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Active, not recruitingNCT07484191Updated Nov 9, 2026

Contralateral Claims Study of Clareon Vivity Pro

An interventional study of Clareon Vivity Pro IOL and Clareon Vivity IOL in Aphakia and Presbyopia, sponsored by Alcon Research. Active, not recruiting at 7 sites in Australia. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study summary

The purpose of this study is to test new versions of Clareon Vivity Pro intraocular lenses (IOLs) by comparing them to currently marketed IOLs.

Read the detailed description

Two sub-studies will be conducted. In Sub-Study B, Clareon Vivity Pro will be compared to Clareon Vivity. In Sub-Study C, Clareon Vivity Pro will be compared to TECNIS PureSee.

This study will be conducted in Australia.

02

Conditions studied

  • Aphakia
  • Presbyopia

Keywords

  • Cataract
  • Eye Surgery
  • Intermediate Vision
03

In context

Aphakia

69 studies on the registry are indexed under Aphakia; 6 are open to participants now.

This study's enrollment of 165 is above the median of 103 across 52 interventional studies indexed under Aphakia.

Browse Aphakia studies →

Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Cataracts in both eyes.
  • Preoperative corneal astigmatism of less than 1.00 diopter (D) in each eye.
  • Potential postoperative best corrected visual acuity (BCDVA) of 0.2 logMAR or better in each eye in the expert medical opinion of the investigator.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Desires monovision correction.
  • Predicted post-operative residual astigmatism of more than 1D in either eye.
  • Any ocular or systemic co-morbidity that, in the investigator's medical opinion, may confound the results of this study, prohibit the completion of the study assessments, or increase the risk for the subject.
  • Other protocol-defined exclusion criteria may apply.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
165 participants (actual)

Study arms

  • Other
    Clareon Vivity Pro IOL / Clareon Vivity IOL (Sub-Study B)

    Clareon Vivity Pro IOL implanted in one eye, with Clareon Vivity IOL in the fellow eye, as randomized

    Device: Clareon Vivity Pro IOL · Device: Clareon Vivity IOL · Procedure: Cataract Surgery

  • Other
    Clareon Vivity Pro IOL / TECNIS PureSee IOL (Sub-Study C)

    Clareon Vivity Pro IOL implanted in one eye, with TECNIS PureSee IOL in the fellow eye, as randomized

    Device: Clareon Vivity Pro IOL · Device: TECNIS PureSee IOL · Procedure: Cataract Surgery

Interventions

  • DeviceClareon Vivity Pro IOL

    Investigational UV-absorbing, blue-light filtering (BLF), foldable IOL that provides an extended range of vision from distance to near without increasing the incidence of visual disturbances. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject.

  • DeviceClareon Vivity IOL

    Currently marketed UV-absorbing, BLF, foldable IOL that provides an extended range of vision from distance to functional near without increasing the incidence of visual disturbances. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject.

  • DeviceTECNIS PureSee IOL

    Currently marketed UV absorbing, violet-light filtering IOL for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject.

  • ProcedureCataract Surgery

    Removal of the cloudy lens, followed by implantation of the IOL

06

What researchers measure

Primary outcomes

  1. Mean monocular photopic distance-corrected intermediate visual acuity (DCIVA)

    Visual acuity (VA) will be assessed for each eye individually (monocular) with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 66 centimeters (cm) from the spectacle plane using a visual acuity chart. VA will be measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity.

    Time frame: Month 1 postoperative

07

Study locations

7 sites
  • iVision Clinic
    Campsie, New South Wales 2194, Australia
  • Vision Eye Institute - Chatswood
    Sydney, New South Wales 2067, Australia
  • Personaleyes Parramatta
    Sydney, New South Wales 2150, Australia
  • Wollongong Eye Specialists
    Wollongong, New South Wales 2500, Australia
  • Focus Vision
    Woolloongabba, Queensland 4102, Australia
  • Eye Surgery Associates - East Melbourne
    East Melbourne, Victoria 3002, Australia
  • Peninsula Eye Center
    Mornington, Victoria 3931, Australia
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2026 to primary completion in Oct 2026, 6 months.

Of 32 industry-sponsored interventional studies with no phase under Aphakia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 23. This study's 6 months is below that.

Counting every sponsor, half of 37 studies reached it within 17 months; a quarter within 9 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2026
First posted
Mar 20, 2026
StartActual
Apr 28, 2026
Primary completionActual
Oct 28, 2026
CompletionEst.
Feb 2027
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and date precision
2 updates, last Nov 9, 2026
Show all 2 updates
  1. Nov 9, 2026
    Minor edits only
    + 2 other changes: verification date and date precision
  2. Oct 13, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07484191
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Mar 20, 2026
Start date
Apr 28, 2026
Primary completion
Oct 28, 2026
Completion
Feb 2027 (estimated)
Last update
Nov 9, 2026

Study contacts

Clinical Trial Lead, Surgical
study director · Alcon Research, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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