Real-World Study of Vivity Intraocular Lenses (IOLs)

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04800016
• Other study ID #: ILI875-P002
• Status: Withdrawn
• Phase: N/A
• Start date: June 2021
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphakia
• Presbyopia

Intervention

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.

Procedure:
• Cataract surgery
Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ Vivity Extended Vision IOL

Locations

Country	Name	City	State
China	Hainan Bo'ao Super Hospital Co., Ltd.	Qionghai	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Incidence of ocular adverse events	Ocular adverse events will be reported.	Up to Month 12 post second eye implantation
Primary	Incidence of secondary surgical interventions (SSIs)	Secondary surgical interventions will be reported.	Up to Month 12 post second eye implantation
Primary	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	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