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Intraocular Lens
Juvene IOL for Cataracts (Nirvana Trial)
N/A
Waitlist Available
Research Sponsored by LensGen, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be 22 years of age or older
Be older than 18 years old
Must not have
Subjects with clinically significant dry eye syndrome (DES) expected to impact postoperative visual acuity
Any corneal dystrophy that may affect visual acuity (e.g., keratoconus, pellucid corneal degeneration, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing an artificial lens called Juvene® IOL for people who have had cataract surgery. The lens replaces the removed natural lens and helps improve overall vision, including seeing things up close.
Who is the study for?
This trial is for adults over 22 who can understand and agree to the study's process, have cataracts or presbyopia, and are able to follow the visit schedule. It's not for those on certain eye-affecting meds, with past eye surgeries like LASIK, corneal diseases that affect vision, or significant dry eye syndrome.
What is being tested?
The study tests the Juvene IOL's safety and effectiveness in treating aphakia (absence of the lens) and lessening presbyopia effects after cataract surgery compared to Tecnis Monofocal lenses.
What are the potential side effects?
Potential side effects may include discomfort in the eye, visual disturbances such as glare or halos around lights, inflammation inside the eye, increased intraocular pressure or infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe dry eye syndrome that could affect my vision after surgery.
Select...
I do not have any eye conditions like keratoconus that affect my vision.
Select...
I have had eye surgery, including vision correction procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Best corrected distance ETDRS LogMar visual acuity
Best corrected distance ETDRS LogMar visual acuity vs control
Defocus curve testing with ETDRS chart
+2 moreSecondary study objectives
Distance-corrected near ETDRS LogMar visual acuity
Distance-corrected near ETDRS LogMar visual acuity vs control
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: Investigational IOLExperimental Treatment1 Intervention
Juvene® IOL
Group II: Control IOLActive Control1 Intervention
Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Juvene IOL
2018
N/A
~70
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 primary treatment for cataracts is the surgical removal of the clouded natural lens, followed by the implantation of an intraocular lens (IOL). IOLs are artificial lenses that replace the eye's natural lens, which has become opaque due to cataracts.
The mechanism of action involves the IOL focusing light onto the retina, thereby restoring clear vision. Advanced IOLs, such as the Juvene® IOL, also aim to correct presbyopia, reducing the need for reading glasses by allowing the eye to focus on both near and distant objects.
This is particularly important for cataract patients as it not only restores vision but also improves overall quality of life by addressing multiple vision issues simultaneously.
Exploring neovascular age-related macular degeneration and diabetic macular edema and advances in treatment.Consumption of glaucoma medication.
Exploring neovascular age-related macular degeneration and diabetic macular edema and advances in treatment.Consumption of glaucoma medication.
Find a Location
Who is running the clinical trial?
LensGen, Inc.Lead Sponsor
1 Previous Clinical Trials
61 Total Patients Enrolled
1 Trials studying Cataract
61 Patients Enrolled for Cataract
Patrick R Casey, O.D.Study DirectorLensGen, Inc.
1 Previous Clinical Trials
61 Total Patients Enrolled
1 Trials studying Cataract
61 Patients Enrolled for Cataract
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe dry eye syndrome that could affect my vision after surgery.I do not have any eye conditions like keratoconus that affect my vision.I am 22 years old or older.I have had eye surgery, including vision correction procedures.I understand and can follow medical exam instructions.I am currently taking medication that could affect my eyesight.I'm sorry, but "Key" is not a screening criterion. It does not provide any information about a medical condition or characteristic that would determine eligibility for a clinical trial. Please provide more context or information.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational IOL
- Group 2: Control IOL
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.
Cataract Patient Testimony for trial: Trial Name: NCT05364983 — N/A