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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04098367




Registration number
NCT04098367
Ethics application status
Date submitted
19/09/2019
Date registered
23/09/2019
Date last updated
1/12/2020

Titles & IDs
Public title
Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)
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
Secondary ID [1] 0 0
ILI875-P001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aphakia 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - VIVITY
Treatment: Devices - SYMFONY
Treatment: Devices - AT LARA

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 1.0 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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. The subjects will be asked, "In the past 7 days, have you experienced halos?" Subjects responding "No" will be automatically imputed as reporting "Not bothered at all." Subjects responding "Yes" will be asked, "In the past 7 days, how much have your halos bothered you?" The percentage of subjects responding, "Not bothered at all" will be calculated as (# of subjects reporting "Not bothered at all" directly or by imputation) divided by (# of subjects responding to the halos experience question, regardless of response) times 100.
Timepoint [1] 0 0
Month 3 postoperative (Day 120-180 from first eye surgery)
Secondary outcome [1] 0 0
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. The subjects will be asked, "In the past 7 days, have you experienced glare?" Subjects responding "No" will be automatically imputed as reporting "Not bothered at all." Subjects responding "Yes" will be asked, "In the past 7 days, how much has your glare bothered you?" The percentage of subjects responding, "Not bothered at all" will be calculated as (# of subjects reporting "Not bothered at all" directly or by imputation) divided by (# of subjects responding to the glare experience question, regardless of response) times 100.
Timepoint [1] 0 0
Month 3 postoperative (Day 120-180 from first eye surgery)
Secondary outcome [2] 0 0
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. The subjects will be asked, "In the past 7 days, have you experienced starbursts?" Subjects responding "No" will be automatically imputed as reporting "Not bothered at all." Subjects responding "Yes" will be asked, "In the past 7 days, how much have your starbursts bothered you?" The percentage of subjects responding, "Not bothered at all" will be calculated as (# of subjects reporting "Not bothered at all" directly or by imputation) divided by (# of subjects responding to the starbursts experience question, regardless of response) times 100.
Timepoint [2] 0 0
Month 3 postoperative (Day 120-180 from first eye surgery)

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.
Minimum age
22 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Alcon Investigative Site - Sydney
Recruitment postcode(s) [1] 0 0
2150 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alcon Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the visual disturbance profile of ACRYSOF VIVITY
Extended Vision IOL Model DFT015 with those of diffractive extended depth of focus IOLs. IOLs
are implantable medical devices intended for long-term use over the lifetime of the cataract
patient.
Trial website
https://clinicaltrials.gov/show/NCT04098367
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Alcon Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications