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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04098367
Ethics application status
Date submitted
19/09/2019
Date registered
23/09/2019

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
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
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)
Timepoint [1] 0 0
Month 3 postoperative (Day 120-180 from second eye surgery)
Secondary outcome [1] 0 0
Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3)
Timepoint [1] 0 0
Month 3 postoperative (Day 120-180 from second eye surgery)
Secondary outcome [2] 0 0
Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3)
Timepoint [2] 0 0
Month 3 postoperative (Day 120-180 from second 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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/07/2021
Sample size
Target
Accrual to date
Final
222
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Alcon Investigator 8047 - Charlestown
Recruitment hospital [2] 0 0
Alcon Investigator 6667 - Sydney
Recruitment hospital [3] 0 0
Alcon Investigator 7678 - Sydney
Recruitment hospital [4] 0 0
Alcon Investigator 8052 - Eastwood
Recruitment hospital [5] 0 0
Alcon Investigator 7130 - Hobart
Recruitment hospital [6] 0 0
Alcon Investigator 8010 - Essendon
Recruitment hospital [7] 0 0
Alcon Investigator 7813 - Footscray
Recruitment hospital [8] 0 0
Alcon Investigator 1702 - Mornington
Recruitment hospital [9] 0 0
Alcon Investigator 8051 - Murdoch
Recruitment postcode(s) [1] 0 0
2290 - Charlestown
Recruitment postcode(s) [2] 0 0
2067 - Sydney
Recruitment postcode(s) [3] 0 0
2150 - Sydney
Recruitment postcode(s) [4] 0 0
5063 - Eastwood
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
3040 - Essendon
Recruitment postcode(s) [7] 0 0
3011 - Footscray
Recruitment postcode(s) [8] 0 0
3931 - Mornington
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Lead, Surgical
Address 0 0
Alcon Research, LLC
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04098367