Assessment of Three Basic Progressive Lens Designs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Evaluate the Adaptation to Progressive Lens Designs.
研究概览
简要总结
This clinical trial investigates the differences between three different progressive addition lens designs. It is a non-invasive double-masked randomized clinical investigation. For this study, 80 participants will be recruited.
详细描述
The purpose of the study is to evaluate the preference, adaptability, and visual performance of three progressive lens designs. The difference in these lens designs is a variation of zone sizes for intermediate and near vision. The clinical trial helps manufacturers and eye care practitioners to give detailed suggestions to patients. Study participants will be experienced progressive addition lens wearers, which will be recruited by advertisements, by email, and with direct person-to-person solicitation. The study will be conducted at the Eye Care Institute at the Patient Care Center Western University of Health Sciences, Pomona, CA, 91766. For each participant, the study is completed in around two months and requires three separate visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Progressive addition lens designs are unknown to participants, investigators, and outcomes assessors.
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 45 to 70 years old.
- •Visual Acuity: far & near monocular: cc ≥ 20/20 (decimal cc ≥ 1.0)
- •Normal binocular vision (at distance & near: no strabismus on cover testing, aligning prism of less than 2Δ horizontally or vertically, stereoacuity of 2' or better at distance and near).
- •Prescription is in the range:
- •Spherical power: less than +/-6.00 D
- •Cylindrical power: less than -2.75 D
- •Addition: 1.50 D - 2.50 D
- •Difference in power (spherical equivalent) between eyes: less than 2.00 D
排除标准
- •Have never worn any progressive lens design.
- •First prescription for progressive lenses.
- •Prescription found during visit#1 varies from current prescription more than 0.50 D in any meridian.
- •Currently wearing single vision lenses with accommodative support.
- •Double vision or prismatic prescription in current glasses.
- •Known ocular disease including strabismus, any pathology, any eye surgeries that may affect visual acuity.
- •Use of systemic or ocular medications that are likely to affect vision.
- •Balance problem/vertigo problem.
- •Concurrent participation in other vision-related research.
结局指标
主要结局
Evaluate the Adaptation to Progressive Lens Designs.
时间窗: Entire study duration (approx. 4 weeks)
Evaluate the adaptation to progressive lens designs through a "Satisfaction questionnaire" after 1 week of use of each of the 3 progressive addition lenses. Scale titles: Visual Quality Scale: A 5-point scale from a minimum value of 1 to a maximum score of 5. Higher scores mean better outcomes.
次要结局
- Evaluate the Immediate Preference Among Progressive Lens Designs.(Directly after receiving the lenses (approx. 15 minutes))
- Evaluate the Preference of Progressive Lens Designs.(Entire study duration (approx. 4 weeks))