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

CooperVision International Limited (CVIL)250 enrolled

Overview

The main objective of this post market clinical study is to evaluate the effectiveness and safety of the Paragon CRT®100 Contact Lens.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Myopia

Interventions

Paragon CRT®100 Contact LensDEVICE

Paragon CRT® 100 Contact Lenses for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in nondiseased eyes.

Eligibility

Sex: ALLMin age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Changsha Aier Eye Hospital

Shanghai, China

RECRUITING

Eye & ENT Hospital of Fudan University

Shanghai, China

RECRUITING

Tianjin Eye Hospital

Tianjin, China

RECRUITING

Outcomes

Primary Outcomes

product effectiveness

Effectiveness=number of eyes with both uncorrected visual acuity and dioptric power meet the "effective" standards/total number of eyes evaluated\*100%

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Central Contacts

Jose Vega, OD, MSc

CONTACT

9256402964 jvega2@coopervision.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

The Affiliated Eye Hospital of Wenzhou Medical University

Wenzhou, China

RECRUITING

Time frame: 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

Time frame: 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

Time frame: At 12 months/final visit

The dioptric power of subject

Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis

Time frame: At Baseline

The dioptric power of subject

Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis

Time frame: At 1 day

The dioptric power of subject

Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis

Time frame: At 1 week

The dioptric power of subject

Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis

Time frame: At 2 weeks

The dioptric power of subject

Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis

Time frame: At 1 month

The dioptric power of subject

Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis

Time frame: At 3 months

The dioptric power of subject

Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis

Time frame: At 6 months

The dioptric power of subject

Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis

Time frame: At 9 months

The dioptric power of subject

Measure dioptric power (subjective dioptric power): include spherical power, cylindrical power, and cylindrical axis

Time frame: At 12 months/final visit