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Aspheric IOL
Clareon Vivity/Vivity Toric Extended Vision 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)
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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1 (day 1-14)
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 BCDVA (logMAR) at 4 m
Mean Binocular photopic DCIVA (logMAR) at 66 cm
Secondary study objectives
Mean Binocular photopic DCNVA (logMAR) at 40 cm
Proportion of subjects who respond "Never" to Question 1 of the spectacle use questionnaire (IOLSAT)
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 Toric Extended VisionExperimental Treatment1 Intervention
Previous implantation, defined as 90-180 days post second eye implantation, with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens)
Group II: Clareon/Clareon Toric AsphericActive Control1 Intervention
Previous implantation, defined as 90-180 days post second eye implantation, with Clareon/Clareon Toric Aspheric IOL (intraocular lens)
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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Who is running the clinical trial?
Alcon ResearchLead Sponsor
729 Previous Clinical Trials
128,910 Total Patients Enrolled
19 Trials studying Aphakia
6,111 Patients Enrolled for Aphakia
Clinical Trial Lead, Surgical CRDStudy DirectorAlcon Research, LLC
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have eye problems that could affect the success of surgery, according to the doctor's expert opinion.You have a condition called PCO that is affecting your vision in a significant way.There may be additional reasons why you may not be able to participate in the study, as determined by the study's specific guidelines.There may be additional requirements that need to be met as specified in the study's rules.
Research Study Groups:
This trial has the following groups:- Group 1: Clareon/Clareon Toric Aspheric
- Group 2: Clareon Vivity/Vivity Toric Extended Vision
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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