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Intraocular Lens

IOL Implants for Vision Improvement

N/A
Recruiting
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 up to year 3
Awards & highlights

Summary

This trial is studying the safety and performance of special artificial lenses used in cataract surgery. The study focuses on patients who have already received these lenses. These lenses help improve vision by replacing the eye's cloudy natural lens and focusing light correctly onto the retina.

Who is the study for?
This study is for people who have had bilateral implantation of Clareon Vivity or PanOptix lenses, with or without astigmatism correction (Toric), between 3-6 months ago. Participants must be able to sign a consent form and have their medical history available. Pregnant individuals, those in other studies, or those who've had corneal surgery after lens implantation cannot join.
What is being tested?
The trial aims to assess the long-term safety and effectiveness of two types of intraocular lenses: Clareon Vivity and PanOptix, including versions designed for astigmatism (Toric). It's a follow-up study focusing on patients who already received these implants.
What are the potential side effects?
While specific side effects are not listed here, typical risks associated with intraocular lens implants can include visual disturbances like glare and halos, eye inflammation or infection, bleeding inside the eye, increased eye pressure, and retinal detachment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to year 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to year 3 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 Best Corrected Distance Visual Acuity (BCDVA) at each prospective visit
Rate of Adverse Events
Rate of Device Deficiencies

Trial Design

4Treatment groups
Experimental Treatment
Group I: Clareon Vivity IOL - ToricExperimental Treatment1 Intervention
Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon Vivity IOL.
Group II: Clareon Vivity IOL - Non ToricExperimental Treatment1 Intervention
Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon Vivity IOL.
Group III: Clareon PanOptix IOL - ToricExperimental Treatment1 Intervention
Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon PanOptix IOL.
Group IV: Clareon PanOptix IOL - Non ToricExperimental Treatment1 Intervention
Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon PanOptix IOL.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for astigmatism, particularly those involving Extended Depth of Focus (EDOF) and Multifocal Intraocular Lenses (IOLs) like Clareon Vivity, Vivity Toric, Clareon PanOptix, and PanOptix Toric, work by correcting the irregular curvature of the cornea or lens that causes blurred vision. EDOF lenses extend the range of clear vision, reducing dependency on glasses by providing a continuous range of focus from near to far distances. Multifocal lenses, on the other hand, have multiple zones for different focal points, allowing for clear vision at various distances. These mechanisms are crucial for astigmatism patients as they address the specific refractive errors, improving overall visual acuity and quality of life by reducing the need for corrective eyewear.

Find a Location

Who is running the clinical trial?

Alcon ResearchLead Sponsor
728 Previous Clinical Trials
128,574 Total Patients Enrolled
49 Trials studying Astigmatism
8,624 Patients Enrolled for Astigmatism
Clinical Trial Lead, SurgicalStudy DirectorAlcon Research, LLC
3 Previous Clinical Trials
343 Total Patients Enrolled

Media Library

Clareon PanOptix Trifocal IOL - Non Toric (Intraocular Lens) Clinical Trial Eligibility Overview. Trial Name: NCT05796453 — N/A
Astigmatism Research Study Groups: Clareon Vivity IOL - Toric, Clareon PanOptix IOL - Non Toric, Clareon PanOptix IOL - Toric, Clareon Vivity IOL - Non Toric
Astigmatism Clinical Trial 2023: Clareon PanOptix Trifocal IOL - Non Toric Highlights & Side Effects. Trial Name: NCT05796453 — N/A
Clareon PanOptix Trifocal IOL - Non Toric (Intraocular Lens) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05796453 — N/A
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