Juvene IOL for Cataracts
(Nirvana Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: LensGen, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

+2 more

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.

+2 more

Participant Groups

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.

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)