Real-World Study of Vivity Intraocular Lenses (IOLs)

Study Overview
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Brief Summary
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The primary objective of this clinical study is to assess the clinical performance of the AcrySof IQ Vivity Extended Vision IOL in a Chinese population.

Detailed Description
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In this clinical study, subjects will be implanted with the AcrySof IQ Vivity Extended Vision IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 13 months. This study will be conducted in China.

Official Title
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Real-World Study of AcrySof™ IQ Vivity Extended Vision Intraocular Lenses (IOLs)

Conditions
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Aphakia, Presbyopia

Intervention / Treatment
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* Device: AcrySof IQ Vivity Extended Vision IOL
* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Able to understand and sign an approved informed consent; Willing and able to attend all scheduled study visits as required per protocol; Diagnosed with cataracts in both eyes; Pre-operative regular corneal astigmatism less than 1.0 diopter (D); Planned bilateral cataract removal by phacoemulsification. Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve; Clinically significant corneal diseases; Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion; Previous intraocular surgery history; Pregnancy or lactation during study or planning to be pregnant/lactating; Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject; Other planned ocular surgical procedures; Patients who can only undergo cataract surgery in one eye. Other protocol-specified exclusion criteria may apply.

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vivity IOL<br>AcrySof IQ Vivity Extended Vision IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery | Device: AcrySof IQ Vivity Extended Vision IOL<br>* UV and blue-light filtering extended depth of focus foldable IOL intended to provide a full range of vision from distance to functional near.<br>* Other names: Model DFT015;Procedure: Cataract surgery<br>* Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ Vivity Extended Vision IOL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) - First Eye | Intermediate visual acuity will be assessed at 66 centimeters (cm) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye. | Month 6 post second eye implantation | 
| Mean Monocular Distance Corrected Near Visual Acuity (DCNVA) - First Eye | Near visual acuity will be assessed at 40 centimeters (cm) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye. . | Month 6 post second eye implantation | 
| Incidence of ocular adverse events | Ocular adverse events will be reported. | Up to Month 12 post second eye implantation | 
| Incidence of secondary surgical interventions (SSIs) | Secondary surgical interventions will be reported. | Up to Month 12 post second eye implantation | 
| Incidence of severe or most bothersome visual disturbances (subjects surveyed with QUVID questionnaire) | Subjects will be surveyed using the QUVID questionnaire. | Up to Month 12 post second eye implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes Achieving 0.2 logMAR or better Best Corrected Distance Visual Acuity (BCDVA) - First Eye | Distance visual acuity will be assessed at 4 meters (m) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye. | Month 6 post second eye implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Intraocular lens