Marketed Contact Lens Real World Through Focus Curve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Distance Binocular LogMAR Visual Acuity
研究概览
简要总结
This is a single-visit prospective study to establish a real world Marketed Contact Lens 'Through Focus Curve' (TFC) measurement by comparing the consistency of vision between myopes and hyperopes. 33 subjects will be enrolled (at least 15 myopes and 15 hyperopes), who are 40 years of age or older, for a 1-visit, 4-hour study for measurements to be taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •The subject must be ≥40 years of age.
- •The subjects' optimal vertexed spherical equivalent distance correction must be between -6.00 Diopters (D) and +4.00 D in each eye.
- •The subject's refractive cylinder must be ≤ -0.75 D in each eye.
- •The subject's ADD power must be in the range of +0.75 to +2.50 D in each eye.
- •The subject must have best corrected visual acuity of 20/25 or better for each eye.
- •The subject can be either a new contact lens wearer or an existing soft contact lens wearer.
排除标准
- •Currently pregnant or lactating.
- •Any ocular or systemic allergies that contraindicate contact lens wear.
- •Any ocular or systemic disease, autoimmune disease, or use of medication that contraindicates contact lens wear.
- •Any ocular abnormality that may interfere with contact lens wear.
- •Use of any ocular medication, with the exception of rewetting drops.
- •Any previous intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
- •Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) which may contraindicate contact lens wear.
- •History of herpetic keratitis.
- •Any ocular infection or inflammation.
- •Any corneal distortion or irregular cornea.
- •History of binocular vision abnormality or strabismus.
- •Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
- •History of diabetes.
- •Participant in unrelated research involving test product within 30 days before planned study visit.
结局指标
主要结局
Distance Binocular LogMAR Visual Acuity
时间窗: 4 Hr. Post Fitting
Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M\^2 ), Medium luminance ( 50 CD/M\^2 ) and High luminance ( 250 CD/M\^2 )
Intermediate Binocular LogMAR Visual Acuity
时间窗: 4 Hr. Post Fitting
intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M\^2 ), Medium luminance ( 50 CD/M\^2 ) and High luminance ( 250 CD/M\^2 )
Near Binocular LogMAR Visual Acuity
时间窗: 4 Hr. Post Fitting
Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M\^2 ), Medium luminance ( 50 CD/M\^2 ) and High luminance ( 250 CD/M\^2 )
次要结局
未报告次要终点