Evaluation of Clareon Vivity/Vivity Toric

Alcon

Status: Completed

Conditions: Aphakia

Treatments: Device: Clareon Vivity/Vivity Toric Extended Vision IOL; Device: Clareon Monofocal/Clareon Toric IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT05852470

ILE632-C002

Details and patient eligibility

About

This study seeks to generate clinical data from subjects previously implanted with the Clareon Vivity/Vivity Toric Intraocular Lenses (IOLs) or Clareon Monofocal/Clareon Toric IOLs. This study will assess key performance endpoints to support clinical benefits statements with model-specific data.

Full description

Both eyes of a subject must qualify for enrollment into this study. A total of 2 scheduled visits are planned. The visits include a Screening visit (Visit 0) and a visit after screening (Visit 1). The subject must be 90-180 days post second eye implant at the time of Visit 1. Visit 1 should occur 1 to 14 days after Visit 0. Subject participation is expected to last approximately 2 weeks.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Understand and sign an approved Informed Consent form
• Previously implanted in both eyes with Clareon Vivity/Clareon Vivity Toric or Clareon Monofocal/Clareon Toric IOLs for at least 3 months and up to 6 months (90 to 180 days) after second eye implant.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• History of clinically significant ocular co-morbidities that would affect surgical outcomes based on investigator expert medical opinion.
• Subjects who were targeted to monovision defined as ≥ 1.50 Diopter (D) of anisometropia.
• Clinically significant PCO (posterior capsule opacification) affecting vision.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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155 participants in 2 patient groups

Clareon Vivity/Vivity Toric

Experimental group

Description:

Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation

Treatment:

Device: Clareon Vivity/Vivity Toric Extended Vision IOL

Clareon Monofocal/Clareon Toric

Active Comparator group

Description:

Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation

Treatment:

Device: Clareon Monofocal/Clareon Toric IOL