Real-World Study of Vivity Intraocular Lenses (IOLs)

  • End date
    Jul 29, 2024
  • participants needed
  • sponsor
    Alcon Research
Updated on 4 October 2022
intraocular lens implantation


The primary objective of this clinical study is to assess the clinical performance of the AcrySof IQ Vivity Extended Vision IOL in a Chinese population.


In this clinical study, subjects will be implanted with the AcrySof IQ Vivity Extended Vision 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 13 months. This study will be conducted in China.

Condition Aphakia, Presbyopia
Treatment cataract surgery, AcrySof IQ Vivity Extended Vision IOL
Clinical Study IdentifierNCT04800016
SponsorAlcon Research
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Able to understand and sign an approved informed consent
Willing and able to attend all scheduled study visits as required per protocol
Diagnosed with cataracts in both eyes
Pre-operative regular corneal astigmatism less than 1.0 diopter (D)
Planned bilateral cataract removal by phacoemulsification
Other protocol-specified inclusion criteria may apply

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 surgery history
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 can only undergo cataract surgery in one eye
Other protocol-specified exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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