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Recruiting NCT04187599

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

No phase Interventional Myopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Paragon CRT®100 Contact Lens.
Who it may be relevant to
Registry conditions: Myopia. Basic parameters: from 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Device 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.

Primary outcome measures

  • product effectiveness [Time frame: 1 month]
  • uncorrected visual acuity [Time frame: At baseline]
  • uncorrected visual acuity [Time frame: 1 day]
  • uncorrected visual acuity [Time frame: At 1 week]
  • uncorrected visual acuity [Time frame: At 2 weeks]
  • uncorrected visual acuity [Time frame: At 1 month]
  • uncorrected visual acuity [Time frame: At 3 months]
  • uncorrected visual acuity [Time frame: At 6 months]
  • uncorrected visual acuity [Time frame: At 9 months]
  • uncorrected visual acuity [Time frame: At 12 months/final visit]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 4 centers
  • Changsha Aier Eye Hospital — Shanghai
  • Eye & ENT Hospital of Fudan University — Shanghai
  • Tianjin Eye Hospital — Tianjin
  • The Affiliated Eye Hospital of Wenzhou Medical University — Wenzhou

Identifiers

NCT: NCT04187599 · SEC-P012019-CRT100

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗