NCT05574270

Clinical Investigation of a Small Aperture Extended Depth of Focus Intraocular Lens in Patients With Complex Corneas

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: AcuFocus, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the clinical outcomes of the IC-8 IOL implanted in patients with complex corneas after crystalline lens removal.

Detailed description

This is a prospective, multi-center, open-label, non-randomized, single-arm clinical investigation with planned postoperative follow-up of 4-6 months. The monocular and binocular performance of the subjects will be evaluated. The objective of this study is to evaluate the clinical outcomes of the IC-8 IOL implanted in patients with complex corneas after crystalline lens removal. The co-primary effectiveness endpoints are monocular uncorrected distance, intermediate, and near visual acuities at 4-6 Months postoperative. The primary safety endpoint is best-corrected distance visual acuity at 4-6 Months postoperative. The secondary safety endpoint is photopic and mesopic contrast sensitivity at 4-6 Months postoperative.

Conditions

• Cataract
• Presbyopia
• Irregular Astigmatism

Interventions

Type	Name	Description
DEVICE	IC-8 Intraocular Lens (IOL)	A small aperture extended depth of focus hydrophobic acrylic intraocular lens.

Timeline

• Start date: 2022-07-12
• Primary completion: 2024-11-28
• Completion: 2024-11-28
• First posted: 2022-10-10
• Last updated: 2024-12-19

Locations

2 sites across 2 countries: Philippines, Singapore