A Comparative Study on Functional Vision in Astigmatic Patients: DAILIES TOTAL1 Toric Contact Lenses vs. Spherical Equivalent Contact Lenses in Asian Eyes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Near high-contrast visual acuity (40cm)
研究概览
简要总结
The goal of this comparative clinical trial is to assess the effectiveness of DAILIES TOTAL1 Toric Contact Lenses compared to Spherical Equivalent Contact Lenses in improving the functional vision of astigmatic patients, with a particular focus on Asian individuals who frequently use digital devices.
The main questions it aims to answer are:
How do DAILIES TOTAL1 Toric Contact Lenses affect the quality of vision in daily activities, especially when using digital screens, compared to Spherical Equivalent Contact Lenses?
What is the level of comfort and overall satisfaction among participants using DAILIES TOTAL1 Toric Contact Lenses versus those using Spherical Equivalent Contact Lenses?
Participants will be asked to wear both types of contact lenses for a specified period. During this time, they will perform various tasks involving digital screens. Their vision quality and comfort levels will be monitored and recorded. They will also be asked to report their satisfaction with each type of lens and any differences in their experience with screen use.
详细描述
Background:
In today's digital age, individuals spend a significant amount of time using digital devices [1]. This is notably challenging for individuals with astigmatism, a condition that can impair visual acuity when using these devices [2]. Despite the prevalence of astigmatism, toric contact lens technology, which can potentially improve visual acuity for these individuals, remains underused [3][4]. Many eye care practitioners opt for spherical lenses due to perceived complexities of fitting and considerations of cost-effectiveness [5][6].
DAILIES TOTAL1® for Astigmatism contact lenses, the first and only daily disposable Water Gradient toric contact lenses, can potentially address this issue. These lenses represent a significant innovation in toric contact lens technology, offering a unique combination of breathability and exceptional comfort. The lenses utilize Water Gradient Technology, creating a gradual transition in water content from the core to the surface of the lens, with the water content approaching 100% at the lens surface. This technology enables these lenses to offer a combination of high breathability and exceptional comfort.
Unmet Medical Need:
Although toric lenses, including DAILIES TOTAL1® for Astigmatism, have been shown to improve visual acuity in astigmatic patients, their impact on real-world visual performance, particularly when using digital devices, is less understood [1]. Additionally, while many practitioners gravitate towards spherical lenses, astigmatic patients could greatly benefit from the comfort and visual acuity provided by DAILIES TOTAL1® for Astigmatism contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Randomization:
Generate a random list of 39 labels ("A" for DAILIES TOTAL1® for Astigmatism, "B" for Spherical Contact Lenses) using a computer.
Randomize the list order and apply matching coded stickers to lens packages. A designated unmasked examiner has exclusive access to the decoding key and does not partake in direct participant interaction or data handling.
Visit 1:
Confirm participant eligibility, then the unmasked examiner uses the random list to provide the coded lens package to the masked examiner.
The masked examiner fits the participant with the first set of lenses, unaware of the type.
Visit 3:
The unmasked examiner repeats Visit 1's procedure for the second set of lenses. Blinded study conditions are maintained as the masked examiner fits the second pair of lenses.
End of Study:
The unmasked examiner decodes the lens order for data analysis. This method ensures a double-blind crossover design, minimizing bias.
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identified as Asian, confirmed through both self-report and observation by the Principal Investigator (PI).
- •Age between 18 and 39 years.
- •Vertexed corrected sphere power ranging from -0.50 to -6.00 diopters (D).
- •Vertexed refractive cylinder power ranging from -0.75 to -1.50 diopters (D).
- •Best corrected visual acuity of 20/25 or better in each eye.
- •Habitual soft contact lens wear for at least 6 months and must be successfully fitted with both DT1 Spherical and Toric contact lenses.
排除标准
- •Any history of ocular pathology or surgery.
- •Presence of active ocular infection or clinically significant ocular inflammation.
- •Presence of any significant binocular vision abnormalities.
- •Use of gas-permeable contact lenses within 3 months prior to the study.
- •Pregnancy or lactation, confirmed by self-report.
结局指标
主要结局
Near high-contrast visual acuity (40cm)
时间窗: Day 4, Day 8
Assess near high-contrast visual acuity (40cm) using EyeChart PRO on an iPad.
次要结局
- Reading Acuity(Day 4, Day 8)
- Critical Print Size(Day 4, Day 8)
- Near Activity Visual Questionnaire (NAVQ)(Day 4, Day 8)
- Distance visual acuity(Day 4, Day 8)
- Maximum Reading Speed(Day 4, Day 8)
- Reading Accessibility Index(Day 4, Day 8)