Next-Generation Intraocular Lens for Cataract
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.12345
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.12356
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the TECNIS IOL, Model DEN00V or control IOL Model ZCB00/DCB00
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aspheric Monofocal IOL
- TECNIS® Next-Generation Intraocular Lens, Model DEN00V
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johnson & Johnson Surgical Vision, Inc.
Lead Sponsor