any more than 30 minutes in the past 30 days;
- •Has had orthokeratology treatment within the last 3 months.
研究组 & 干预措施
Daily disposable contact lens
Participants wore a daily disposable contact lens for 3 months.
干预措施: daily disposable contact lens (Device)
结局指标
主要结局
Subjective Quality of Vision (QoV)
时间窗: 3 months
The Subjective Quality of Vision (QoV) questionnaire consisted of 30 items assessing 10 visual symptoms. Each symptom was evaluated using three sub-questions: frequency, severity, and bothersomeness. All subquestions were rated on a 4-point scale from 0 to 3, where higher values represent a higher severity, frequency, or bothersomeness. For analysis, each dimension-frequency, severity, and bothersomeness-was treated independently. Scores for each were calculated by summing the responses across all 10 symptoms, resulting in separate total scores for each dimension. Each total score ranged from 0 to 30. Thus, the Overall Frequency of Symptoms, Overall Severity, and Overall Bothersomeness scores each represent the sum of the respective ratings across all visual symptoms.
次要结局
- Contact Lens Impact on Quality of Life (CLIQ)(3 months)