Clinical Investigation of the WaveLight® EX500 Excimer Laser

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Year 1). Total expected duration of subject participation is approximately 1 year.

Official Title
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Clinical Investigation of the WaveLight® EX500 Excimer Laser for Hyperopic LASIK

Conditions
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Hyperopia, Hyperopic Astigmatism

Intervention / Treatment
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* Device: WaveLight EX500 excimer laser system
* Procedure: LASIK


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Intended to treat bilaterally; Hyperopia with or without astigmatism as specified in the protocol; Stable vision as specified in the protocol; Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Glaucoma; Cataracts; Previous eye surgery; Intent to have monovision treatment; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WaveLight EX500 excimer laser system<br>Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system | Device: WaveLight EX500 excimer laser system<br>* 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.<br>Procedure: LASIK<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of eyes with manifest refraction spherical equivalent (MRSE) within ±0.50 diopter (D) at refractive stability | A manifest refraction (manual refraction) will be performed using a phoropter. The spherical equivalent will be calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability is 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. | Preoperative, up to Month 12 | 
| Percentage of eyes with MRSE within ±1.00 D at refractive stability | A manifest refraction (manual refraction) will be performed using a phoropter. The spherical equivalent will be calculated by adding the sum of the sphere power with half of the cylinder power. Refractive stability is 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. | Preoperative, up to Month 12 | 
| Percentage of eyes experiencing ocular adverse events (AEs) | An AE is 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 will be collected for this outcome measure. | Up to Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LASIK, Refractive errors