Clareon Vivity/Vivity Toric for Aphakia

N/A

Waitlist Available

Research Sponsored by Alcon Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 1 (day 1-14 post screening visit, coinciding with day 90-180 post second eye implantation)

Awards & highlights

No Placebo-Only Group

Summary

This trial studies people who already have special artificial lenses in their eyes to see how well they work and their benefits. The lenses replace the eye's natural lens to help improve vision.

Eligible Conditions

Aphakia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 1 (day 1-14 post screening visit, coinciding with day 90-180 post second eye implantation)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 1 (day 1-14 post screening visit, coinciding with day 90-180 post second eye implantation)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 (day 1-14 post screening visit, coinciding with day 90-180 post second eye implantation) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant

Mean Binocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant

Secondary study objectives

Mean Binocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant

Percentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Clareon Vivity/Vivity ToricExperimental Treatment1 Intervention

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

Group II: Clareon Monofocal/Clareon ToricActive Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Clareon Vivity/Vivity Toric Extended Vision IOL

2023

N/A

~160

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