The purpose of this study is to collect efficacy and safety data on the WaveLight EX500 excimer laser system for the correction of hyperopia with and without astigmatism by laser in situ keratomileusis (LASIK) treatment.
Qualified subjects will receive LASIK treatment in both eyes and be followed for 1 year. Subjects will be asked to attend a total of 9 visits (Screening, Surgery, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, and Month 12). Total expected duration of subject participation is approximately 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
FDA approved stationary scanning-spot excimer laser system used during refractive surgery for the treatment of myopia, myopic astigmatism, hyperopia, hyperopic astigmatism, and mixed astigmatism. For this clinical study, the Wavefront Optimized (WFO) Ablation profile of the WaveLight EX500 excimer laser system will be used for bilateral LASIK treatment of hyperopia with and without astigmatism.
Procedure that reshapes the front part of the eye (cornea) so that light traveling through it is properly focused on the back part of the eye (retina). The procedure will be performed using the WaveLight EX500 excimer laser system.
Durrie Vision
Overland Park, Kansas, United States
Moyes Eye Center
Kansas City, Missouri, United States
Physicians Protocol
Greensboro, North Carolina, United States
Vance Thompson Vision ND
West Fargo, North Dakota, United States
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability
A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. For this endpoint, change in MRSE by less than or equal to 0.50 D was reported. Both eyes contributed data to this analysis.
Time frame: Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)
Percentage of Eyes With MRSE Within ±1.00 D at Refractive Stability
A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. For this endpoint, change in MRSE by less than or equal to 1.00 D was reported. Both eyes contributed data to this analysis.
Time frame: Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)
Percentage of Eyes Experiencing Ocular Adverse Events (AEs)
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). Ocular adverse events were collected for this outcome measure. No hypothesis testing was prespecified for this endpoint.
Time frame: Up to Month 12 postoperative
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Mann Eye Institute
Houston, Texas, United States