What side effects are associated with this type of intervention?

Common treatments for cataracts, particularly involving intraocular lenses (IOLs) like the TECNIS IOL, Model DEN00V, can have side effects such as mild pain, inflammation, and the risk of macular edema. Postoperative care often includes the use of corticosteroid or NSAID eye drops to manage these symptoms. Follow-up visits are crucial to monitor for complications and ensure proper healing. While these treatments generally improve visual acuity and reduce spherical aberration, patients should be aware of the potential need for ongoing medication and follow-up care.

What prior FDA approvals exist?

The FDA has approved several intraocular lenses (IOLs) for the treatment of cataracts, aimed at improving visual acuity and reducing spherical aberration. Notable examples include the TECNIS family of IOLs, which are designed to enhance image quality by correcting spherical aberrations. These lenses, like the TECNIS IOL, Model DEN00V, are aspheric monofocal lenses that provide better contrast sensitivity and overall visual performance compared to traditional spherical IOLs. Other similar FDA-approved IOLs include the AcrySof IQ and the Bausch + Lomb enVista, both of which also focus on reducing spherical aberration to improve postoperative visual outcomes.

What other types of research exist?

Promising alternatives to the TECNIS IOL, Model DEN00V for cataract patients in 2024 include: 1) Alcon's AcrySof IQ PanOptix Trifocal IOL, which provides enhanced near, intermediate, and distance vision. 2) Johnson & Johnson's Symfony Extended Depth of Focus (EDOF) IOL, designed to improve visual acuity across a range of distances while reducing the need for glasses. 3) Bausch + Lomb's enVista MX60E IOL, which offers improved clarity and reduced dysphotopsia. These options represent advancements in IOL technology aimed at improving patient outcomes and satisfaction.

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Intraocular Lens

Next-Generation Intraocular Lens for Cataract

N/A

Waitlist Available

Research Sponsored by Johnson & Johnson Surgical Vision, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified here but generally may include discomfort, redness or swelling around the eye, blurred vision temporarily after implantation, increased risk of retinal detachment or endophthalmitis (eye inflammation).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MONOCULAR PHOTOPIC BCDVA AT 4 M

MONOCULAR PHOTOPIC DCIVA AT 66 CM

Secondary Surgical Interventions (SSIs)

Secondary study objectives

MONOCULAR, PHOTOPIC DCNVA AT 40 CM

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: investigational Lens DeviceExperimental Treatment1 Intervention

investigational IOL Model DEN00V

Group II: Control Lens DeviceActive Control1 Intervention

control IOL Model ZCB00/DCB00

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for cataracts involves the surgical removal of the clouded lens and its replacement with an intraocular lens (IOL). IOLs, such as the TECNIS IOL, Model DEN00V, are designed to improve visual acuity by providing a clear, artificial lens that replaces the natural, clouded one. These lenses also reduce spherical aberration, which is a common optical issue where light rays entering the eye are not focused at the same point, leading to blurred vision. By addressing spherical aberration, these IOLs enhance the quality of vision, providing sharper and more accurate visual outcomes. This is crucial for cataract patients as it significantly improves their ability to perform daily activities and enhances their overall quality of life.

Posterior capsular opacification and intraocular lens decentration. Part I: Comparison of various posterior chamber lens designs implanted in the rabbit model.Phakic Posterior Chamber Intraocular Lens with a Central Hole in Treating Patients with Moderate to High Myopia: A Meta-Analysis.