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NCT Number: NCT04187599

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

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

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changsha Aier Eye Hospital, Shanghai, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paragon CRT®100 Contact Lens

Device

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

Primary outcomes

  1. product effectiveness

    Time frame: 1 month

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

  2. uncorrected visual acuity

    Time frame: At baseline

    Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity

  3. uncorrected visual acuity

    Time frame: 1 day

    Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity

  4. uncorrected visual acuity

    Time frame: At 1 week

    Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity

  5. uncorrected visual acuity

    Time frame: At 2 weeks

    Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity

  6. uncorrected visual acuity

    Time frame: At 1 month

    Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity

  7. uncorrected visual acuity

    Time frame: At 3 months

    Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity

  8. uncorrected visual acuity

    Time frame: At 6 months

    Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity

  9. uncorrected visual acuity

    Time frame: At 9 months

    Use standard LogMAR chart to measure the distant uncorrected visual acuity. Use 5.0 system to record LogMAR visual acuity

  10. uncorrected visual acuity

    Time frame: 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

  11. The dioptric power of subject

    Time frame: At Baseline

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

  12. The dioptric power of subject

    Time frame: At 1 day

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

  13. The dioptric power of subject

    Time frame: At 1 week

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

  14. The dioptric power of subject

    Time frame: At 2 weeks

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

  15. The dioptric power of subject

    Time frame: At 1 month

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

  16. The dioptric power of subject

    Time frame: At 3 months

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

  17. The dioptric power of subject

    Time frame: At 6 months

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

  18. The dioptric power of subject

    Time frame: At 9 months

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

  19. The dioptric power of subject

    Time frame: At 12 months/final visit

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

  20. The relevant important parameters of corneal topography of subject

    Time frame: 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.

  21. The relevant important parameters of corneal topography of subject

    Time frame: 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.

  22. The relevant important parameters of corneal topography of subject

    Time frame: 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.

  23. The relevant important parameters of corneal topography of subject

    Time frame: 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.

  24. The relevant important parameters of corneal topography of subject

    Time frame: 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.

  25. The relevant important parameters of corneal topography of subject

    Time frame: 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.

  26. The relevant important parameters of corneal topography of subject

    Time frame: 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.

  27. The relevant important parameters of corneal topography of subject

    Time frame: 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.

  28. The relevant important parameters of corneal topography of subject

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jose Vega, OD, MSc

CONTACT

[email protected]

9256402964

Sponsors and collaborators

Lead sponsor

CooperVision International Limited (CVIL)

Industry

Collaborators

  • TigerMed

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2019
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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