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NCT Number: NCT07484191

Contralateral Claims Study of Clareon Vivity Pro

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

Recruiting

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Key information

Conditions

Aphakia Cataract Eye Diseases Lens Diseases Presbyopia Refractive Errors

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

iVision Clinic, Campsie, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clareon Vivity Pro IOL

Device

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

Device

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

Device

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

Procedure

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

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alcon Call Center

CONTACT

[email protected]

1-888-451-3937

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 20, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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