Real-World Study of Vivity Intraocular Lenses (IOLs)

NCT ID: NCT04800016

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2024-07-31

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.

Conditions

Aphakia; Presbyopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vivity IOL

AcrySof IQ Vivity Extended Vision IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery

Group Type: EXPERIMENTAL

AcrySof IQ Vivity Extended Vision IOL

Intervention Type: DEVICE

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 surgery

Intervention Type: PROCEDURE

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

Interventions

AcrySof IQ Vivity Extended Vision IOL

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

Intervention Type: DEVICE

Cataract surgery

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

Intervention Type: PROCEDURE

Other Intervention Names

Model DFT015

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Lead, Surgical

Role: STUDY_DIRECTOR

Alcon (China) Ophthalmic Product Co., Ltd.

Locations

Hainan Bo'ao Super Hospital Co., Ltd.

Qionghai, Hainan, China

Countries

China

Other Identifiers

ILI875-P002

Identifier Type: -

Identifier Source: org_study_id