Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)

AcuFocus

Status: Completed

Conditions: Cataract; Presbyopia

Study type: Observational

Funder types: Industry

Identifiers

NCT05758883

SAIL-101-PAS

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).

Full description

A prospective, multi-center, open-label, single-group, post-approval follow-up study of IC-8 Apthera intraocular lens (IOL) subjects previously implanted with the IC-8 Apthera IOL in the Investigational Device Exemption (IDE) clinical study (G180075). All subjects will undergo one scheduled study visit, which is the 3-year post IC-8 Apthera IOL implantation visit. There is one study group: subjects enrolled in the US IDE study (G180075) and implanted with the IC-8 Apthera IOL.

Enrollment: 196 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Enrolled in Investigational Device Exemption (IDE) G180075 study and implanted with the IC-8 Apthera intraocular lens (IOL)
• Able to comprehend and have signed a statement of informed consent
• Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s)

Exclusion criteria

• There are no exclusion criteria for this study

Trial design

196 participants in 1 patient group

IC-8 Apthera intraocular lens (IOL) Group

Description:

Patients previously enrolled in the IC-8 Apthera IOL Investigational Device Exemption (IDE) study (G180075) and implanted with the IC-8 Apthera IOL.