What side effects are associated with this type of intervention?

The most common treatment for cataracts is the surgical removal of the cloudy lens, followed by the implantation of an intraocular lens (IOL). Side effects of IOL replacement can include mild pain, inflammation, and the risk of infection. Postoperative care often involves the use of corticosteroid or nonsteroidal anti-inflammatory drug (NSAID) drops to reduce pain and inflammation. Some patients may experience complications such as macular edema, which can limit vision recovery. Additionally, there may be a need for follow-up visits to monitor for complications and ensure proper healing.

What prior FDA approvals exist?

Intraocular lenses (IOLs) have been regulated by the FDA since 1978, with significant advancements in their development and implantation over the years. These lenses are used to replace the eye's natural lens removed during cataract surgery, helping to restore vision and, in some cases, mitigate presbyopia. While specific IOLs similar to the Juvene® IOL are not detailed in the provided context, the general approval and use of various classes of IOLs have been a critical part of cataract treatment, improving visual outcomes for millions of patients.

What other types of research exist?

Promising alternatives to Juvene® IOL for cataract patients in 2024 include: 1) Extended Depth of Focus (EDOF) IOLs, which provide a continuous range of vision from near to far distances, reducing the need for glasses. 2) Trifocal IOLs, which offer clear vision at near, intermediate, and far distances, improving overall visual quality. 3) Accommodating IOLs, which mimic the eye's natural focusing ability, providing dynamic vision correction. These options are supported by recent clinical trials and advancements in IOL technology.

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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more

Secondary 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

0 / 4Eligibility criteria met

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.