Assessment of Tear Production, Corneal Staining, and Comfort Level After One Day of Wearing FDA Group I, II, III, IV, and V Contact Lenses Among Pre-Graduate Students at UKM Kuala Lumpur Campus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- To assess the quantity of tears in eyes wearing contact lenses
研究概览
简要总结
This research assesses the tear performance of five distinct types of soft contact lenses commonly found in the market. The study involves contact lens participants, all of whom are students enrolled at UKM. Before the study, participants were instructed to discontinue wearing their usual contact lenses for two weeks. The lenses utilized in this clinical trial all possess current refractive power. Participants are required to wear the lenses for an entire day only. Upon completion of the study, participants will be requested to complete a brief questionnaire.
详细描述
Before commencing the trial, all participants will undergo an anterior segment examination to ensure the eyes are in a healthy state, free from corneal diseases. Two parameters will be measured during this examination: Tear Break-Up Time (TBUT), which is a non-invasive method used to assess tear break-up, and the Schirmer Test, where a strip is placed on the lower eyelid for five minutes to evaluate tear wetting of the strip.
The level of comfort after wearing contact lenses for 8 hours will be assessed using the Contact Lens Discomfort Index questionnaire.
The sample size is determined using the formula by Daniel (1999). Ten percent of the total sample size represents the number of subjects for this study. Considering a dropout rate of 10%, this study requires 18 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The 6 types of Contact Lenses used will be labeled as A, B, C, D, E, and F by a co-investigator and will be fitted on the participant's eye randomly.
入排标准
- 年龄范围
- 19 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
- •Age 19-29 years old
- •Refractive error is less than -6.00DS with astigmatism is less than -1.00DC
- •Have experience wearing Contact Lenses but agree to stop wearing them for 2 weeks before the study starts
排除标准
- •smokers (Ward et al. 2010)
- •participants with ocular disease or trauma which includes Lasik patients and intra/extraocular surgery.
- •pregnant females (Yenerel & Kucumen 2015).
- •participants taking medication for systemic diseases (Fraunfelder et al. 2012).
结局指标
主要结局
To assess the quantity of tears in eyes wearing contact lenses
时间窗: 5 minutes
Schirmer Test is done on patients pre and post-wear. Results will be taken after 5 minutes of measurement using Schirmer Strips
To asess the quality of tears in eyes wearing contact lenses
时间窗: 5 minutes
NIBUT is done on patients pre and post wear. (10 seconds)
To assess comfort level of participants using CL Discomfort Index Questionaire
时间窗: 10 minutes
8 questions to be answered for each lens
To assess corneal staining in eyes wearing contact lenses
时间窗: 5 minutes
Fluorescein in instill at the conjunctiva and staining is observed using cobalt blue light
次要结局
未报告次要终点