NCT06380478

Safety and Efficacy of the Bi-Aspheric Monofocal IOL

Safety and Efficacy of the Bi-Aspheric Monofocal Intraocular Lens

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: ICARES Medicus, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 single visit in the facilities of Chang Gung University Hospital at least 3 months after the surgery. Patients will undergo a routine basic ophthalmological examination. Additionally, and retrospectively, the patients' medical records will be reviewed to obtain information on visual acuity and adverse events at postoperative visit carried out 1 month after surgery. The data corresponding to the preoperative values of corneal curvature (flat meridian, curved meridian and axes), axial length measured by biometry, visual acuity and those corresponding to the implanted IOL will also be collected from the medical records.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2024-03-05
• Primary completion: 2025-12-20
• Completion: 2025-12-31
• First posted: 2024-04-24
• Last updated: 2025-04-30

Locations

1 site across 1 country: Taiwan