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

AcuFocus, Inc.196 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

196

Conditions

Cataract Presbyopia

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (20)

Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center

Tucson, Arizona, United States

Empire Eye & Laser Center

Outcomes

Primary Outcomes

Rates of secondary surgical interventions (SSIs)

Rates of secondary surgical interventions in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit

Time frame: 3 years post IC-8 Apthera IOL implantation

Rates of other serious adverse events

Rates of other serious adverse events in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit

Time frame: 3 years post IC-8 Apthera IOL implantation

Rates of ocular adverse events

Rates of ocular adverse events in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit

Time frame: 3 years post IC-8 Apthera IOL implantation

Rates of subjective visual disturbances

Rates of subjective visual disturbances will be assessed using responses to patient Reported Outcomes (PRO) and responses to non-directed question(s)

Time frame: 3 years post IC-8 Apthera IOL implantation

Data from ClinicalTrials.gov

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