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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
Must not have
Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography
History of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1 mm from limbus), retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, prior strabismus surgery, strabismus, or at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma or suspected glaucoma. NOTE: Subjects with glaucoma, regardless of medication regimen or control, or an IOP greater than 21 mmHg at screening, are specifically excluded from eligibility
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial involves eye surgery to help people with vision problems achieve stable eyesight. It targets individuals who need surgical correction for their vision. The surgery works by fixing how the eyes focus light, leading to clearer and more stable vision.

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.
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.
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 below
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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.
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One of my eyes needs treatment for nearsightedness.
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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a diagnosed eye condition affecting the shape of my cornea.
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I have no history of major eye problems or surgeries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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].

Find a Location

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

Wavefront-guided LASIK (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04075591 — N/A
Wavefront-guided LASIK (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04075591 — N/A
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