Real-World Study of Vivity Intraocular Lenses (IOLs)

Launched by ALCON RESEARCH · Mar 15, 2021

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Key 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.
• Key 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.