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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Nirvana Trial Summary
This trial is testing a new kind of lens to help people see better after cataract surgery.
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.Check my eligibility
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.See study design
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.
Nirvana Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
Nirvana Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best corrected distance ETDRS LogMar visual acuity
Best corrected distance ETDRS LogMar visual acuity vs control
Defocus curve testing with ETDRS chart
+2 moreSecondary outcome measures
Distance-corrected near ETDRS LogMar visual acuity
Distance-corrected near ETDRS LogMar visual acuity vs control
Nirvana 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
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 am 22 years old or older.I understand and can follow medical exam instructions.There may be additional requirements for participating in this study that are outlined in the protocol.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 understand and can follow medical exam instructions.I am 22 years old or older.You are willing and able to comply with follow-up visits.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 am 22 years old or older.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.I am 22 years old or older.There may be other requirements to be included in the study, as outlined in the study plan.
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what venues is this clinical trial currently being administered?
"This clinical trial is being conducted at 5 medical facilities, located in Norfolk, Brecksville and Sioux Falls with additional participating sites. To reduce any travel demands associated with enrollment, it can be useful to select the site that's closest to you."
Answered by AI
Are there any opportunities for individuals to take part in this clinical trial at present?
"Clinicaltrials.gov indicates that this trial, which was first uploaded on August 1st 2022 and last revised May 10th of the same year, is no longer recruiting patients for participation. Nevertheless, 149 other clinical trials are presently in need of test subjects."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Missouri
New York
Other
How old are they?
18 - 65
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Cleveland Eye Clinic
Pepose Vision Institute
Other
Virginia Eye Consultants
How many prior treatments have patients received?
1
0
What questions have other patients asked about this trial?
How quickly can I get started? How often do you need to have the visits ? I need both eyes done how much will it cost?
PatientReceived 2+ prior treatments
1. How many visits will I be making to the clinic in Utah? How long does the screening take? When will the procedure begin?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
Better results than traditional methods. Actually, the last message explains this.
PatientReceived 2+ prior treatments
I have cataracts in need lens replacement. Helped at New York Presbyterian in several trials.
PatientReceived 1 prior treatment
Looking for the latest accomodating lense for my catarract surgery.
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Hoopes Vision: < 48 hours
- Cleveland Eye Clinic: < 48 hours
- Virginia Eye Consultants: < 48 hours
Typically responds via
Phone Call
Email
Average response time
- < 2 Days
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