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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Myopia

Intervention / Treatment
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* Device: Paragon CRT®100 Contact Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, open label, 12 month follow up study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paragon CRT®100 Contact Lens<br>participants will wear the Paragon CRT®100 lens with a follow up for no less than 12 months. | Device: Paragon CRT®100 Contact Lens<br>* Paragon CRT® 100 Contact Lenses for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in nondiseased eyes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| product effectiveness | Effectiveness=number of eyes with both uncorrected visual acuity and dioptric power meet the effective standards/total number of eyes evaluated*100% | 1 month | 
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At baseline | 
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | 1 day | 
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At 1 week | 
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At 2 weeks | 
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At 1 month | 
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At 3 months | 
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At 6 months | 
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At 9 months | 
| uncorrected visual acuity | Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity | At 12 months/final visit | 
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At Baseline | 
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 1 day | 
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 1 week | 
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 2 weeks | 
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 1 month | 
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 3 months | 
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 6 months | 
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 9 months | 
| The dioptric power of subject | Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis | At 12 months/final visit | 
| The relevant important parameters of corneal topography of subject | 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. | At Baseline | 
| The relevant important parameters of corneal topography of subject | 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. | At 1 day | 
| The relevant important parameters of corneal topography of subject | 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. | At 1 week | 
| The relevant important parameters of corneal topography of subject | 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. | At 2 weeks | 
| The relevant important parameters of corneal topography of subject | 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. | At 1 month | 
| The relevant important parameters of corneal topography of subject | 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. | At 3 months | 
| The relevant important parameters of corneal topography of subject | 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. | At 6 months | 
| The relevant important parameters of corneal topography of subject | 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. | At 9 months | 
| The relevant important parameters of corneal topography of subject | 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. | At 12 months/final visit |