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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 below
Select...
I am 22 years old or older.

Nirvana Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more
Secondary 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

Juvene IOL (Intraocular Lens) Clinical Trial Eligibility Overview. Trial Name: NCT05364983 — N/A
Cataract Research Study Groups: Investigational IOL, Control IOL
Cataract Clinical Trial 2023: Juvene IOL Highlights & Side Effects. Trial Name: NCT05364983 — N/A
Juvene IOL (Intraocular Lens) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05364983 — N/A
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:
  1. Hoopes Vision: < 48 hours
  2. Cleveland Eye Clinic: < 48 hours
  3. Virginia Eye Consultants: < 48 hours
Typically responds via
Phone Call
Email
Average response time
  • < 2 Days
~22 spots leftby Nov 2024