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Ophthalmic Viscosurgical Device
Healon EndoCoat OVD for Cataract Surgery
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 up to 3-month follow-up
Awards & highlights
Study Summary
This trial compares two types of eye surgery with each other to see which is better.
Who is the study for?
This trial is for adults over 22 with cataracts planned for lens implant surgery, who can see at least 20/40 after surgery. They must understand and follow the study procedures and have signed consent forms. Excluded are those with recent eye trauma/surgery, certain medications affecting vision or IOP, uncontrolled diabetes, low endothelial cell count, other eye diseases that affect vision or require treatment during the study.Check my eligibility
What is being tested?
The study compares an experimental Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) to a control version in a masked setup where neither participants nor evaluators know which product each patient receives. It's randomized and involves both eyes of each participant.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include temporary visual disturbances, discomfort in the eye area, increased intraocular pressure or potential allergic reactions to components of the OVD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3-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
CUMULATIVE RATE OF INTRAOCULAR PRESSURE (IOP) SPIKES 30 MMHG OR GREATER
MEAN PERCENT ENDOTHELIAL CELL COUNT (ECC) CHANGE PREOPERATIVELY VS. POSTOPERATIVELY
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational Healon EndoCoatExperimental Treatment2 Interventions
Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.
Group II: Control Healon EndoCoatActive Control2 Interventions
Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Investigational Healon Endocoat
2022
N/A
~170
Control Healon EndoCoat
2022
N/A
~170
Find a Location
Who is running the clinical trial?
Johnson & Johnson Surgical Vision, Inc.Lead Sponsor
34 Previous Clinical Trials
7,893 Total Patients Enrolled
29 Trials studying Cataract
6,664 Patients Enrolled for Cataract
Johnson & Johnson Surgical Vision, Inc. Clinical TrialStudy DirectorJohnson & Johnson Surgical Vision, Inc.
7 Previous Clinical Trials
3,878 Total Patients Enrolled
6 Trials studying Cataract
3,843 Patients Enrolled for Cataract
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The patient has clear intraocular media, other than cataract.You have eye conditions that are expected to make your vision worse than 20/40 during the study, or could affect the results of the study.You have a medical condition that could make the study riskier or affect the study results. This could include conditions that weaken your immune system, certain eye diseases like glaucoma or inflammation, or other chronic health issues.You have a BCDVA of 20/40 or better.You have had surgery on your eyes to correct your vision, like LASIK or PRK.You have a diagnosed eye condition that is expected to cause significant vision loss during the study.You are pregnant, planning to get pregnant, breastfeeding, or have a condition that may cause changes in your vision due to hormonal fluctuations.Your pupils do not react properly to light or they are an unusual shape.You have certain eye conditions that increase the risk of lens displacement or tilting, such as pseudoexfoliation, previous eye injury, or defects in the back part of the lens.You have a known sensitivity or strong reaction to steroids.You have cataracts in both eyes and are scheduled to have them surgically removed and replaced with an artificial lens.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational Healon EndoCoat
- Group 2: Control Healon EndoCoat
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.
Cataract Patient Testimony for trial: Trial Name: NCT05575063 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available in this clinical research program?
"This research project, which was initially uploaded to clinicaltrials.gov on November 8th 2022 is presently seeking participants. The data associated with this study has been recently amended as of November 28th 2022."
Answered by AI
How many subjects have enrolled in this medical experiment?
"Affirmative. The information found on clinicaltrials.gov indicates that this experiment is still enrolling participants. It was initially made available to the public on November 8th 2022 and has been modified most recently on 28th of the same month. 150 test subjects are being sought from 6 different locations."
Answered by AI
At what number of medical institutions is the trial being conducted?
"There are presently 6 sites recruiting participants for this trial, which range from Bradenton to Houston and Bakersfield. It is advisable that enrolled patients pick a site closest to them in order to minimize the necessity of travel."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Texas
How old are they?
18 - 65
What site did they apply to?
Focal Point Vision
Parkhurst NuVision
Virginia Eye Consultants
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'm hoping for the best outcome for my cataract surgery. Unable to get a job due to my disability. Ophthalmologist referred me to other locations for to see if they would help me since I’m not employed or have insurance. However no one wants to help me.
PatientReceived 2+ prior treatments
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