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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06401551
Other study ID # ILQ137-C002-B
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 18, 2024
Est. completion date July 2025

Study information

Verified date June 2024
Source Alcon Research
Contact Alcon Call Center
Phone 888-451-3937
Email alcon.medinfo@alcon.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 79
Est. completion date July 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CPO Pro IOL
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.
CPO IOL
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.
Procedure:
Cataract Surgery
Extraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL.

Locations

Country Name City State
United States Grosinger, Spigelman & Grey Eye Surgeons, P.C. Bloomfield Hills Michigan
United States Carolina Eye Care Physicians Charleston South Carolina
United States Cincinnati Eye Institute Cincinnati Ohio
United States Houston Eye Associates Houston Texas
United States Moyes Eye Center Kansas City Missouri
United States Vision for Life Nashville Tennessee
United States The Eye Institute of Utah Salt Lake City Utah
United States Wolstan & Goldberg Eye Associates Torrance California

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Visual Acuity (VA) will be 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 will be 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. Month 2 postoperative
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