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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
Date last updated
4/05/2022

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
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.
Trial website
https://clinicaltrials.gov/study/NCT04098367
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04098367