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

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

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.

Study Overview

• Status: Completed
• Conditions: Aphakia
• Intervention / Treatment: Device: VIVITY; Procedure: Cataract surgery; Device: SYMFONY; Device: AT LARA

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.

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Charlestown, New South Wales, Australia, 2290
      • Alcon Investigator 8047
    • Sydney, New South Wales, Australia, 2067
      • Alcon Investigator 6667
    • Sydney, New South Wales, Australia, 2150
      • Alcon Investigator 7678
  • South Australia
    • Eastwood, South Australia, Australia, 5063
      • Alcon Investigator 8052
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Alcon Investigator 7130
  • Victoria
    • Essendon, Victoria, Australia, 3040
      • Alcon Investigator 8010
    • Footscray, Victoria, Australia, 3011
      • Alcon Investigator 7813
    • Mornington, Victoria, Australia, 3931
      • Alcon Investigator 1702
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Alcon Investigator 8051
• New Zealand
  • Auckland, New Zealand, 1050
    • Alcon Investigator 8056
  • Auckland, New Zealand
    • Alcon Investigator 8050
  • Wellington, New Zealand, 6011
    • Alcon Investigator 3656

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VIVITY; VIVITY IOL implanted in the eye during cataract surgery	Device: VIVITY; 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; Other Names: AcrySof™ IQ Vivity™ Extended Vision IOL Model DFT015; Procedure: Cataract surgery; Cataract removal by routine small incision surgery
Active Comparator: SYMFONY; SYMFONY IOL implanted in the eye during cataract surgery	Procedure: Cataract surgery; Cataract removal by routine small incision surgery; Device: SYMFONY; 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; Other Names: TECNIS Symfony® Extended Range of Vision IOL Model ZXR00
Active Comparator: AT LARA; AT LARA implanted in the eye during cataract surgery	Procedure: Cataract surgery; Cataract removal by routine small incision surgery; Device: AT LARA; 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; Other Names: AT LARA® extended depth of focus IOL Model 829MP

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Surgical, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Actual): May 3, 2021
• Study Completion (Actual): July 22, 2021

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: IOL; Intraocular lens; Presbyopia; Cataracts; Extracapsular cataract extraction; Extended depth of focus; Visual disturbances
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Aphakia
• Other Study ID Numbers: ILI875-P001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes