Juvene IOL for Cataracts

(Nirvana Trial)

Not yet recruiting at 4 trial locations

Overseen By Vance Thompson, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: LensGen, Inc.

Must not be taking: Antidepressants, Antihistamines, Anticholinergics, others

Disqualifiers: Dry eye syndrome, Prior eye surgery, Corneal dystrophy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: Surgery and immediate post-operative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new lens implant called the Juvene® IOL (intraocular lens) for individuals who have undergone cataract surgery. The goal is to determine if this implant is safe and effective in improving vision problems, such as presbyopia (difficulty seeing things up close), after the natural lens is removed. Participants will receive either the Juvene® IOL or a standard lens for comparison. Ideal candidates have had cataract surgery and do not have dry eyes or a history of eye surgeries like LASIK. As an unphased trial, this study allows participants to contribute to innovative research that could enhance vision correction options.

Will I have to stop taking my current medications?

Yes, if you are taking medications that affect eye function, such as certain antidepressants, antihistamines, or eye-specific drugs, you may need to stop them to participate in the trial.

What prior data suggests that the Juvene IOL is safe for treating cataracts?

Research shows that the Juvene IOL is a safe choice for people with presbyopia and cataracts. Studies have found that after one year, patients experience stable vision and good results, with fewer reports of visual problems like glare and halos compared to other lens types.

Data from three years also support its safety and effectiveness. Although the Juvene IOL remains in the early stages of research, these findings suggest it is well-tolerated with few side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Juvene IOL is unique because it represents a new approach to treating cataracts. Unlike traditional intraocular lenses (IOLs) that focus on improving vision primarily at a single distance, Juvene IOL is designed with the potential to enhance vision across multiple distances, which could reduce the need for glasses post-surgery. Researchers are excited about this treatment because it offers a more versatile vision solution, potentially improving the quality of life for those undergoing cataract surgery.

What evidence suggests that the Juvene IOL is effective for cataracts?

Research shows that the Juvene IOL, which participants in this trial may receive, effectively treats cataracts and presbyopia. Studies indicate it significantly improves vision, enabling clear sight at various distances, from near to far, with an accommodative range of about 3.5 diopters. One-year data demonstrate that the Juvene IOL maintains stable and promising vision over time. Additionally, it is safe for patients requiring a new lens after cataract surgery. Overall, the Juvene IOL has strong potential to enhance vision for those with cataracts and presbyopia. ^{1 2 3 4 6}

Who Is on the Research Team?

Patrick R Casey, O.D.

Principal Investigator

LensGen, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to comply with schedule for follow-up visits

Able to comprehend and provide written informed consent

I am 22 years old or older.

Exclusion 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.

Other exclusion criteria specified in the protocol may apply.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Juvene® IOL or Tecnis® Monofocal IOL

Surgery and immediate post-operative period

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits over 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Juvene IOL

Trial Overview 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.

How Is the Trial Designed?

Group I: Investigational IOL Experimental Treatment 1 Intervention

Juvene® IOL

Group II: Control IOL Active Control 1 Intervention

Tecnis® Monofocal (ZCB00, PCB00 or DCB00)

Who Is Running the Clinical Trial?

LensGen, Inc.

Lead Sponsor

Trials

2

Recruited

120+

Citations

1. crstoday.com crstoday.com/articles/aug-2024/update-on-accommodating-iols

Update on Accommodating IOLs The 3-year data on the Juvene IOL indicate that it is a highly effective and safe option for patients with presbyopia and cataracts.

2. cataractcoach.com cataractcoach.com/2022/12/01/1669-juvene-iol-grail-study-results/

1669: Juvene IOL – Grail Study Results Monocular data showed 3.5 D of accommodative range, from approximately +1.5 D to –2 D at 20/40 or better visual acuity (Figure 1). These eyes ...

3. escrs.org escrs.org/eurotimes/one-year-results-for-juvene-iol

One-Year Results for Juvene IOL One-Year Results for Juvene IOL. 12-month data show refractive stability, promising functional outcomes. One-Year Results for Juvene IOL ...

4. ophthalmologymanagement.com ophthalmologymanagement.com/issues/2025/september/the-holy-grail-of-cataract-surgery/

The Holy Grail of Cataract Surgery Improvement in vision was noted with binocular viewing. These results showed functional vision of 20/40 from +1.5 D to -2.5 D of defocus, along ...

5. withpower.com withpower.com/trial/phase-1-cataract-7-2022-a8eb8

Juvene IOL for Cataracts (Nirvana Trial) Trial Overview The study tests the Juvene IOL's safety and effectiveness in treating aphakia (absence of the lens) and lessening presbyopia ...

6. eyeworld.org eyeworld.org/2024/current-accommodating-lenses-in-development/

Current accommodating lenses in development The Juvene lens is not currently in an active trial but the company is ramping up for a Phase 1 FDA trial. All the data published so far has been in exploratory ...