Real-World Study of Vivity Intraocular Lenses (IOLs)

Alcon Research

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Aphakia Presbyopia

Interventions

AcrySof IQ Vivity Extended Vision IOLDEVICE

UV and blue-light filtering extended depth of focus foldable IOL intended to provide a full range of vision from distance to functional near.

Cataract surgeryPROCEDURE

Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ Vivity Extended Vision IOL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hainan Bo'ao Super Hospital Co., Ltd.

Qionghai, Hainan, China

Outcomes

Primary Outcomes

Mean Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) - First Eye

Intermediate visual acuity will be assessed at 66 centimeters (cm) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye.

Time frame: Month 6 post second eye implantation

Mean Monocular Distance Corrected Near Visual Acuity (DCNVA) - First Eye

Near visual acuity will be assessed at 40 centimeters (cm) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye. .

Time frame: Month 6 post second eye implantation

Incidence of ocular adverse events

Ocular adverse events will be reported.

Time frame: Up to Month 12 post second eye implantation

Incidence of secondary surgical interventions (SSIs)

Secondary surgical interventions will be reported.

Time frame: Up to Month 12 post second eye implantation

Incidence of severe or most bothersome visual disturbances (subjects surveyed with QUVID questionnaire)

Subjects will be surveyed using the QUVID questionnaire.

Time frame: Up to Month 12 post second eye implantation

Secondary Outcomes

Percentage of Eyes Achieving 0.2 logMAR or better Best Corrected Distance Visual Acuity (BCDVA) - First Eye

Distance visual acuity will be assessed at 4 meters (m) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye.

Time frame: Month 6 post second eye implantation

Data from ClinicalTrials.gov

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