Assessment of 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 preference among progressive lens designs
研究概览
简要总结
Non-invasive double-blind randomised comparative study on presbyopic subjects wearing progressive lenses.
详细描述
Background and rationale:
Nowadays many different types of progressive addition lenses are available for the correction of presbyopia. Progressive addition lenses provide a more natural correction for presbyopic people due to a gradual and progressive increase of lens power from far area through the intermediate portion to the near area. However, some patients still experience adaptation problems.
The primary purpose of the study is to evaluate the preference, adaptability and visual performance of progressive lens designs (up to three designs).
Study procedures:
Each participant is required to wear all pairs of spectacles one after another, each pair for one week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- 否
入选标准
- •Subjects should be experienced progressive lens designs wearers who have worn their current prescription for at least the last one month.
- •PAL wearers with 14 mm corridor
- •Age: 45 to 70 years old
- •Best Corrected Monocular visual Acuity (decimal) both at distance and near ≥ 1.0;
- •Normal binocular vision at distance & near:
- •no strabismus on cover test,
- •no fixation disparity (Mallett aligning prism of less than 2Δ horizontally or vertically) at near
- •stereoacuity of 60" or better at near;
- •New prescription (found at visit #1) is in the range:
- •Spherical power: up to +/-6.00;
- •Cylindrical power: minus cylinder ≤ 2.5D;
- •Addition: 1.50-2.50D;
- •Difference in the power (spherical equivalent) between eyes: up to 2.0D
- •Understanding and speaking Italian or English to be able to answer questionnaires
- •Giving a written consent to participate in the study
排除标准
- •First prescription for progressive lenses.
- •Prescription found during visit#1 varies from current prescription more than 0.50D in any meridian
- •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 preference among progressive lens designs
时间窗: Entire study duration (approx. 4 weeks)
Evaluate the preference among progressive lens designs through a "First impression questionnaire" after 10-15 minutes of wearing each of the 3 PALs, a "Final satisfaction questionnaire" after 1 week of use of each of the 3 PALs and a "Comparison questionnaire" at the end of the three trial periods of all the three types of PALs.
次要结局
- Evaluate visual performance of progressive lens designs.(Entire study duration (approx. 4 weeks))
- Evaluate the adaptability of progressive lens designs.(Entire study duration (approx. 4 weeks))
研究者
Silvia Tavazzi
Professor
University of Milano Bicocca