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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
Study Summary
This trial compares the safety & effectiveness of two types of lenses in eye surgery: one with & one without a special design.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MONOCULAR PHOTOPIC BCDVA AT 4 M
MONOCULAR PHOTOPIC DCIVA AT 66 CM
Secondary Surgical Interventions (SSIs)
Secondary outcome measures
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
Find a Location
Who is running the clinical trial?
Johnson & Johnson Surgical Vision, Inc.Lead Sponsor
34 Previous Clinical Trials
7,808 Total Patients Enrolled
29 Trials studying Cataract
6,579 Patients Enrolled for Cataract
Johnson & Johnson Surgical Vision, Inc. Clinical TrialStudy DirectorJohnson & Johnson Surgical Vision, Inc.
7 Previous Clinical Trials
3,793 Total Patients Enrolled
6 Trials studying Cataract
3,758 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How extensive is the patient sample size for this trial?
"Johnson & Johnson Surgical Vision, Inc. is sponsoring a study requiring 250 eligible patients from multiple medical sites such as Jones Eye Center in Sioux City, Iowa and Carolina EyeCare Physicians, LLC of Mount Pleasant, South carolina."
Answered by AI
Is registration open for participants in this experiment?
"Affirmative. Per clinicaltrials.gov, this medical investigation is currently open to volunteers and was first listed on October 24th 2022 before being reviewed again November 28th of the same year. The study aims to recruit 250 patients from nine separate locations."
Answered by AI
Are there numerous facilities in the US conducting this research?
"At present, this medical trial is running in 9 discrete locations around the United States. These sites include Sioux City, Mount Pleasant and Cincinnati among other nearby areas. It is recommended to pick a nearby site when enrolling to keep travel requirements low."
Answered by AI
Who else is applying?
What state do they live in?
New York
North Carolina
Texas
How old are they?
18 - 65
What site did they apply to?
Focal Point Vision
Parkhurst NuVision
OCLI Vision
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I would like to have the best possible post-surgical outcome possible. I have cataracts in both eyes and as a former licensed optician, I want to have some ability to have good depth of focus and the best overall vision possible. I have a mild rx,so hopefully that makes me a good candidate.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
I know you will do one eye at a time, how long before the other is done?
PatientReceived 1 prior treatment
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