Visual Performance With Clareon® Vivity® Intraocular Lenses (IOLs)

Alcon

Status: Enrolling

Conditions: Astigmatism

Treatments: Device: Clareon Vivity Extended Vision IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT06784063

ILE632-C003

Details and patient eligibility

About

The purpose of this study is to generate clinical data to quantify the impact of residual astigmatism on the overall visual performance during distance, intermediate, and near viewing in patients implanted with Clareon Vivity IOLs.

Full description

This single visit study is designed to help understand how vision is affected if the eye still has astigmatism after cataract surgery. Participants will be individuals who have already undergone cataract surgery and received a Clareon Vivity IOL in both eyes at least 4 months prior to study enrollment. During the study visit, trial lenses (glass lenses that are used during an eye exam) will be used to temporarily create the effect of astigmatism on the eye.

Enrollment: 60 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to understand and sign an Institution Review Board-approved informed consent form;
• Willing and able to attend all scheduled study visits as required by the protocol;
• Implanted with study IOLs in both eyes at least 4 months prior to study participation;
• BCDVA of 0 logMAR or better in each eye.

Exclusion criteria

• Residual astigmatism greater than or equal to 1.00 D;
• Clinically significant ocular conditions as specified in the protocol;
• History of ocular surgeries other than limbal relaxing incisions
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Clareon Vivity/Vivity Toric

Experimental group

Description:

Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOLs, with previous implantation defined as at least 4 months prior to study participation.

Treatment:

Device: Clareon Vivity Extended Vision IOL