Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)

Study Overview
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Brief Summary
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The purpose of this study is to compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the cataract patient.

Detailed Description
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A total of 10 scheduled visits are planned. The visits include a screening visit, 2 operative visits, and 7 postoperative visits. Both eyes will be implanted. The second eye implant will occur within 7-21 days of the first eye implant. The primary endpoint data will be collected at the Month 3 visit. Individual subject participation is expected to last 6-7 months. This study will be conducted in Australia and New Zealand.

Official Title
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A Prospective, Randomized, Controlled, Multi-Center Clinical Investigation of the AcrySof IQ Vivity Extended Vision IOL vs. TECNIS Symfony and AT LARA Extended Depth of Focus IOLs

Conditions
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Aphakia

Intervention / Treatment
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* Device: VIVITY
* Device: SYMFONY
* Device: AT LARA
* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned cataract removal in both eyes. Willing and able to complete all required postoperative visits. Able to understand, read and write English and willing to sign an approved statement of informed consent. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Women of childbearing potential, pregnant, intend to become pregnant, breastfeeding. Any eye condition, disease or pathology, other than cataract, that is expected to reduce postoperative best corrected distance visual acuity, as specified in the protocol. Ocular trauma or ocular surface disease that would affect study measurements. Patients who desire monovision correction. Other protocol-specified exclusion criteria may apply.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIVITY<br>VIVITY IOL implanted in the eye during cataract surgery | Device: VIVITY<br>* Extended vision intraocular lens intended for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed by extracapsular cataract extraction<br>* Other names: AcrySof™ IQ Vivity™ Extended Vision IOL Model DFT015;Procedure: Cataract surgery<br>* Cataract removal by routine small incision surgery<br>|
| Active Comparator: SYMFONY<br>SYMFONY IOL implanted in the eye during cataract surgery | Device: SYMFONY<br>* Extended range of vision intraocular lens indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed<br>* Other names: TECNIS Symfony® Extended Range of Vision IOL Model ZXR00;Procedure: Cataract surgery<br>* Cataract removal by routine small incision surgery<br>|
| Active Comparator: AT LARA<br>AT LARA implanted in the eye during cataract surgery | Device: AT LARA<br>* Extended depth of focus intraocular lens indicated for implantation for the visual correction of aphakia in patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction<br>* Other names: AT LARA® extended depth of focus IOL Model 829MP;Procedure: Cataract surgery<br>* Cataract removal by routine small incision surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3) | QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about vision-related experiences. A halo is a circular spreading of light around a light source, such as car headlights at night. Question 2 of QUVID asked the subject, In the past 7 days, have you experienced halos? Subjects responding No were automatically imputed as reporting, 0=Not bothered at all. Subjects responding Yes were then asked Question 2.3: In the past 7 days, how much have your halos bothered you? Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100. | Month 3 postoperative (Day 120-180 from second eye surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3) | Glare is a wide dispersion of light, such as an intensified reflection of the sun off a glass building. Question 3 of QUVID asked the subject, In the past 7 days, have you experienced glare? Subjects responding No were automatically imputed as reporting, 0=Not bothered at all. Subjects responding Yes were then asked Question 3.3: In the past 7 days, how much has your glare bothered you? Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100. | Month 3 postoperative (Day 120-180 from second eye surgery) | 
| Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3) | A starburst is a star-shaped spreading of light around a light source, such as car headlights at night. Question 1 of QUVID asked the subject, In the past 7 days, have you experienced starbursts? Subjects responding No were automatically imputed as reporting, 0=Not bothered at all. Subjects responding Yes were then asked Question 1.3: In the past 7 days, how much have your starbursts bothered you? Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100. | Month 3 postoperative (Day 120-180 from second eye surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataracts, Extracapsular cataract extraction, IOL, Extended depth of focus, Visual disturbances, Presbyopia, Intraocular lens