Next-Generation Intraocular Lens for Cataract

Recruiting at 9 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

243 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new artificial lens called TECNIS IOL, Model DEN00V for people who need lens replacement due to cataracts. The new lens aims to improve vision by replacing the cloudy natural lens with a clear one. The TECNIS IOL family has a history of being used in cataract surgeries to improve visual outcomes, with various models like TECNIS Synergy and TECNIS ZMB00 being evaluated for their effectiveness.

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 data supports the effectiveness of the treatment Aspheric Monofocal IOL, TECNIS® Next-Generation Intraocular Lens, Model DEN00V?

The Tecnis intraocular lenses, like the Tecnis Symfony and Tecnis Multifocal, have been shown to improve vision quality by reducing visual distortions and enhancing focus range, which suggests that the TECNIS® Next-Generation Intraocular Lens may also offer similar benefits in improving vision after cataract surgery. ^{1 2 3 4 5}

Is the TECNIS® Next-Generation Intraocular Lens safe for humans?

The TECNIS intraocular lenses, including various models, have been evaluated for safety in clinical trials, showing they are generally safe for use in humans during cataract surgery. ^{1 6 7 8 9}

What makes the TECNIS® Next-Generation Intraocular Lens unique for cataract treatment?

The TECNIS® Next-Generation Intraocular Lens is unique because it incorporates an aspheric, modified anterior prolate design with a diffractive multifocal lens, which aims to minimize spherical aberration (distortion of vision) and improve the range of focus, potentially reducing the need for glasses after cataract surgery. ^{1 2 3 10 11}

Research Team

Johnson & Johnson Surgical Vision, Inc. Clinical Trial

Principal Investigator

Johnson & Johnson Surgical Vision, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Clinical performance of a hybrid presbyopia-correcting intraocular lens in patients undergoing cataract surgery in a multicenter trial. [2023]

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

Patient acceptability of the Tecnis multifocal intraocular lens. [2021]

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

Visual outcomes and patient satisfaction after implantation of a presbyopia-correcting intraocular lens that combines extended depth-of-focus and multifocal profiles. [2021]

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

Clinical outcomes of a new extended range of vision intraocular lens: International Multicenter Concerto Study. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Comparison of higher-order aberrations and contrast sensitivity between Tecnis Z9001 and CeeOn 911A intraocular lenses: a prospective randomized study. [2006]

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

Evaluation of the aspheric tecnis multifocal intraocular lens: one-year results from the first cohort of the food and drug administration clinical trial. [2022]

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

Clinical outcomes of TECNIS toric intraocular lens implantation after cataract removal in patients with corneal astigmatism. [2022]

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

Visual Outcomes, Quality of Vision, Patient Satisfaction and Spectacle Independence After Bilateral Implantation of the Synergy™ Intraocular Lens. [2023]

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

Clinical Evaluation of a Novel Preloaded Intraocular Lens Delivery System During Routine Cataract Surgery. [2022]

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

Clinical evaluation of a multifocal aspheric diffractive intraocular lens. [2022]

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

Visual performance of the Tecnis one-piece lens ZCB00. [2021]