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OpenTrials
Completed

NCT Number: NCT06401551

Clareon PanOptix Pro vs. Clareon PanOptix - Study B

The purpose of this study is to evaluate the safety and effectiveness of Clareon™ PanOptix™ Pro Trifocal Intraocular Lens (IOL) compared to Clareon™ PanOptix™ Trifocal IOL.

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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

Wolstan & Goldberg Eye Associates, Torrance, California, United States

Loading trial locations.

About this study

Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 6 months. The primary endpoint will be assessed at the Month 2 follow-up visit. Both eyes of a subject must qualify for enrollment into this study.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Understand and sign an ethics committee-approved informed consent form;
  • Willing and able to attend all scheduled study visits as required by the protocol;
  • Planned cataract surgery (both eyes);
  • Preoperative corneal astigmatism less that 1.00 diopter in each eye.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Women of childbearing potential if currently pregnant, intend to become pregnant during the study, or are breastfeeding;
  • Ocular conditions as specified in the protocol;
  • Subjects who desire monovision correction.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

CPO Pro IOL

Device

Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining comparable distance visual acuity. The Clareon™ PanOptix™ Pro Trifocal IOL is designed to enhance distance image quality by reducing chromatic aberration.

Other names: Clareon PanOptix Pro Trifocal IOL, Model PAYWT0

CPO IOL

Device

Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining distance visual acuity.

Other names: Clareon PanOptix, Model CNWTT0

cataract surgery

Procedure

Extraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL

Primary outcomes

  1. Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)

    Time frame: Month 2 postoperative

    Visual Acuity (VA) was assessed for each eye individually using Early Treatment Diabetic Retinopathy Study (ETDRS) reading charts at a distance of 4 meters from the subject under photopic (well-lit) conditions with correction in place. BCDVA was measured in logarithm Minimum Angle of Resolution (logMAR). LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision), with lower scores indicating better vision.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 6, 2024
Registry last updated
Jun 2, 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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