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
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The main objective of this post market clinical study is to evaluate the effectiveness and safety of the Paragon CRT®100 Contact Lens.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
China
Changsha Aier Eye Hospital
RECRUITING
Shanghai
Eye & ENT Hospital of Fudan University
RECRUITING
Shanghai
Tianjin Eye Hospital
RECRUITING
Tianjin
The Affiliated Eye Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Contact Information
Primary
Jose Vega, OD, MSc
jvega2@coopervision.com
9256402964
Time Frame
Start Date: 2019-08-29
Estimated Completion Date: 2020-12-31
Participants
Target number of participants: 250
Treatments
Experimental: Paragon CRT®100 Contact Lens
participants will wear the Paragon CRT®100 lens with a follow up for no less than 12 months.
Related Therapeutic Areas
Sponsors
Collaborators: TigerMed
Leads: CooperVision International Limited (CVIL)