Contralateral Claims Study of Clareon Vivity Pro

ConditionsAphakia Presbyopia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age22+

SponsorAlcon Research

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

Clareon Vivity Pro IOL
Device
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 IOL
Device
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 IOL
Device
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.
Cataract Surgery
Procedure/Surgery
Removal of the cloudy lens, followed by implantation of the IOL

Treatment groups

231 Participants

are divided into 2 treatment groups

Group A: Clareon Vivity Pro IOL / Clareon Vivity IOL (Sub-Study B)Other 3 interventions

Group B: Clareon Vivity Pro IOL / TECNIS PureSee IOL (Sub-Study C)Other 3 interventions

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alcon Research

Lead sponsor

Source ClinicalTrials.gov

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