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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
Study Summary
This trial looks at the long-term safety & performance of 4 types of IOLs (eye implants) to help improve vision.
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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to year 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to year 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Find a Location
Who is running the clinical trial?
Alcon ResearchLead Sponsor
704 Previous Clinical Trials
124,031 Total Patients Enrolled
44 Trials studying Astigmatism
7,964 Patients Enrolled for Astigmatism
Clinical Trial Lead, SurgicalStudy DirectorAlcon Research, LLC
3 Previous Clinical Trials
342 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had specific lens implants in both eyes 3-6 months ago.I've had eye surgery to correct vision after getting a Clareon lens implant.There may be other qualifications necessary for inclusion.
Research Study Groups:
This trial has the following groups:- Group 1: Clareon PanOptix IOL - Non Toric
- Group 2: Clareon Vivity IOL - Toric
- Group 3: Clareon PanOptix IOL - Toric
- Group 4: Clareon Vivity IOL - Non Toric
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any availability slots for this clinical trial at the present moment?
"This research project, initially posted on June 1st 2023 and last updated on March 22nd 2023, is not presently seeking participants. Nonetheless there are 73 other exploratory studies that require volunteers at the moment."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
What site did they apply to?
Eye Surgeons of CNY
Tulsa Ophthalmology
Why did patients apply to this trial?
I would like to have more than just cataracts corrected during surgery but don’t want halos, reduced contrast and sharpness. The options for this trial look very promising.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How many and how long are screening visits? Once approved how long before getting started? I’ve read a lot of information online but what information do you recommend reading or viewing?
PatientReceived no prior treatments
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