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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
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
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
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
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.
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.
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Who is running the clinical trial?
Johnson & Johnson Surgical Vision, Inc.Lead Sponsor
36 Previous Clinical Trials
8,112 Total Patients Enrolled
31 Trials studying Cataract
6,883 Patients Enrolled for Cataract
Johnson & Johnson Surgical Vision, Inc. Clinical TrialStudy DirectorJohnson & Johnson Surgical Vision, Inc.
8 Previous Clinical Trials
4,041 Total Patients Enrolled
7 Trials studying Cataract
4,006 Patients Enrolled for Cataract
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pupils do not react normally or are abnormally shaped.You have a preoperative BCDVA of 20/40 or worse with or without a glare source.My diabetes is not well-managed.You have a condition called corneal astigmatism.I am not taking any medications that could affect my vision.I have had recent eye injury that hasn't healed.I am at least 22 years old.I have signed all necessary consent and privacy documents for treatment.I have eye conditions that could worsen my vision to below 20/30.I have eye conditions that could cause lens displacement.I want to correct my vision for seeing clearly at one distance.I have had eye surgery to correct my vision.I have an eye condition that could affect my vision.I do not have any eye conditions that might need surgery during the study.I have had eye surgery, including for preventive reasons.I am scheduled for lens implants in both eyes due to cataracts.My eyes are clear of any issues except for cataracts.My vision could improve to 20/30 or better after surgery.I am willing and able to follow the study's procedures.I have an eye condition that might need surgery or laser treatment during the study.I have trouble focusing my eyes for long periods.My vision could be 20/30 or better after surgery.I do not have any health conditions that could worsen my surgery risk or affect the study's results.My eyes cannot maintain stable vision with contact lenses.I have an eye condition that may worsen my vision beyond 20/30.I am not using, and do not plan to use, tamsulosin or silodosin during the study.I am able and willing to follow the study's procedures.I am at least 22 years old.I am planning to have lens implants for cataracts in both eyes.
Research Study Groups:
This trial has the following groups:- Group 1: Control Lens Device
- Group 2: investigational Lens Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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