Myopia
Conditions
Brief summary
The main objective of this post market clinical study is to evaluate the effectiveness and safety of the Paragon CRT®100 Contact Lens.
Detailed description
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.
Interventions
DEVICEParagon CRT®100 Contact Lens
Paragon CRT® 100 Contact Lenses for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in nondiseased eyes.
Sponsors
TigerMed
CooperVision International Limited (CVIL)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, open label, 12 month follow up study
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 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). 2. Is willing to comply with the wear and visit schedule. 3. Is willing to participate and signed the informed consent form.
Exclusion criteria
1. Age under 8 years old 2. 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 3. Best corrected visual acuity less than 1.0D 4. Pregnant, lactating or near-pregnancy 5. The eye has the following conditions: 1. Acute and subacute inflammations or infection of the anterior segment of the eye 2. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva or eyelids, e.g. dacryocystitis, conjunctivitis, blepharitis and other inflammation, glaucoma, etc. 3. Severe insufficiency of tears (TBUT≤5s). 4. Allergy to any ingredient, such as mercury or thimerosal, in a solution which is to be used to care 5. Any active corneal infection (bacterial, fungal or viral). 6. Manifested strabismus 7. Abnormal intra-ocular pressure 8. 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.) 9. Under medications or long-term medications that lead to dry eye with clinical signs or affects vision and corneal curvature. 10. Examination result indicate any contraindication or not suitable for OrthoK lens wear 11. 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 12. Only eye fulfills inclusion criteria 13. History of any ocular operations 14. Unable to follow investigator's instruction 15. Any other condition not suitable for the study per investigator's judgement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| product effectiveness | 1 month | Effectiveness=number of eyes with both uncorrected visual acuity and dioptric power meet the effective standards/total number of eyes evaluated\*100% |
| uncorrected visual acuity | At baseline | 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 | At Baseline | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis |
| The relevant important parameters of corneal topography of subject | At Baseline | 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. |
Countries
China
Contacts
Primary ContactJose Vega, OD, MSc
Outcome results
None listed