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Device
ELITA System for Refractive Errors
N/A
Recruiting
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
Anticipated residual corneal stromal thickness of at least 250 microns based on preoperative corneal pachymetry minus calculated maximum lenticule thickness to be extracted
Any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability according to the following: Rigid, toric, or extended wear contact lenses (toric or spherical) must be removed for at least 2 weeks and soft contact lenses (spherical) for at least 3 days prior to the first refraction used to establish stability. Two consecutive manifest refractions and keratometry readings must be conducted at least 7 days apart. Refractive stability is defined as a change of not more than 0.50 D in manifest refractive sphere and cylinder as well as keratometry meridian (either axis) between measurements. If the subject meets the refractive stability criteria, contact lens wear is not permitted for 2 weeks (rigid/toric/extended wear) or 3 days (soft) prior to surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months or at the point of refractive stability
Awards & highlights
Study Summary
This trial will test a new medical system for safety and effectiveness.
Who is the study for?
Adults over 22 with myopia up to -10.00 D and astigmatism up to -5.00 D, stable vision for at least a year, and good overall eye health can join this trial. They must not have used certain contact lenses recently and should be willing to follow the study's check-up schedule. Pregnant women or those on specific medications affecting healing are excluded.Check my eligibility
What is being tested?
The ELITA System is being tested in adults with certain types of vision errors (myopia and astigmatism). The study will look at how safe and effective it is through two phases without comparing it to other treatments.See study design
What are the potential side effects?
While the side effects aren't listed here, similar eye procedures may cause discomfort, dry eyes, visual disturbances like glare or halos, infection risk, or potentially incomplete correction requiring further treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eye's cornea will remain thick enough after surgery.
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I haven't worn contact lenses for the required time before my eye measurements.
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I am 22 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months or at the point of refractive stability
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months or at the point of refractive stability
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maintenance of BSCVA
Monocular UCVA
Secondary outcome measures
Corneal Haze Beyond 6 Months with Loss of > 2 lines of BSCVA
Induced Manifest Refractive Astigmatism
MRSE Predictability
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ELITA SystemExperimental Treatment1 Intervention
Each subject will receive a SILK lenticule removal procedure on one eye and a commercially available laser vision correction procedure on their fellow eye (Feasibility Phase). Subjects will receive a lenticule removal procedure on both eyes to reduce or eliminate myopic refractive errors (Pivotal Phase). The second eye treatment will be considered only after the first eye 1-week follow up visit has been completed and safety criteria are met.
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Who is running the clinical trial?
Johnson & Johnson Surgical Vision, Inc.Lead Sponsor
35 Previous Clinical Trials
7,858 Total Patients Enrolled
4 Trials studying Refractive Errors
3,590 Patients Enrolled for Refractive Errors
Johnson & Johnson Surgical Vision, Inc. Clinical TrialsStudy DirectorJohnson & Johnson Surgical Vision, Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had eye surgery or have ongoing eye conditions.My eye's cornea will remain thick enough after surgery.I am not using medications that could affect healing, like Accutane or Cordarone.My eyes are not eligible for specific laser treatments.You have certain eye conditions or characteristics that may make it difficult to maintain proper suction during the treatment. These include deep-set eyes, strong blinking, anxiety, pterygium, difficulty following instructions or focusing, head tremors, or any other signs that may increase the risk of a problem with the treatment.I have an eye condition affecting my cornea's shape or thickness.I do not have conditions like lupus, diabetes, or autoimmune diseases that affect healing.I haven't worn contact lenses for the required time before my eye measurements.I am willing and able to follow the study's check-up schedule.I am 22 years old or older.I have glaucoma or high eye pressure above 21 mmHg.You have had a bad reaction or did not respond well to any of the medications used after a previous surgery.I want to correct my vision for seeing with one eye differently than the other.Your eyesight is worse than 20/40 and cannot be improved with glasses or contacts.
Research Study Groups:
This trial has the following groups:- Group 1: ELITA System
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.
Is there an open call for participants in this clinical trial?
"The information hosted on clinicaltrials.gov suggests that this trial is no longer enrolling patients, having last been updated on January 25th 2023 after first appearing online February 6th of the same year. However, there are 26 other studies actively recruiting at present."
Answered by AI
What is the objective of this clinical experiment?
"The primary endpoint of the Johnson & Johnson Surgical Vision, Inc. trial is Maintenance of BSCVA over a 6-month period or until refractive stability has been reached. In addition to this main outcome measure, other secondary parameters such as preservation of 20/40 vision rates, Induced Manifest Refractive Astigmatism above 2 diopters and beyond six months with Corneal Haze leading to visual acuity loss greater than two lines are being monitored."
Answered by AI
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