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

NCT04187599 | Recruiting DMC FDA Device

• 1 other identifier: SEC-P012019-CRT100
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (28)

• 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

Study Arms (1)

Paragon CRT®100 Contact Lens

EXPERIMENTAL

participants will wear the Paragon CRT®100 lens with a follow up for no less than 12 months.

Device: Paragon CRT®100 Contact Lens

Interventions

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.

Paragon CRT®100 Contact Lens

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CooperVision International Limited (CVIL): lead
• TigerMed: collaborator

Study Sites (4)

Changsha Aier Eye Hospital

Shanghai, China

RECRUITING

Eye & ENT Hospital of Fudan University

Shanghai, China

RECRUITING

Tianjin Eye Hospital

Tianjin, China

RECRUITING

The Affiliated Eye Hospital of Wenzhou Medical University

Wenzhou, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Jiang Jun, MD

  The Affiliated Eye Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Qu Xiao Mei, MD

  Eye & ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Yang Zhi Kuan, MD

  Changsha Aier Eye Hospital

  PRINCIPAL INVESTIGATOR

• Li Li Hua, MD

  Tianjin Eye Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Vega, OD, MSc

CONTACT

9256402964; jvega2@coopervision.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open label, 12 month follow up study

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 5, 2019
• Study Start: August 29, 2019
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: December 5, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)