Real-World Study of Vivity Intraocular Lenses (IOLs)

Alcon

Status

Withdrawn

Conditions

Presbyopia

Aphakia

Treatments

Procedure: Cataract surgery

Device: AcrySof IQ Vivity Extended Vision IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT04800016

ILI875-P002

Details and patient eligibility

About

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.

Full 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 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.