Clinical trial NCT04800016: Real-World Study of Vivity Intraocular Lenses (IOLs)
Official title: Real-World Study of AcrySof™ IQ Vivity Extended Vision Intraocular Lenses (IOLs)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Aphakia
Presbyopia
Keywords: Cataract
Intraocular lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Mean Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) - First Eye
timeFrame: Month 6 post second eye implantation
measure: Mean Monocular Distance Corrected Near Visual Acuity (DCNVA) - First Eye
timeFrame: Month 6 post second eye implantation
measure: Incidence of ocular adverse events
timeFrame: Up to Month 12 post second eye implantation
measure: Incidence of secondary surgical interventions (SSIs)
timeFrame: Up to Month 12 post second eye implantation
measure: Incidence of severe or most bothersome visual disturbances (subjects surveyed with QUVID questionnaire)
timeFrame: Up to Month 12 post second eye implantation
Secondary outcomes:
measure: Percentage of Eyes Achieving 0.2 logMAR or better Best Corrected Distance Visual Acuity (BCDVA) - First Eye
timeFrame: Month 6 post second eye implantation
Other outcomes:
Locations:
city: Qionghai
country: China
facility: Hainan Bo'ao Super Hospital Co., Ltd.
state: Hainan
Study officials:
affiliation: Alcon (China) Ophthalmic Product Co., Ltd.
name: Clinical Trial Lead, Surgical
role: STUDY_DIRECTOR
References: