Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses Over a Range of Refractive Astigmatism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Visual Acuity
研究概览
简要总结
The aim of this work is to undertake a range of vision-related measures with soft toric contact lenses soft spherical contact lenses and spectacle lens correction across a range of levels of astigmatism.
详细描述
This will be a randomised, crossover, partially subject-masked (for contact lenses only), non-dispensing study, controlled by cross-comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will only be eligible for the study if:
- •They are of legal age between 18 and 40 years.
- •They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They are current wearers of any soft contact lens (i.e. have worn lenses in the last six months).
- •They have refractive ocular astigmatism between 0.00DC and -1.50DC in one or both eyes.
- •They have a spherical component to their ocular refractive error between 0.00 and - 6.00 DS.
- •They could attain at least 0.10 logMAR distance high contrast visual acuity in one eye with the study lenses within the available power range.
- •They can be fitted satisfactorily with both lens types.
- •They own an acceptable pair of spectacles.
- •They agree not to participate in other clinical research for the duration of this study.
排除标准
- •Subjects will not be eligible to take part in the study if:
- •They have an ocular disorder which would normally contra-indicate contact lens wear.
- •They have a systemic disorder which would normally contra-indicate contact lens wear.
- •They are using any topical medication such as eye drops or ointment.
- •They have had corneal refractive surgery.
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- •They are pregnant or breastfeeding.
- •They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- •They have an amblyopic eye, in which case only dominant eye will be assessed for that subject.
- •They have an infectious disease (e.g. hepatitis), any immunosuppressive disease (e.g. HIV) or diabetes.
- •They have a history of severe allergic reaction or anaphylaxis.
- •They have taken part in any other contact lens clinical trial or research, within two weeks prior to starting this study.
研究组 & 干预措施
Soft Toric Custom Made contact lenses
Subjects will be randomized to wear Soft Toric custom made contact lenses for 30 minutes in one eye with other eye patched.
干预措施: Soft Toric Custom Made Contact lens (Device)
Soft Toric Custom Made contact lenses
Subjects will be randomized to wear Soft Toric custom made contact lenses for 30 minutes in one eye with other eye patched.
干预措施: Soft Spherical Contact Lenses (Device)
Soft Toric Custom Made contact lenses
Subjects will be randomized to wear Soft Toric custom made contact lenses for 30 minutes in one eye with other eye patched.
干预措施: Spectacle Correction (Device)
Soft Spherical Contact Lenses
Subjects will be randomized to wear soft spherical contact lens for 30 minutes in one eye with other eye patched
干预措施: Soft Toric Custom Made Contact lens (Device)
Soft Spherical Contact Lenses
Subjects will be randomized to wear soft spherical contact lens for 30 minutes in one eye with other eye patched
干预措施: Soft Spherical Contact Lenses (Device)
Soft Spherical Contact Lenses
Subjects will be randomized to wear soft spherical contact lens for 30 minutes in one eye with other eye patched
干预措施: Spectacle Correction (Device)
Spectacle Correction
Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
干预措施: Soft Toric Custom Made Contact lens (Device)
Spectacle Correction
Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
干预措施: Soft Spherical Contact Lenses (Device)
Spectacle Correction
Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
干预措施: Spectacle Correction (Device)
结局指标
主要结局
Visual Acuity
时间窗: After 30 minutes of dispense (High Contrast VA)
Visual acuity was assessed using logMAR for each intervention.
Visual Acuity
时间窗: Baseline with low contrast VA
Visual acuity was assessed using logMAR for each intervention.
Visual Acuity
时间窗: After 30 minutes of dispense (Low Contrast VA)
Visual acuity was assessed using logMAR for each intervention.
Visual Acuity
时间窗: Baseline with High contrast VA
Visual acuity was assessed using logMAR for each intervention.
次要结局
- Slit Lamp Biomicroscopy Findings - Corneal Staining(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Corneal Oedema(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Conjunctival Redness(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Limbal Redness(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Conjunctival Staining(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Conjunctival Redness(Entrance (Prior to wear of study lens))
- Slit Lamp Biomicroscopy Findings - Limbal Redness(Entrance (Prior to wear of study lens))
- Slit Lamp Biomicroscopy Findings - Corneal Staining(Entrance (Prior to wear of study lens))
- Slit Lamp Biomicroscopy Findings - Conjunctival Staining(Entrance (Prior to wear of study lens))
- Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis(Entrance (Prior to wear of study lens))
- Slit Lamp Biomicroscopy Findings - Corneal Oedema(Entrance (Prior to wear of study lens))