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

Not Applicable

Completed

Conditions: Aphakia

Interventions: Device: SYMFONY
Device: VIVITY
Device: AT LARA
Procedure: Cataract surgery

Registration Number: NCT04098367

Lead Sponsor: Alcon Research

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 222

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIVITY	Cataract surgery	VIVITY IOL implanted in the eye during cataract surgery
SYMFONY	Cataract surgery	SYMFONY IOL implanted in the eye during cataract surgery
SYMFONY	SYMFONY	SYMFONY IOL implanted in the eye during cataract surgery
VIVITY	VIVITY	VIVITY IOL implanted in the eye during cataract surgery
AT LARA	AT LARA	AT LARA implanted in the eye during cataract surgery
AT LARA	Cataract surgery	AT LARA implanted in the eye during cataract surgery

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)	Month 3 postoperative (Day 120-180 from second eye surgery)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3)	Month 3 postoperative (Day 120-180 from second eye surgery)	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.
Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3)	Month 3 postoperative (Day 120-180 from second eye surgery)	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.

Trial Locations

Locations (12): Alcon Investigator 8047
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Charlestown, New South Wales, Australia
Alcon Investigator 7130
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Hobart, Tasmania, Australia
Alcon Investigator 1702
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Mornington, Victoria, Australia
Alcon Investigator 3656
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Wellington, New Zealand
Alcon Investigator 8056
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Auckland, New Zealand
Alcon Investigator 8050
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Auckland, New Zealand
Alcon Investigator 8052
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Eastwood, South Australia, Australia
Alcon Investigator 6667
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Sydney, New South Wales, Australia
Alcon Investigator 7678
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Sydney, New South Wales, Australia
Alcon Investigator 8051
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Murdoch, Western Australia, Australia
Alcon Investigator 8010
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Essendon, Victoria, Australia
Alcon Investigator 7813
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Footscray, Victoria, Australia