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Intraocular Lens
Clareon Vivity IOLs with Mini-Monovision for Aphakia
N/A
Recruiting
Research Sponsored by Debbie S. Kuo, MD
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 3 month post-surgery
Awards & highlights
Study Summary
This trial looks at the safety & effectiveness of IOLs for cataract surgery with mini-monovision.
Who is the study for?
This trial is for adults with bilateral age-related cataracts who need both eyes operated on. They should have a potential post-op vision of 20/25 or better, require specific IOL powers, and be able to undergo two surgeries within 21 days using Clareon Vivity lenses. People with irregular astigmatism, eye diseases like glaucoma or macular degeneration, previous eye surgeries, or other conditions affecting vision are not eligible.Check my eligibility
What is being tested?
The study is examining the effectiveness of Clareon Vivity and Clareon Vivity Toric intraocular lenses in achieving mini-monovision after cataract surgery. The dominant eye will be set for clear distance vision (emmetropia) while the non-dominant eye will be slightly nearsighted (-0.50).See study design
What are the potential side effects?
While the description doesn't specify side effects, typical ones for similar procedures may include discomfort, redness in the eyes, temporary blurred vision or visual disturbances such as glare and halos around lights.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 month post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 month post-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Binocular distance is target-corrected visual acuity (VA) at near 40cm.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mini-Monovision ArmExperimental Treatment1 Intervention
Bilateral implantation of Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision.
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Who is running the clinical trial?
Alcon ResearchIndustry Sponsor
703 Previous Clinical Trials
124,441 Total Patients Enrolled
16 Trials studying Aphakia
5,847 Patients Enrolled for Aphakia
Debbie S. Kuo, MDLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had eye surgery.I have cataracts in both eyes and plan to get Clareon Vivity implants within 21 days.I do not have eye or related diseases that significantly affect my vision.I have eye conditions like irregular astigmatism, corneal dystrophies, or pupil abnormalities.I have had complications during or after surgery.I have cataracts in both eyes and plan to get Clareon Vivity implants within 21 days.
Research Study Groups:
This trial has the following groups:- Group 1: Mini-Monovision Arm
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.
Aphakia Patient Testimony for trial: Trial Name: NCT05821101 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the overall size of the population participating in this research effort?
"Affirmative. Clinicaltrials.gov contains information to suggest that this study is actively seeking participants after being initially posted on April 6th 2023 and recently updated on the twentieth of April, 2023. 30 individuals must be recruited from 1 location in order to complete the trial's requirements."
Answered by AI
Is this research still enrolling participants?
"Reportedly, the clinical trial is looking for volunteers. The original posting of this investigation was on April 6th 2023 with modifications completed just 14 days later."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
Palo Alto Medical Foundation
Why did patients apply to this trial?
My cataracts have progressed to the point that I need lens replacement. I am supposed to have cataract surgery according to my doctor and it was diagnosed in November 2022. I am concerned that I get the best possible lenses to help with my vision.
PatientReceived 2+ prior treatments
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