TECNIS® Intraocular Lens for Cataracts

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Johnson & Johnson Surgical Vision, Inc.

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications, but you cannot participate if you are taking medication that may affect vision.

What data supports the idea that TECNIS® Intraocular Lens for Cataracts is an effective treatment?

The available research shows that the TECNIS Eyhance intraocular lens (IOL) is effective in improving vision for cataract patients. One study compared the TECNIS Eyhance lens to a conventional monofocal lens and found that patients with the TECNIS Eyhance lens had better visual outcomes and were more satisfied. Another study focused on the TECNIS Eyhance Toric II lens, which is designed to stay stable in the eye, and found it remained stable over three months. These findings suggest that the TECNIS lenses provide better vision and stability compared to some other options.

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What safety data is available for the TECNIS Intraocular Lens for cataracts?

The safety data for the TECNIS Intraocular Lens, including versions like TECNIS Eyhance and TECNIS Eyhance Toric II, has been evaluated in several studies. These studies include assessments of rotational stability, safety, and effectiveness of the lenses, as well as postoperative visual performance and ocular aberrations. The research indicates that these lenses are designed to provide stable and effective outcomes for patients with cataracts, including those with corneal astigmatism.

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Is the TECNIS® Next-Generation Intraocular Lens a promising treatment for cataracts?

Yes, the TECNIS® Next-Generation Intraocular Lens is a promising treatment for cataracts. It aims to improve vision by reducing the need for glasses and enhancing focus. The lens is designed to be stable and effective, especially for people with astigmatism, which is a common eye condition that causes blurred vision.

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Eligibility Criteria

This trial is for English-speaking adults at least 22 years old with cataracts in both eyes who can sign consent and attend follow-up visits. It's not suitable for those unable to comply with the study procedures or complete questionnaires.

Inclusion Criteria

Patient must understand, read, and write English to complete informed consent and questionnaires

Patient must sign the written informed consent

I am at least 22 years old.

Exclusion Criteria

Patient currently participating in any other clinical study or have participated in a clinical study during the last 30 days

I have uncontrolled eye pressure.

I am on medication that could affect my eyesight.

Participant Groups

The study compares two types of intraocular lenses (IOLs) used in cataract surgery: a control lens (Model DCB00) and a test lens (Model DEN00V). Participants will be randomly assigned to receive one of these lenses, in a masked setup where the sponsor, subjects, and evaluators do not know which lens is given.

Group I: Test IOL Experimental Treatment 1 Intervention

DEN00V

Group II: Control IOL Active Control 1 Intervention

DCB00

TECNIS® Next-Generation Intraocular Lens is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as TECNIS Eyhance for:

• Cataract correction

🇺🇸 Approved in United States as TECNIS Eyhance for:

• Cataract correction

🇨🇦 Approved in Canada as TECNIS Eyhance for:

• Cataract correction

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Berkeley Eye Center Houston, TX

Harvard Eye Associates Laguna Hills, CA

Jones Eye Center Sioux City, IA

Parkhurst NuVision San Antonio, TX

More Trial Locations

Who Is Running the Clinical Trial?

Johnson & Johnson Surgical Vision, Inc. Lead Sponsor

References

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

Rotational stability of a new toric intraocular lens with an advanced optical profile. [2023] To examine the rotational stability of a new toric intraocular lens (IOL), the TECNIS Eyhance Toric II, over a course of 3 months.

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

Evaluation of Postoperative Total Ocular Aberrations After Bilateral Implantation of Monofocal IOL with Extended Depth of Focus in Phacoemulsification. [2023] To evaluate postoperative visual performance and total ocular aberration in cataract patients after implantation of the TECNIS Eyhance™ intraocular lens (IOL).

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

Comparative evaluation of visual outcomes after bilateral implantation of an advanced or conventional monofocal intraocular lens. [2022] To assess the clinical outcomes and patient satisfaction of the Tecnis Eyhance, an advanced monofocal intraocular lens (IOL), compared to a conventional monofocal IOL.

4. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of new monofocal innovative and standard monofocal intraocular lens after phacoemulsification. [2021] Label="PURPOSE" NlmCategory="OBJECTIVE">To evaluate the early findings of new monofocal intraocular lens (Tecnis® Eyhance) in comparison with standard monofocal intraocular lens (Tecnis® 1-piece) in patients who underwent cataract surgery.

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

Patient acceptability of the Tecnis multifocal intraocular lens. [2021] Cataract surgery has evolved. The goal of the surgeon includes both restoration of vision and refinement of vision. Patients' desire for spectacle independence has driven the market for presbyopia-correcting cataract surgery and development of novel intraocular lens (IOL) designs. The Tecnis(®) Multifocal Intraocular Lens incorporates an aspheric, modified anterior prolate IOL with a diffractive multifocal lens design. The design aims to minimize spherical aberration and improve range of focus. The purpose of this review is to assess patient acceptability of the Tecnis(®) multifocal intraocular lens.

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

Comparing Visual Performance and Subjective Outcomes with an Enhanced Monofocal Intraocular Lens When Targeted for Emmetropia or Monovision. [2023] To evaluate relative visual performance and subjective outcomes after implantation of the TECNIS Eyhance™ intraocular lens (IOL) targeted for bilateral emmetropia or monovision.

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] To evaluate safety and effectiveness of the TECNIS toric intraocular lenses (IOLs).

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

Effects of Modified Haptics on Surgical Outcomes and Rotational Stability of Toric Intraocular Lens Implantation. [2023] To assess the rotational stability of a new toric intraocular lens (IOL), TECNIS toric II (toric II), which is a modified version of the TECNIS toric IOL (toric I) with frosted haptics (Johnson & Johnson).