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

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

Detailed Description
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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.

Official Title
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Post-approval Follow-up Study of the IC-8 Apthera IOL

Conditions
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Cataract, Presbyopia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IC-8 Apthera intraocular lens (IOL) Group<br>Patients previously enrolled in the IC-8 Apthera IOL Investigational Device Exemption (IDE) study (G180075) and implanted with the IC-8 Apthera IOL. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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) | 3 years post IC-8 Apthera IOL implantation |