Post-market Follow Up Study on Paragon CRT® 100 (Paflufocon D) Rigid Gas Permeable Contact Lenses for Corneal Refractive Therapy for Temporary Myopic Refractive Power Reduction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- uncorrected visual acuity
研究概览
简要总结
The main objective of this post market clinical study is to evaluate the effectiveness and safety of the Paragon CRT®100 Contact Lens.
详细描述
This clinical study has two phases: prospective and retrospective.
Prospective Phase - evaluates the post-market long-term effectiveness and safety of the Paragon CRT® 100 Contact Lenses, for temporary myopic refractive power reduction with minimum 12-month period follow-up.
Retrospective phase - evaluates the post-market long-term safety of the Paragon CRT® 100 Contact Lenses, for temporary myopic refractive power reduction.
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient contact lens refraction should fit within the available parameters of the study lenses (spherical power within -4.00D and the cylinder power within 1.50D).
- •Is willing to comply with the wear and visit schedule.
- •Is willing to participate and signed the informed consent form.
排除标准
- •Age under 8 years old
- •Any ocular abnormalities, undergone corneal surgery, or history of ocular trauma, active corneal infections (corneal inflammation), corneal curvature less than 40.00D or more than 46.00D
- •Best corrected visual acuity less than 1.0D
- •Pregnant, lactating or near-pregnancy
- •The eye has the following conditions:
- •Acute and subacute inflammations or infection of the anterior segment of the eye
- •Any eye disease, injury, or abnormality that affects the cornea, conjunctiva or eyelids, e.g. dacryocystitis, conjunctivitis, blepharitis and other inflammation, glaucoma, etc.
- •Severe insufficiency of tears (TBUT≤5s).
- •Allergy to any ingredient, such as mercury or thimerosal, in a solution which is to be used to care
- •Any active corneal infection (bacterial, fungal or viral).
- •Manifested strabismus
- •Abnormal intra-ocular pressure
- •Suffering from systemic diseases, resulting in low immunity, or affecting corneal re-shaping (such as acute and chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, mental patients, etc.)
- •Under medications or long-term medications that lead to dry eye with clinical signs or affects vision and corneal curvature.
- •Examination result indicate any contraindication or not suitable for OrthoK lens wear
- •Participated in pharmaceutical clinical study 3 months before the date of the screening or participated any other medical devices research study within 30 days of the screening
- •Only eye fulfills inclusion criteria
- •History of any ocular operations
- •Unable to follow investigator's instruction
- •Any other condition not suitable for the study per investigator's judgement
结局指标
主要结局
uncorrected visual acuity
时间窗: At 12 months/final visit
Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
The dioptric power of subject
时间窗: At 12 months/final visit
Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
product effectiveness
时间窗: 1 month
Effectiveness=number of eyes with both uncorrected visual acuity and dioptric power meet the "effective" standards/total number of eyes evaluated\*100%
The relevant important parameters of corneal topography of subject
时间窗: At 12 months/final visit
The corneal topographer is used for measurement, and the relevant parameters include: corneal curvature on the steep meridian Ks, corneal curvature on the flat meridian Kf, and corneal astigmatism.
次要结局
未报告次要终点