Post-market Follow Up Study on Paragon CRT® 100 (Paflufocon D)

Exclusion Criteria16

• 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