NCT05377515

Evaluation of Visual Outcomes in Patients With Complex Corneas Implanted With the IC-8 IOL

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: AcuFocus, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal.

Detailed description

This will be a prospective, non-randomized, single-arm, single-visit, single-center, clinical study in up to 40 patients previously contralaterally implanted with the IC-8 IOL at one clinical site in Singapore. The purpose of this study is to to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal. The co-primary study endpoints are monocular uncorrected distance, intermediate, near visual acuities.

Conditions

• Cataract
• Presbyopia
• Irregular; Contour of Cornea

Timeline

• Start date: 2022-02-10
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2022-05-17
• Last updated: 2023-05-10

Locations

1 site across 1 country: Singapore