What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Refractive surgeries like LASIK and PRK, which alter the shape of the cornea to correct refractive errors, are generally safe but can have side effects. Common side effects include dry eye syndrome, decreased tear production, glare, halos, and starbursts around lights, particularly at night. Some patients may experience under-correction or over-correction of their vision, necessitating additional procedures. There is also a risk of infection and, in rare cases, corneal ectasia, where the cornea becomes weakened and distorted.

What prior FDA approvals exist?

The FDA has approved several surgical procedures for the treatment of refractive errors, primarily focusing on techniques that alter the shape of the cornea. These include Laser-Assisted In Situ Keratomileusis (LASIK) and Photorefractive Keratectomy (PRK). Both procedures use an excimer laser to reshape the cornea, thereby correcting myopia, hyperopia, and astigmatism. Additionally, the FDA has approved the use of femtosecond lasers for creating corneal flaps in LASIK, enhancing precision and safety. While these procedures do not typically involve long-term drug treatments, topical corticosteroids are sometimes used postoperatively to reduce inflammation, although their long-term use is not recommended due to potential side effects.

What other types of research exist?

Promising, novel alternatives to refractive surgery for treating refractive errors in 2024 include: 1) Orthokeratology (Ortho-K) lenses, which are specially designed contact lenses worn overnight to temporarily reshape the cornea; 2) Implantable Collamer Lenses (ICLs), which are surgically inserted into the eye to correct vision without altering the cornea; 3) Corneal inlays, small devices implanted into the cornea to improve near vision; and 4) Advanced wavefront-guided LASIK alternatives, which use detailed measurements of the eye to customize treatments for better outcomes.

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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:

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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.

0 / 5Eligibility criteria met

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].