Contralateral Claims Study of Clareon Vivity Pro
1 other identifier
interventional
165
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2026
CompletedFirst Posted
Study publicly available on registry
March 20, 2026
CompletedStudy Start
First participant enrolled
April 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
ExpectedAugust 6, 2026
August 1, 2026
5 months
March 16, 2026
August 4, 2026
Conditions
Keywords
Outcome Measures
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.
Month 1 postoperative
Study Arms (2)
Clareon Vivity Pro IOL / Clareon Vivity IOL (Sub-Study B)
OTHERClareon Vivity Pro IOL implanted in one eye, with Clareon Vivity IOL in the fellow eye, as randomized
Clareon Vivity Pro IOL / TECNIS PureSee IOL (Sub-Study C)
OTHERClareon Vivity Pro IOL implanted in one eye, with TECNIS PureSee IOL in the fellow eye, as randomized
Interventions
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.
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.
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.
Removal of the cloudy lens, followed by implantation of the IOL
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (7)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead, Surgical
Alcon Research, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2026
First Posted
March 20, 2026
Study Start
April 28, 2026
Primary Completion
October 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
August 6, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share