Contralateral Claims Study of Clareon Vivity Pro

N/ANot Yet RecruitingNCT07484191

Alcon Research231 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

231

Conditions

Aphakia Presbyopia

Interventions

Clareon Vivity Pro IOLDEVICE

Investigational UV-absorbing, blue-light filtering (BLF), foldable IOL that provides an extended range of vision from distance to near without increasing the incidence of visual disturbances. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject.

Clareon Vivity IOLDEVICE

Currently marketed UV-absorbing, BLF, foldable IOL that provides an extended range of vision from distance to functional near without increasing the incidence of visual disturbances. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject.

TECNIS PureSee IOLDEVICE

Currently marketed UV absorbing, violet-light filtering IOL for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia. IOLs are implantable medical devices and are intended for long term use over the lifetime of the pseudophakic subject.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Mean monocular photopic distance-corrected intermediate visual acuity (DCIVA)

Visual acuity (VA) will be assessed for each eye individually (monocular) with distance correction in place (plus or minus power) under photopic (well-lit) conditions at a distance of 66 centimeters (cm) from the spectacle plane using a visual acuity chart. VA will be measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity, with a lower logMAR value indicating better visual acuity.

Time frame: Month 1 postoperative

Central Contacts

Alcon Call Center

CONTACT

1-888-451-3937 alcon.medinfo@alcon.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.