NCT03811249

Long Term Follow-up of the VisAbility™ Micro Insert System for Presbyopic Patients

A Prospective, Multicenter Clinical Trial of the VisAbility™ Micro Insert System for the Improvement of Near Visual Acuity in Presbyopic Subjects - Long Term Follow-up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: Refocus Group, Inc. · Industry
• Sex: All
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to obtain an additional 36 months of safety and effectiveness data from all subjects who were implanted with the VisAbility™ Micro Insert in the VIS-2014 clinical trial.

Detailed description

VIS-2014-5YR is a multicenter, observational study to evaluate the long-term safety of the VisAbility™ Micro Inserts in subjects who were implanted with the VisAbility™ Micro Insert in the VIS-2014 clinical trial. Study subjects will be examined at 36, 48, and 60 months post-operatively (based on the anniversary of their first VisAbility™ surgery) with no planned interventions.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	VisAbility™ Micro Insert	No (new) intervention will be administered during the course of this long term follow-up study. Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted in the eye(s) will be followed prospectively.

Timeline

• Start date: 2018-12-03
• Primary completion: 2021-10-01
• Completion: 2021-10-29
• First posted: 2019-01-22
• Last updated: 2023-11-18
• Results posted: 2023-11-18

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study