Contralateral Claims Study of Clareon Vivity Pro

NCT07484191 · tracked via the Priya Life Science Australia tracker

Sponsor

Alcon Research

Phase

Not applicable

Started

2026-04-28

Last updated

2026-08-06

Condition(s) studied

AphakiaPresbyopia

Investigational drug(s) / intervention(s)

Clareon Vivity Pro IOLClareon Vivity IOLTECNIS PureSee IOLCataract Surgery

Clareon 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.

Clareon 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.

TECNIS 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.

Cataract Surgery: Removal of the cloudy lens, followed by implantation of the IOL

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.

Eligibility

Sex

ALL

Min age

22 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (7)

Facility	City	Region
iVision Clinic	Campsie	New South Wales
Vision Eye Institute - Chatswood	Sydney	New South Wales
Personaleyes Parramatta	Sydney	New South Wales
Wollongong Eye Specialists	Wollongong	New South Wales
Focus Vision	Woolloongabba	Queensland
Eye Surgery Associates - East Melbourne	East Melbourne	Victoria
Peninsula Eye Center	Mornington	Victoria

Other trials for the same condition

Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07484191 on ClinicalTrials.gov ↗ ← All trials in Australia