Contralateral Claims Study of Clareon Vivity Pro

Alcon

Status: Enrolling

Conditions: Presbyopia; Aphakia

Treatments: Device: Clareon Vivity IOL; Device: Clareon Vivity Pro IOL; Procedure: Cataract Surgery; Device: TECNIS PureSee IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT07484191

ILI287-C001

Details and patient eligibility

About

The purpose of this study is to test new versions of Clareon Vivity Pro intraocular lenses (IOLs) by comparing them to currently marketed IOLs.

Full description

Two sub-studies will be conducted. In Sub-Study B, Clareon Vivity Pro will be compared to Clareon Vivity. In Sub-Study C, Clareon Vivity Pro will be compared to TECNIS PureSee.

This study will be conducted in Australia and the Philippines.

Enrollment: 231 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Cataracts in both eyes.
• Preoperative corneal astigmatism of less than 1.00 diopter (D) in each eye.
• Potential postoperative best corrected visual acuity (BCDVA) of 0.2 logMAR or better in each eye in the expert medical opinion of the investigator.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Desires monovision correction.
• Predicted post-operative residual astigmatism of more than 1D in either eye.
• Any ocular or systemic co-morbidity that, in the investigator's medical opinion, may confound the results of this study, prohibit the completion of the study assessments, or increase the risk for the subject.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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231 participants in 2 patient groups

Clareon Vivity Pro IOL / Clareon Vivity IOL (Sub-Study B)

Other group

Description:

Clareon Vivity Pro IOL implanted in one eye, with Clareon Vivity IOL in the fellow eye, as randomized

Treatment:

Procedure: Cataract Surgery

Device: Clareon Vivity Pro IOL

Device: Clareon Vivity IOL

Clareon Vivity Pro IOL / TECNIS PureSee IOL (Sub-Study C)

Other group

Description:

Clareon Vivity Pro IOL implanted in one eye, with TECNIS PureSee IOL in the fellow eye, as randomized

Treatment:

Device: TECNIS PureSee IOL

Procedure: Cataract Surgery

Device: Clareon Vivity Pro IOL