Evaluation of the Vision and Fit of Commercially Available Correct Powered (Prescription) Contact Lenses Compared to Lenses Within a Range of ± 2.00 Dioptres (Strength/Power of Lens) From the Prescription
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Soft contact lens movement: Subjective and objective assessment of soft contac tlens movement.
研究概览
简要总结
The purpose of this study is to assess whether changing the optical power (dioptres) of a contact lens has an impact on the vision and fit of the lens. As the modern contact lens users choose daily disposable soft contact lenses for their modality, the trial lenses used (provided by Coopervision) reflect this majority of the market -almost 80% of current UK market. The study will attempt to provide data supporting the use of contact lenses that do not meet a participant's visual needs (± 2.00 dioptres) as a satisfactory alternative when the lens power typically required is not in stock. Currently, there is no existing literature in modern contact lens design that compares the fitting assessment between 'fit-for-purpose' lenses and other lenses within the same design that would not be the final lens choice for the patient in respect to lens power.
详细描述
This study aims to evaluate the vision and fit of commercially available prescription contact lenses of different strengths to determine if this changes the final lens and, if so, how it changes them. In addition, this study will compare subjective comfort, and key fitting criteria such as centration, movement, tightness, coverage and overall impression.
This data could help practitioners use lenses they already have in stock instead of ordering new ones and having patients return. By understanding if these lenses fit similarly, we can make it more convenient for both patients and eye care providers. Patients can get their lenses faster, and eye care providers can use their current stock effectively.
The two visits to take place at the Aston University Eye Clinic, data collection and assessments will include:
Participant's age, ethnicity, sex, ocular history to determine eligibility [recorded electronically on a secure computer]
Standardised OSDI questionnaire (paper copy only; which quantifies dry eye symptoms, severity, and frequency e.g. in the last week how often have your eyes felt gritty, watery, itchy, burning, in the last week how many times have you experienced these) will be administered at the first visit after written consent, will be scanned and upload ed to BOX.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18-60 years of age
- •Vision correctable to at least 6/12 (20/40) or better in each eye
- •with mental capacity to provide written consent in English (as per the Mental Capacity Act, 2005).
- •happy to wear investigational contact lenses
排除标准
- •Any active infection or inflammation, history of major systemic or ophthalmic conditions
- •use of systemic or topical medications known to affect the eye in the previous 3 months
- •history of ocular surgery, currently enrolled on another study/clinical trial that may impact outcome
- •any other contraindications for typical contact lens wear
- •As per the Mental Capacity Act, 2005, participants will be automatically excluded if not deemed to have Capacity for consent or under the age of 18.
结局指标
主要结局
Soft contact lens movement: Subjective and objective assessment of soft contac tlens movement.
时间窗: within 30 mins of lens wear
Lens moevements will be graded between 0.25 - 0.50 mm = Optimum, \<0.25 = Less movement; \>0.50mm is more moevement.
Soft contact lens horizontal lag:Subjective and objective assessment of soft contact lens lag.
时间窗: within 30 mins of lens wear
Lens lag will be graded as: \<50% lag = less leg, 50% to 100% is optimum lag, \>100% = high lag.
Soft contact lens tightness: graded subjectively as optimum, loose and tight
时间窗: within 30 mins of lens wear
Soft contac tlens tightness
次要结局
- Assessment of ocular comfort with soft contact lenses(within 30 mins of lens wear)