Paragon 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.
Study summary
The main objective of this post market clinical study is to evaluate the effectiveness and safety of the Paragon CRT®100 Contact Lens.
Eligibility
Sex
ALL
Min age
8 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
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
uncorrected visual acuity — 1 day Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity — At 1 week Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity — At 2 weeks Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity — At 1 month Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity — At 3 months Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity — At 6 months Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity — At 9 months Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity
uncorrected visual acuity — 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 — At Baseline Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject — At 1 day Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject — At 1 week Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject — At 2 weeks Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject — At 1 month Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject — At 3 months Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject — At 6 months Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject — At 9 months Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis
The dioptric power of subject — At 12 months/final visit 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.
The relevant important parameters of corneal topography of subject — At 1 day 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.
The relevant important parameters of corneal topography of subject — At 1 week 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.
The relevant important parameters of corneal topography of subject — At 2 weeks 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.
The relevant important parameters of corneal topography of subject — At 1 month 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.
The relevant important parameters of corneal topography of subject — At 3 months 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.
The relevant important parameters of corneal topography of subject — At 6 months 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.
The relevant important parameters of corneal topography of subject — At 9 months 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.
The relevant important parameters of corneal topography of subject — 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.
Trial sites (4)
Facility
City
Region
Status
Changsha Aier Eye Hospital
Shanghai
China
Recruiting
Eye & ENT Hospital of Fudan University
Shanghai
China
Recruiting
Tianjin Eye Hospital
Tianjin
China
Recruiting
The Affiliated Eye Hospital of Wenzhou Medical University
Wenzhou
China
Recruiting
More CooperVision International Limited (CVIL) trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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