NCT02228109已完成不适用
Multifocal Lens Centration and Its Effect on Visual Performance in a Presbyopic Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Decentration
研究概览
简要总结
The purpose of this study is to use a corneal topographer, a device that is readily available in most optometric practices, in order to determine the position of the multifocal (MF) contact lens (CL) optics in relation to the optics of the eye. The specific purpose of this study is to evaluate if there is a relationship between the positioning of the optics of the study lenses and the objective and subjective visual performance as well as participant satisfaction. The MF CL lenses will be fitted to two groups of participants (previously unsuccessful vs. currently successful MF CL wearers).
HYPOTHESES
- The measurement of the power distribution acquired from the Medmont E300 corneal topographer is effective in determining MF CL lens centration and is a predictor of MF CL success.
- There is a difference in MF CL centration, determined by corneal topography, between successful and unsuccessful MF CL wearers.
- MF CL centration, determined by corneal topography, is correlated with visual performance, determined by ocular aberrometry, measures of visual acuity and subjective satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 42 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A person is eligible for inclusion in the study if he/she:
- •Is at least 42 years of age and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Has previous experience with wearing MF CLs;
- •Is able to be successfully fitted with all study lenses;
- •Has a vertex-corrected spherical distance prescription of +6.00 to 8.00D (inclusive) in both eyes;
- •Has a spectacle cylinder ≤0.75D in both eyes;
- •Requires a reading addition of ≥+1.00D;
排除标准
- •A person will be excluded from the study if he/she:
- •Is participating in any concurrent clinical or research study;
- •Has any known active* ocular disease and/or infection;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Is pregnant, lactating or planning a pregnancy at the time of enrolment;
- •Is aphakic;
- •Has undergone refractive error surgery;
- •Has monocular best-corrected VA of worse than 20/30 in each eye;
- •Has amblyopia or strabismus;
- •Has anisometropia >2D between both eyes
- •For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
结局指标
主要结局
Decentration
时间窗: Day 1
Decentration (in mm and axis of decentration) of the multifocal contact lens optical center relative to ocular reference points (e.g. the pupil center or the line of sight), determined using difference maps produced by the Medmont E300 corneal topographer.
次要结局
- Visual Acuity (high contrast) at intermediate distance(Day 1)
- Visual Acuity (high contrast) at near(Day 1)
- Visual Acuity (low contrast) at near(Day 1)
- Ocular aberrometry(Day 1)
- Visual Acuity (high contrast) at distance(Day 1)
- Visual Acuity (low contrast) at intermediate distance(Day 1)
- Overall subjective rating of lens performance in real world tasks(Day 1)
- Visual Acuity (low contrast) at distance(Day 1)
研究者
研究点 (2)
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