Real-World Study of Vivity Intraocular Lenses (IOLs)

Real-World Study of AcrySof™ IQ Vivity Extended Vision Intraocular Lenses (IOLs)

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.

Study Overview

• Status: Withdrawn
• Conditions: Presbyopia; Aphakia
• Intervention / Treatment: Device: AcrySof IQ Vivity Extended Vision IOL; Procedure: Cataract surgery

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hainan
    • Qionghai, Hainan, China
      • Hainan Bo'ao Super Hospital Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vivity IOL; AcrySof IQ Vivity Extended Vision IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery	Device: 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.; Other Names: Model DFT015; Procedure: Cataract surgery; Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ Vivity Extended Vision IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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. .	Month 6 post second eye implantation
Incidence of ocular adverse events	Ocular adverse events will be reported.	Up to Month 12 post second eye implantation
Incidence of secondary surgical interventions (SSIs)	Secondary surgical interventions will be reported.	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.	Up to Month 12 post second eye implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 6 post second eye implantation

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Surgical, Alcon (China) Ophthalmic Product Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2021
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Cataract; Intraocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Presbyopia; Aphakia
• Other Study ID Numbers: ILI875-P002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes