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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• Changsha Aier Eye Hospital — Шанхай
• Eye & ENT Hospital of Fudan University — Шанхай
• Tianjin Eye Hospital — Тяньцзинь
• The Affiliated Eye Hospital of Wenzhou Medical University — Wenzhou

Идентификаторы

NCT: NCT04187599 · SEC-P012019-CRT100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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