Actively Recruiting
Post-market Follow Up Study on Paragon CRT® 100 (Paflufocon D)
Led by CooperVision International Limited (CVIL) · Updated on 2019-12-05
250
Participants Needed
4
Research Sites
70 weeks
Total Duration
On this page
Sponsors
C
CooperVision International Limited (CVIL)
Lead Sponsor
T
TigerMed
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main objective of this post market clinical study is to evaluate the effectiveness and safety of the Paragon CRT®100 Contact Lens.
CONDITIONS
Official Title
Post-market Follow Up Study on Paragon CRT® 100 (Paflufocon D)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient contact lens refraction must be within the study lens parameters: spherical power between -4.00D and cylinder power within 1.50D
- Willing to comply with the lens wear and visit schedule
- Willing to participate and have signed the informed consent form
You will not qualify if you...
- Age under 8 years old
- Any ocular abnormalities, previous corneal surgery, history of eye trauma, active corneal infections, or corneal curvature outside 40.00D to 46.00D
- Best corrected visual acuity less than 1.0D
- Pregnant, lactating, or near pregnancy
- Acute or subacute inflammation or infection of the eye's anterior segment
- Any eye disease, injury, or abnormality affecting the cornea, conjunctiva, or eyelids (e.g., dacryocystitis, conjunctivitis, blepharitis, glaucoma)
- Severe tear insufficiency (TBUT 3s)
- Allergy to any solution ingredient such as mercury or thimerosal
- Any active bacterial, fungal, or viral corneal infection
- Manifested strabismus
- Abnormal intra-ocular pressure
- Systemic diseases causing low immunity or affecting corneal reshaping (e.g., sinusitis, diabetes, Down syndrome, rheumatoid arthritis, mental illness)
- Use of medications causing dry eye or affecting vision and corneal curvature
- Any contraindication or unsuitability for OrthoK lens wear based on examination
- Participation in a pharmaceutical clinical study within 3 months or other medical device study within 30 days before screening
- Only one eye meets inclusion criteria
- History of any eye surgery
- Unable to follow investigator instructions
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Changsha Aier Eye Hospital
Shanghai, China
Actively Recruiting
2
Eye & ENT Hospital of Fudan University
Shanghai, China
Actively Recruiting
3
Tianjin Eye Hospital
Tianjin, China
Actively Recruiting
4
The Affiliated Eye Hospital of Wenzhou Medical University
Wenzhou, China
Actively Recruiting
Research Team
J
Jose Vega, OD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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