Post-Market Clinical Survey of Clareon® IOL AutonoMe™ in Japanese Subjects

Study Overview
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Brief Summary
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This purpose of this survey study is to collect and describe clinical outcomes for the intraocular lens (IOL) delivery performance of Clareon® IOL AutonoMe™ when used in daily practice.

Detailed Description
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This study will enroll subjects who underwent prior cataract surgery with phacoemulsification and were implanted with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™ automated preloaded delivery system. Subjects will be enrolled post-operatively and followed for one year.

Official Title
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Post-Market Clinical Survey of Clareon® IOL With the AutonoMe™ Automated Preloaded Delivery System With Japanese Subjects

Conditions
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Cataract

Intervention / Treatment
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* Device: Clareon® IOL AutonoMe™ automated preloaded delivery system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to comprehend and willing to sign informed consent. Prior diagnosis of age-related cataracts. Prior cataract surgery with implantation of Clareon IOL in the capsular bag by AutonoMe™. No ophthalmic disease which might affect visual acuity. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- |
| Clareon IOL AutonoMe<br>Prior implantation with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™ automated preloaded delivery system | Device: Clareon® IOL AutonoMe™ automated preloaded delivery system<br>* Disposable injector preloaded with the Clareon IOL for precise IOL insertion during cataract surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected distance visual acuity | Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart. | Up to Year 1 postoperative | 
| Intraocular lens (IOL) delivery performance | A questionnaire will be used to retrospectively evaluate the usability of AutonoME™. The investigator will respond to 8 questions pertaining to the IOL delivery performance using a 5-point scale where 1 = very good/strongly agree and 5 = very poor/strongly disagree. | Surgery day (retrospective) | 
| Difference between target refraction and postoperative subjective refraction (spherical equivalent) | Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart. Subjective refraction at best corrected distance vision will be recorded and compared with target refraction determined on day of surgery. | Up to Year 1 postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IOL, Cataract surgery, Intraocular lens, Clareon, AutonoMe