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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04098367
Registration number
NCT04098367
Ethics application status
Date submitted
19/09/2019
Date registered
23/09/2019
Date last updated
4/05/2022
Titles & IDs
Public title
Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)
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Scientific title
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
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Secondary ID [1]
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ILI875-P001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aphakia
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - VIVITY
Treatment: Devices - SYMFONY
Treatment: Devices - AT LARA
Treatment: Surgery - Cataract surgery
Experimental: VIVITY - VIVITY IOL implanted in the eye during cataract surgery
Active Comparator: SYMFONY - SYMFONY IOL implanted in the eye during cataract surgery
Active Comparator: AT LARA - AT LARA implanted in the eye during cataract surgery
Treatment: Devices: 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
Treatment: Devices: 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
Treatment: Devices: 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
Treatment: Surgery: Cataract surgery
Cataract removal by routine small incision surgery
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)
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Assessment method [1]
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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.
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Timepoint [1]
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Month 3 postoperative (Day 120-180 from second eye surgery)
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Secondary outcome [1]
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Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3)
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Assessment method [1]
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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.
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Timepoint [1]
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Month 3 postoperative (Day 120-180 from second eye surgery)
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Secondary outcome [2]
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Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3)
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Assessment method [2]
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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.
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Timepoint [2]
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Month 3 postoperative (Day 120-180 from second eye surgery)
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Eligibility
Key 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.
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Minimum age
22
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/11/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/07/2021
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Sample size
Target
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Accrual to date
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Final
222
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Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Alcon Investigator 8047 - Charlestown
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Recruitment hospital [2]
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Alcon Investigator 6667 - Sydney
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Recruitment hospital [3]
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Alcon Investigator 7678 - Sydney
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Recruitment hospital [4]
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Alcon Investigator 8052 - Eastwood
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Recruitment hospital [5]
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Alcon Investigator 7130 - Hobart
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Recruitment hospital [6]
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Alcon Investigator 8010 - Essendon
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Recruitment hospital [7]
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Alcon Investigator 7813 - Footscray
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Recruitment hospital [8]
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Alcon Investigator 1702 - Mornington
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Recruitment hospital [9]
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Alcon Investigator 8051 - Murdoch
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Recruitment postcode(s) [1]
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2290 - Charlestown
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Recruitment postcode(s) [2]
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2067 - Sydney
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Recruitment postcode(s) [3]
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2150 - Sydney
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Recruitment postcode(s) [4]
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5063 - Eastwood
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Recruitment postcode(s) [5]
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7000 - Hobart
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Recruitment postcode(s) [6]
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3040 - Essendon
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Recruitment postcode(s) [7]
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3011 - Footscray
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Recruitment postcode(s) [8]
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3931 - Mornington
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Recruitment postcode(s) [9]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Wellington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Alcon Research
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04098367
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trial Lead, Surgical
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Address
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Alcon Research, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04098367
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