Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the long-term clinical acceptability and overall satisfaction with the IC-8 IOL at least 12 months post-IOL implantation.

Detailed Description
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This will be a prospective, multi-center, non-interventional study in up to 80 patients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029 at up to nine clinical sites within Europe. The purpose of this study is to demonstrate the long-term clinical acceptability and overall satisfaction in patients implanted with the IC-8 IOL. The primary study endpoint is binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients at least 12 months post-implantation. The secondary study endpoint is overall satisfaction with postoperative vision in 85% or more patients reporting either satisfied or very satisfied at least 12 months post-implantation.

Official Title
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Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens

Conditions
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Cataract, Presbyopia

Intervention / Treatment
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* Device: IC-8 IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients previously implanted contralaterally or bilaterally with the IC-8 IOL under the protocol ACU-P14-029 and have had the IOL implanted for a duration of at least 12 months and currently have the IC-8 IOL in the eye. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures at the study visit. Signed informed consent. Exclusion Criteria: 1. Patients who have developed systemic or ocular pathology, not related to the IOL that affected their best corrected distance visual acuity to be 0.8 decimal or worse as determined by diagnostic testing or investigator's medical judgment. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 IOL<br>Patients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029 | Device: IC-8 IOL<br>* Patients previously implanted with an IC-8 IOL contralaterally or bilaterally will be evaluated for their long-term visual functions and overall satisfaction at least 12 months post-implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TCNVA | Binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Satisfaction | Overall satisfaction with postoperative vision at least 12 months post-operatively, with an outcome of objective of 85% or more being either very satisfied or satisfied. | 12 months |