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COMPLETEDNANCT04755231

Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population

The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.

Lead sponsor: Alcon Research•9 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Alcon Research

In this clinical study, subjects will be implanted with the PanOptix IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 14 months. This study will be conducted in China.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Able to comprehend and sign an informed consent form;
•Able to complete all study visits required in the protocol;
•Chinese; diagnosed with cataracts in both eyes;
•Planned bilateral cataract removal by routine phacoemulsification;
•Pre-operative regular corneal astigmatism of less than 1.0 diopter (D);
•Pre-operative best corrected distance visual acuity (BCDVA) worse than or equal to 0.3 LogMAR in each eye;
•Potential postoperative best corrected distance visual acuity (BCDVA) of 0.3 logMAR or better in both eyes based on the investigator expert medical opinion.

Exclusion Criteria

•Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve;
•Clinically significant corneal diseases;
•Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion;
•Previous intraocular or corneal surgery;
•Pregnancy or lactation during study or planning to be pregnant/lactating;
•Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject;
•Other planned ocular surgical procedures;
•Patients who desire monovision correction.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 10, 2023Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment181

Start dateApr 2021

Last updatedOct 10, 2023

Condition

Aphakia Presbyopia

Locations shown

Peking University People's Hospital

Beijing

Beijing Tongren Hospital Capital Medical University

Beijing

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guandong

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2023Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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