Status:
WITHDRAWN
Real-World Study of Vivity Intraocular Lenses (IOLs)
Lead Sponsor:
Alcon Research
Conditions:
Aphakia
Presbyopia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04800016
Start Date
June 1 2021
End Date
July 1 2024
Last Update
August 22 2023
Active Locations (1)
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1
Hainan Bo'ao Super Hospital Co., Ltd.
Qionghai, Hainan, China