Real-World Study of Vivity Intraocular Lenses (IOLs)

Not Applicable

Withdrawn

• Conditions: Aphakia; Presbyopia
• Interventions: Device: AcrySof IQ Vivity Extended Vision IOL; Procedure: Cataract surgery

• Registration Number: NCT04800016
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-16
• Study Start: 2021-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-08-22
• Primary Completion: 2024-01
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean Monocular Distance Corrected Near Visual Acuity (DCNVA) - First Eye	Month 6 post second eye implantation	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.; .
Incidence of severe or most bothersome visual disturbances (subjects surveyed with QUVID questionnaire)	Up to Month 12 post second eye implantation	Subjects will be surveyed using the QUVID questionnaire.
Incidence of ocular adverse events	Up to Month 12 post second eye implantation	Ocular adverse events will be reported.
Mean Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) - First Eye	Month 6 post second eye implantation	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.
Incidence of secondary surgical interventions (SSIs)	Up to Month 12 post second eye implantation	Secondary surgical interventions will be reported.

Secondary Outcome Measures

Name	Time	Method
Percentage of Eyes Achieving 0.2 logMAR or better Best Corrected Distance Visual Acuity (BCDVA) - First Eye	Month 6 post second eye implantation	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.

Trial Locations

Locations (1)

Hainan Bo'ao Super Hospital Co., Ltd.; 🇨🇳 Qionghai, Hainan, China