NCT03314766

Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: AcuFocus, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term clinical acceptability and overall satisfaction with the IC-8 IOL at least 12 months post-IOL implantation.

Detailed description

This will be a prospective, multi-center, non-interventional study in up to 80 patients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029 at up to nine clinical sites within Europe. The purpose of this study is to demonstrate the long-term clinical acceptability and overall satisfaction in patients implanted with the IC-8 IOL. The primary study endpoint is binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients at least 12 months post-implantation. The secondary study endpoint is overall satisfaction with postoperative vision in 85% or more patients reporting either satisfied or very satisfied at least 12 months post-implantation.

Conditions

• Cataract
• Presbyopia

Interventions

Type	Name	Description
DEVICE	IC-8 IOL	Patients previously implanted with an IC-8 IOL contralaterally or bilaterally will be evaluated for their long-term visual functions and overall satisfaction at least 12 months post-implantation

Timeline

• Start date: 2017-10-20
• Primary completion: 2018-11-27
• Completion: 2018-11-27
• First posted: 2017-10-19
• Last updated: 2022-05-13

Locations

7 sites across 4 countries: Germany, Italy, Norway, Spain