Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05414565




Registration number
NCT05414565
Ethics application status
Date submitted
8/06/2022
Date registered
10/06/2022

Titles & IDs
Public title
Post-Market Study of Alcon Intraocular Lenses
Scientific title
Clinical and Functional Performance of Acrysof IQ Vivity Versus Aspheric Monofocal IOLs
Secondary ID [1] 0 0
A04429
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Visual Acuity 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Vivity IOL
Treatment: Devices - Aspheric monofocal IOL

Vivity IOL - Subjects previously implanted with Vivity or Vivity toric IOL

Aspheric Monofocal IOL - Subjects previously implanted with an aspheric monofocal or monofocal toric IOL


Treatment: Devices: Vivity IOL
Commercially available extended vision IOL

Treatment: Devices: Aspheric monofocal IOL
Commercially available aspheric IOL
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Binocular photopic best-corrected distance visual acuity (BCDVA)
Timepoint [1] 0 0
At least 4 months post-operative

Eligibility
Key inclusion criteria
Key

* In good general health at the screening visit;
* Implanted in both eyes at least 4 months ago with either Vivity/Vivity toric IOL or an Alcon aspheric monofocal/monofocal toric IOL (Acrysof IQ/Clareon);
* Best Corrected Distance Visual Acuity (BCDVA) of 20/25 or better with both eyes together;
* BCDVA of 20/40 or better in each eye;

Key
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Clinically significant Posterior Capsular Opacity (PCO) as assessed via slit-lamp exam per investigator opinion;
* History of ocular surgery other than cataract surgery and Nd:YAG laser surgery;
* History of amblyopia.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/04/2024
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
School of Optometry and Vision Science, Queensland University of Technology - Kelvin Grove
Recruitment postcode(s) [1] 0 0
4059 - Kelvin Grove

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alcon Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Queensland University of Technology
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Director of Clinical Projects, 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
Jessie Hull, DrPH
Address 0 0
Country 0 0
Phone 0 0
+1 817-909-6199
Fax 0 0
Email 0 0
jessie.hull@alcon.com
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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05414565