IC-8 Apthera IOL New Enrollment Post Approval Study

Study Overview
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Brief Summary
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The purpose of this study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation.

Detailed Description
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Prospective, multi-center, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the IC-8 Apthera IOL after Nd:YAG laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized Nd:YAG laser capsulotomy technique. All subjects will undergo approximately 6 study visits and will be followed 24 months post IC-8 Apthera IOL implantation. There is one study group: subjects previously implanted with the IC-8 Apthera IOL and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.

Official Title
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IC-8 Apthera IOL New Enrollment Post Approval Study

Conditions
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Cataract, Presbyopia, Posterior Capsule Opacification

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 22 years of age or older, any race and any gender; Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOL eye 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 visits; Clear intraocular media in both eyes; Preoperative corneal astigmatism ≤1.5 D in the IC-8 Apthera IOL eye prior to IC-8 Apthera implantation; Prior IC-8 Apthera IOL implantation in one eye and a monofocal/monofocal toric IOL in the other eye in accordance with the directions for use (DFU) for each IOL. Exclusion Criteria: Pharmacologically dilated pupil size less than 7.0 mm in the IC-8 Apthera IOL eye; Irregular astigmatism in either eye; History of retinal disease; Active or recurrent anterior segment pathology; Presence of ocular abnormalities; Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye treatment; Previous corneal or intraocular surgery, except cataract surgery; History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention; Acute, chronic or uncontrolled systemic disease that would, in the opinion of the investigator, confound the outcomes of the study; Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye; Concurrent participation or participation in any clinical trial up to 30 days prior to the first visit in the study. Subjects who plan to be traveling, relocating or otherwise unavailable to attend any of the visits

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

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 implanted with the IC-8 Apthera intraocular lens (IOL) and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment | Rates of additional Nd:YAG laser treatments in the eye implanted with the IC-8 Apthera intraocular lens (IOL) beyond the initial Nd:YAG laser treatment will be assessed through 24 months post IC-8 Apthera IOL implantation | 24 Months post IC-8 Apthera IOL Implantation | 
| Nd:YAG laser treatment outcome and/or complications | Nd:YAG laser treatment outcomes and/or complications in the eye implanted with the IC-8 Apthera intraocular lens (IOL) will be assessed through 24 months post IC-8 Apthera IOL implantation. | 24 Months post IC-8 Apthera IOL Implantation | 
| IOL related assessments | The appearance of the IC-8 Apthera intraocular lens (IOL) will be assessed through 24 months post IC-8 Apthera IOL implantation | 24 Months post IC-8 Apthera IOL implantation | 
| Rates of Secondary Surgical Interventions (SSIs) | Rates of secondary surgical interventions in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes will be assessed through 24 months post IC-8 Apthera IOL implantation | 24 Months 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 and fellow eyes will be evaluated through 24 months post IC-8 Apthera IOL implantation | 24 Months 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 and fellow eyes will be evaluated through 24 months post IC-8 Apthera IOL implantation | 24 Months post IC-8 Apthera IOL implantation | 
| Rates of subjective visual disturbances per the Quality of Vision (QoV) Questionnaire | Subjective responses to the QoV Questionnaire that assess frequency of visual disturbances (from 'never' to 'very often'), severity of those disturbances (from 'not at all' to 'severe') and bothersomeness of those disturbances (from 'not at all' to 'very') in both the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes. | 24 Months post IC-8 Apthera IOL implantation | 
| Rates of subjective visual disturbances per the Small Aperture Patient Questionnaire (SAPQ) | Subjective responses to the Small Aperture Patient Questionnaire (SAPQ) that assess frequency of visual disturbances (from 'never' to 'very often'), severity of those disturbances (from 'not at all' to 'severe') and bothersomeness of those disturbances (from 'not at all' to 'very') in both the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes. | 24 Months post IC-8 Apthera IOL implantation |