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Procedure
Wavefront-guided LASIK for Presbyopia
N/A
Recruiting
Research Sponsored by AMO Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The refractive error of both subject's eyes, based on the iDesign refraction selected for treatment ("4.0 mm Rx calc" at 12.5 mm), must be myopic with or without astigmatism up to -6.00 D spherical equivalent (SE), with cylinder up to -3.00 D and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopic retention
At least one eye must require a myopic treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will enroll 383 people at 8-14 sites to study an experimental surgery. The follow-up visit schedule will be the same for each eye that has the surgery.
Who is the study for?
This trial is for people over 40 with myopia and presbyopia who need at least +1.25 D to +2.00 D reading add power, have stable vision, and can follow the study's schedule. Pregnant women or those on certain medications affecting healing are excluded.Check my eligibility
What is being tested?
The trial tests a LASIK surgery using iDesign Refractive Studio with STAR S4 IR® Excimer laser System for monovision correction in myopic subjects with presbyopia over a period of 12 months across multiple centers.See study design
What are the potential side effects?
Potential side effects may include discomfort, dry eyes, light sensitivity, visual disturbances like glare or halos around lights, and potential undercorrection or overcorrection of vision.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eyesight is nearsighted up to -6.00 D with astigmatism up to -3.00 D, and my non-dominant eye is as nearsighted as the treatment targets.
Select...
One of my eyes needs treatment for nearsightedness.
Select...
I am 40 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The change in driving scale score from preoperative to postoperative as measured by the driving scale within the PROWL-M (Patient-Reported Outcomes with LASIK for monovision) questionnaire
The proportion of subjects who required secondary surgery to reverse monovision
Trial Design
1Treatment groups
Experimental Treatment
Group I: Wavefront-guided Lasik Monovision TreatmentExperimental Treatment1 Intervention
Wavefront-guided LASIK monovision treatment of myopic subjects with presbyopia using the STAR S4 IR® Excimer laser System with the iDesign Refractive Studio.
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
Refractive surgery, such as LASIK (Laser-Assisted In Situ Keratomileusis) and PRK (Photorefractive Keratectomy), corrects refractive errors by reshaping the cornea to improve the eye's ability to focus light directly onto the retina. In LASIK, a flap is created on the cornea's surface, and an excimer laser is used to remove a precise amount of corneal tissue, thereby altering its curvature.
PRK, on the other hand, involves removing the outer layer of the cornea before reshaping the underlying tissue with a laser. These procedures are crucial for patients with refractive errors like myopia, hyperopia, and astigmatism because they can significantly reduce or eliminate the need for glasses or contact lenses, thereby improving visual acuity and quality of life.
To Correct or Not Correct? Actual Evidence, Controversy and the Questions That Remain Open.Theoretical Analysis of Wave-Front Aberrations Induced from Conventional Laser Refractive Surgery in a Biomechanical Finite Element Model.[Possible functional treatment of myopia in children].
To Correct or Not Correct? Actual Evidence, Controversy and the Questions That Remain Open.Theoretical Analysis of Wave-Front Aberrations Induced from Conventional Laser Refractive Surgery in a Biomechanical Finite Element Model.[Possible functional treatment of myopia in children].
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Who is running the clinical trial?
AMO Development, LLCLead Sponsor
Johnson & Johnson Surgical Vision Inc. Clinical TrialStudy DirectorJohnson & Johnson Surgical Vision, Inc.
AMO Development, LLC Clinical TrialStudy DirectorAMO Development, LLC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot tolerate monovision correction as per a contact lens trial.Your cornea has to be thick enough to safely perform the surgery, which means it needs to have a certain minimum thickness after taking into account the planned treatment depth.You have had a bad reaction or your body doesn't respond well to any of the medications used after surgery.I haven't taken any medications in the past 6 months that could affect healing.I have a diagnosed eye condition affecting the shape of my cornea.My eyesight is nearsighted up to -6.00 D with astigmatism up to -3.00 D, and my non-dominant eye is as nearsighted as the treatment targets.One of my eyes needs treatment for nearsightedness.I have no history of major eye problems or surgeries.I haven't worn contact lenses for the required time to test my eye's focus stability.I do not have conditions like lupus, diabetes, or autoimmune diseases that affect healing.I am 40 years old or older.I am willing and able to follow the study's check-up schedule.
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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