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

Refocus Group

Status: Completed

Conditions: Presbyopia

Treatments: Device: VisAbility™ Micro Insert

Study type: Interventional

Funder types: Industry

Identifiers

NCT03811249

VIS-2014-5YR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 287 patients

Sex: All

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who were implanted with the VisAbility™ Micro Insert in Protocol VIS-2014

Exclusion criteria

• N/A

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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287 participants in 1 patient group

Implantation-Non-randomized

Experimental group

Description:

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 for an additional 36 month period to measure long term safety and effectiveness outcomes.

Treatment:

Device: VisAbility™ Micro Insert