Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software

Study Overview
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Brief Summary
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The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction.

Detailed Description
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The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction. Data will be compared to published results for wavefront optimized LASIK and LASIK performed with Contoura using other refractive algorithms. The hypothesis is that use of the Phorcides planning software will result in a higher percentage of eyes with residual refractive cylinder ≤ 0.25D than will be achieved with wavefront-optimized (WFO) LASIK. It is also expected that unaided postoperative visual acuity and visual symptoms will be improved.

Official Title
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Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: Phorcides Analytical Engine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidate for Contoura excimer laser vision correction Gender: males and females. Age: 20 or older Willing and able to provide written informed consent for participation in the study. Willing and able to comply with scheduled visits and other study procedures. Good ocular health, with no pathology that compromises visual acuity (other than refractive error) Corrected preoperative visual acuity of 20/20 (0.0 logMAR) or better in the eye being treated Meet Contoura eligibility requirements (approved range): up to -8.00 D sphere, up to -3.00 D cylinder, and a spherical equivalent no greater than -9.00 D Desire good vision at distance in both eyes Exclusion Criteria: Corneal pathology (e.g. opacities, epithelial basement membrane dystrophy, Fuchs' dystrophy, etc.) Previous corneal surgery (e.g., radial keratotomy, corneal refractive surgery or corneal transplant, DSAEK, DMEK, lamellar keratoplasty) Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) Desire for good uncorrected near vision in one or both eyes Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial Unsuitability for the trial, in the opinion of the investigator, for any reason Pregnancy or desire to become pregnant during the trial Intraoperative complications.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phorcides<br>Both eyes of subjects eligible for Contoura(R) topography-guided ablation with the Wavelight excimer laser, with surgery planned using Phorcides software. | Device: Phorcides Analytical Engine<br>* Surgery planning using the Phorcides analytical engine.<br>* Other names: Phorcides;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual Refractive Cylinder | Residual refractive cylinder in diopters | 3 months postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Distance Visual Acuity | Uncorrected visual acuity at distance (4-6m) | 3 months postop | 
| Residual Refractive Sphere | Residual refractive spherical equivalent in diopters | 3 months postop | 
| Satisfaction and Vision | A questionnaire related to visual quality and satisfaction after surgery | 3 months postop |