Trial Review

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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
Date last updated
9/07/2024

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
The purpose of the study is to evaluate clinical and functional performance in real-world conditions in participants who have been implanted with Acrysof IQ Vivity (Extended Vision) IOLs compared with Alcon Aspheric Monofocal IOLs.
Trial website
https://clinicaltrials.gov/study/NCT05414565
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05414565