Safety and Efficacy of the Bi-Aspheric Monofocal Intraocular Lens
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY
This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subjects 18 years of age or older who have been implanted with aspicio™ monofocal intraocular lens in at least 1 eye
• Willingness to cooperate with and complete all post-operative visits
• Ability to comprehend and sign an informed consent
Locations
Other Locations
Taiwan
Chang Gung University Hospital
RECRUITING
Taoyuan District
Contact Information
Primary
Lisa Chen
lisa.phchen@gmail.com
+88636579530
Backup
Irene Shih
ishih@icaresmedicus.com
+88636579530
Time Frame
Start Date: 2024-03-05
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
aspicio Monofocal IOL
A bi-aspheric monofocal IOL is implanted through preloaded IOL Delivery System in the capsular bag in the posterior chamber of the eye during cataract surgery
Related Therapeutic Areas
Sponsors
Collaborators: AST Products, Inc.
Leads: ICARES Medicus, Inc.