Juvene IOL for Cataracts

(Nirvana Trial)

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

56 Participants Needed

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.

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 data supports the effectiveness of the Juvene IOL treatment for cataracts?

Research on similar intraocular lenses (IOLs) shows that they can improve vision at various distances and increase patient satisfaction after cataract surgery. For example, studies on other IOLs like the small aperture IC-8 and continuous transitional focus IOLs report significant improvements in vision and high patient satisfaction. ^{1 2 3 4 5}

How is the Juvene IOL treatment for cataracts different from other treatments?

The Juvene IOL treatment for cataracts is unique because it involves a specific type of intraocular lens (IOL) that may offer advantages in terms of stability and reduced risk of secondary cataracts compared to other IOLs, such as hydrophobic lenses which have shown better outcomes in preventing secondary cataracts. ^{6 7 8 9 10}

Research Team

Patrick R Casey, O.D.

Principal Investigator

LensGen, Inc.

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.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcomes With a New Continuous Range of Vision Presbyopia-Correcting Intraocular Lens. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical outcomes of cataract surgery with implantation of a continuous transitional focus intraocular lens. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Development and Validation of a Visual Symptom-Specific Patient-Reported Outcomes Instrument for Adults With Cataract Intraocular Lens Implants. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical experience with the WIOL-CF accommodative bioanalogic intraocular lens: Czech national observational registry. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Small Aperture IC-8 Extended-Depth-of-Focus Intraocular Lens in Cataract Surgery: A Systematic Review. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Pediatric cataract surgery with hydrophilic acrylic intraocular lens implantation in Nepalese children. [2022]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Results of surgical treatment for cataract with implantation of intraocular lenses in children with insulin-dependent diabetes mellitus]. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Piggybacking technique for vitreous protection during opacified intraocular lens exchange in eyes with an open posterior capsule. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Results 5 to 10 years after cataract surgery with primary IOL implantation in juvenile idiopathic arthritis-related uveitis. [2021]

10. England pubmed.ncbi.nlm.nih.gov

True rotational stability of a single-piece hydrophobic intraocular lens. [2019]