The purpose of this study is to evaluate the safety and effectiveness of the ALLEGRETTO WAVE EYE-Q excimer laser system for the reduction of myopia with or without astigmatism in subjects undergoing photorefractive keratectomy (PRK) treatment.
This was a prospective, multi-center, single group study. Subjects underwent bilateral PRK in which the second eye was treated no sooner than 1 week and no later than 30 days after the first eye's PRK treatment. Subjects were followed for 2 years after surgery. The protocol underwent 4 amendments. The key differences between the protocol versions were clarifications of the planned analyses and adverse event reporting procedures. There were no changes in the inclusion and exclusion criteria or non-adverse event related study assessments between the protocol versions 1-5. Refractive stability of manifest refraction spherical equivalent (MRSE) and manifest refractive cylinder was defined as established when: * At least 95% of the treated eyes had a change ≤ 1.0 diopter between manifest refractions performed at any 2 manifest refractions at least 3 months apart * The mean rate of change, as determined by a paired analysis, was ≤ 0.5 diopter per year (0.04 D/month) over the same time period * The mean rate of change decreased monotonically over time, with a projected asymptote of zero or a rate of change attributable to normal aging * The 95% confidence interval for the mean rate of change included zero or a rate of change attributable to normal aging. Refractive stability was assessed for pairs of visits within an interval and was defined to occur at the latter time point of the first interval at which stability was achieved. In the final amendment to the protocol, 3 secondary objectives were made co-primary in response to Agency comments. All endpoints and analyses were modified to match.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
176
In this corneal surgical procedure, the outer corneal epithelial layer will be removed, after which the corneal stroma will be reshaped by excimer laser ablation to reduce or eliminate refractive errors.
The ALLEGRETTO WAVE EYE-Q excimer laser system is used for corneal stroma reshaping during PRK surgery
Percentage of Eyes Achieving Uncorrected Visual Acuity (UCVA) of 20/40 or Better at Refractive Stability in Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) of 20/20 or Better Preoperatively
Visual acuity, with and without correction, was assessed monocularly using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters under photopic conditions . The with-correction assessment was made with the manifest refraction at 4 meters.
Time frame: Month 6 (post second eye surgery)
Percentage of Eyes Achieving Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.0 D of Zero at Refractive Stability
Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.
Time frame: Month 6 (post second eye surgery)
Percentage of Eyes Achieving MRSE Within ± 0.5 D of Zero at Refractive Stability
Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.
Time frame: Month 6 (post second eye surgery)
Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 1.0 D of Zero at Refractive Stability
Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.
Time frame: Month 6 (post second eye surgery)
Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 0.5 D of Zero at Refractive Stability
Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.
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Time frame: Month 6 (post second eye surgery)
Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits
MRSE is calculated as sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.
Time frame: Up to Month 24 (post second eye surgery)
Cumulative Incidence of Ocular Serious Adverse Events by Eye
Participants were followed for the duration of the study, an expected average of 24 months.
Time frame: Up to Month 24 (post second eye surgery)
Percentage of Eyes With BSCVA Decrease of ≥ 2 Lines From Baseline at Refractive Stability
Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions . A decrease in 2 lines or more is considered clinically relevant (i.e. worse).
Time frame: Month 6 (post second eye surgery)
Percentage of Eyes With a BSCVA Worse Than 20/40 (for Eyes With BSCVA of 20/20 or Better Preoperatively) at Refractive Stability
Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions .
Time frame: Month 6 (post second eye surgery)
Percentage of Eyes With > 2.0 D of Induced Manifest Refractive Cylinder Magnitude, as Compared to Baseline, at Refractive Stability
Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. The cylinder value is from the manifest refraction assessment. The induced manifest refractive cylinder is the change in magnitude of cylinder compared to baseline.
Time frame: Month 6 (post second eye surgery)