Next-Generation Intraocular Lens for Cataract

No longer recruiting at 10 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johnson & Johnson Surgical Vision, Inc.

Must not be taking: Tamsulosin, Silodosin

Disqualifiers: Diabetes, Macular degeneration, Glaucoma, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of lens, the TECNIS® Next-Generation Intraocular Lens, Model DEN00V, to improve vision after cataract surgery, comparing it to a standard lens. The goal is to determine if the new lens provides better vision quality and safety. Participants should have cataracts in both eyes and difficulty seeing clearly, even with glasses. Those who have had other eye surgeries or have certain eye conditions might not qualify. This trial offers an opportunity to potentially improve vision with the latest lens technology. As an unphased trial, it allows participants to experience cutting-edge lens technology and contribute to advancements in cataract treatment.

Will I have to stop taking my current medications?

The trial requires that you do not use certain medications that may affect vision, such as tamsulosin or silodosin, during the 6-month study. If you are taking these or other medications that could impact your vision, you may need to stop them to participate.

What prior data suggests that this intraocular lens is safe for cataract patients?

Research shows that TECNIS intraocular lenses, such as the Model DEN00V, have undergone safety testing in various studies. These studies indicate that the lenses are generally safe. Patients report comfort, with no major safety issues. While minor side effects may occur, they are common with lens implants and usually manageable. For those considering joining a trial with this lens, existing research supports its safety for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

The TECNIS® Next-Generation Intraocular Lens (IOL), Model DEN00V, is unique because it aims to enhance vision quality for cataract patients by incorporating advanced optics that may improve contrast sensitivity and reduce visual disturbances like halos and glare. Unlike standard IOLs that primarily focus on correcting basic vision issues, this new lens design seeks to provide a more comprehensive visual experience, potentially increasing patient satisfaction with post-surgery results. Researchers are excited about this lens because it represents a significant step forward in IOL technology, offering the possibility of improved visual outcomes and quality of life for those undergoing cataract surgery.

What evidence suggests that the TECNIS® Next-Generation Intraocular Lens might be an effective treatment for cataracts?

Research has shown that the TECNIS Next-Generation Intraocular Lens (IOL), which participants in this trial may receive, helps reduce astigmatism, a common cause of blurry vision. One study found that patients experienced an average astigmatism reduction of 74.53%, resulting in clearer vision. This lens is designed to improve vision for people with cataracts, a condition that blurs vision. Compared to standard lenses, the TECNIS lens aims to provide better focus and visual quality, making it a promising choice for those considering cataract surgery. Participants in this trial may also receive a control lens device for standard comparison. ^{1 2 3 5 6}

Who Is on the Research Team?

Johnson & Johnson Surgical Vision, Inc. Clinical Trial

Principal Investigator

Johnson & Johnson Surgical Vision, Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 22 with cataracts in both eyes, who can see at most 20/40 Snellen but could potentially improve to 20/30 after surgery. They must have normal corneal shape, clear eyes except for the cataract, and be able to follow study procedures and answer questions in English.

Inclusion Criteria

≤ 1.0 D of preoperative keratometric astigmatism

Corneal astigmatism: Normal corneal topography

I am at least 22 years old.

Exclusion Criteria

Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D

My pupils do not react normally or are abnormally shaped.

Pregnancy, planned pregnancy, presently lactating or another condition associated with hormonal fluctuation that could lead to refractive changes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TECNIS IOL, Model DEN00V or control IOL Model ZCB00/DCB00

Immediate post-surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• Aspheric Monofocal IOL
• TECNIS® Next-Generation Intraocular Lens, Model DEN00V

Trial Overview

The study compares a new intraocular lens (IOL), Model DEN00V, against an established aspheric monofocal IOL. Participants will receive one of these lenses during cataract surgery. The trial is randomized and masked meaning neither the participants nor the researchers know who receives which lens.

How Is the Trial Designed?

Group I: investigational Lens Device Experimental Treatment 1 Intervention

investigational IOL Model DEN00V

Group II: Control Lens Device Active Control 1 Intervention

control IOL Model ZCB00/DCB00

Who Is Running the Clinical Trial?

Johnson & Johnson Surgical Vision, Inc.

Lead Sponsor

Trials

40

Recruited

8,800+

Published Research Related to This Trial

The TECNIS toric intraocular lenses (IOLs) significantly reduced ocular astigmatism, with a mean reduction of 74.53% in patients requiring lower cylinder correction (0.75 to 1.50 diopters) compared to only 31.61% in those with standard IOLs, indicating their superior efficacy.

A high percentage of patients achieved excellent uncorrected distance visual acuity (UCDVA), with 43.6% of those with TECNIS toric IOLs reaching 20/20 vision or better, demonstrating both safety and effectiveness in treating cataract patients with corneal astigmatism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of TECNIS toric intraocular lens implantation after cataract removal in patients with corneal astigmatism. Waltz, KL., Featherstone, K., Tsai, L., et al.[2022]

The Tecnis(®) Multifocal Intraocular Lens is designed to enhance vision quality and reduce spherical aberration, aiming to provide patients with a broader range of focus after cataract surgery.

This lens design reflects the growing demand for presbyopia-correcting solutions, highlighting its potential to help patients achieve spectacle independence, which is a key goal in modern cataract surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient acceptability of the Tecnis multifocal intraocular lens. Sood, P., Woodward, MA.[2021]

Citations

1.

withpower.com

withpower.com/trial/phase-cataract-9-2022-f8de9

Next-Generation Intraocular Lens for Cataract

The TECNIS toric intraocular lenses (IOLs) significantly reduced ocular astigmatism, with a mean reduction of 74.53% in patients requiring lower cylinder ...

2.

ctv.veeva.com

ctv.veeva.com/study/clinical-investigation-of-the-tecnis-r-next-generation-intraocular-lens-model-den00v

Clinical Investigation of the TECNIS® Next-Generation ...

Prospective, multicenter, bilateral, masked (sponsor, subject and evaluator), randomized clinical trial to evaluate the safety and effectiveness of the TECNIS ...

3.

useye.com

useye.com/clinical-studies/

US Eye Clinical Studies: Advancing Vision Care

Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens (BRAVO). Status: Completed. Learn more.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06377514?term=AREA%5BConditionSearch%5D(Cataract)&rank=9

Clinical Investigation of the TECNIS® Next-Generation ...

A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two ...

5.

withpower.com

withpower.com/trial/phase-cataract-5-2024-cf4b0

TECNIS® Intraocular Lens for Cataracts · Info for Participants

The TECNIS toric intraocular lenses (IOLs) significantly reduced ocular astigmatism, with a mean reduction of 74.53% in patients requiring lower cylinder ...

6.

centerforsight.net

centerforsight.net/clinical-studies/

Clinical Studies | Center For Sight

RayOne EMV Toric IOL Clinical Study, Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V, RxSight: RxSight Light Adjustable ...