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LASIK correction of myopic refractive errors

Phase 3

Myopia | Unknown | Ophthalmology |Abbott Laboratories|Last Updated: Feb 4, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment170

FDA Designations

No designations recorded

Clinical trial landscape

LASIK correction of myopic refractive errors · 1 trial · 1 indication

Phase 3 1
NCT01663363Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive ErrorsMyopia
COMPLETED170 Analytics
PHASE3COMPLETED
Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors
MyopiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
6 Months

Secondary Endpoints

Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better
6 Months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
wavefront-guided LASIKEXPERIMENTALLASIK correction of myopic refractive errors. Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.

Interventions

NameTypeDescription
LASIK correction of myopic refractive errorsDEVICESurgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * 18 years of age or greater * Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better * Uncorrected visual acuity (UCVA) of 20/40 or worse * Less than 0.75D difference between cycloplegic and manifest refraction sphere. * Demonstration of refractive stability * Antici...

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Competitive Landscape -Myopia 16 trials

Frequently asked questions about LASIK correction of myopic refractive errors

What is LASIK correction of myopic refractive errors used for?

LASIK correction of myopic refractive errors is a surgical procedure used to treat myopia, or nearsightedness. It aims to reshape the cornea to correct refractive errors and reduce dependence on glasses or contact lenses. The procedure is being studied in a Phase 3 clinical trial for patients with myopia.

Who makes LASIK correction of myopic refractive errors?

LASIK correction of myopic refractive errors is developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker ABT. Abbott Laboratories is conducting clinical research on this procedure for the treatment of myopia.

What phase is LASIK correction of myopic refractive errors in?

LASIK correction of myopic refractive errors is in Phase 3 clinical development. It is an investigational procedure and has not been approved by the FDA. The Phase 3 trial has been completed, with 170 participants enrolled.

What clinical trials is LASIK correction of myopic refractive errors in?

LASIK correction of myopic refractive errors has one completed Phase 3 clinical trial, identified as NCT01663363. The trial, titled 'Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors,' enrolled 170 participants with myopia and was an uncontrolled, non-randomized study.

Is LASIK correction of myopic refractive errors the same as wavefront-guided LASIK?

LASIK correction of myopic refractive errors is being studied as a wavefront-guided LASIK procedure. The clinical trial NCT01663363 specifically evaluates wavefront-guided LASIK corrections for myopic refractive errors, indicating that the procedure uses wavefront technology to guide the laser treatment.