Contoura With Phorcides Compared to Wavefront Optimized LASIK

Study Overview
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Brief Summary
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Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized.

Official Title
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Comparison of Visual Acuity and Quality of Life Following Contoura With Phorcides Compared to WaveLight Wavefront Optimized LASIK

Conditions
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Myopia, Astigmatism

Intervention / Treatment
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* Procedure: Contoura with Phorcides
* Device: WaveLight Wavefront Optimized


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at least age 21 years of age undergoing LASIK eye surgery Willing and able to comprehend informed consent and complete 1 month post-op visit Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion Candidates for Contoura with Phorcides (Myopic, astigmatism <3.0D) Both eyes targeted for plano Pre-operative total corneal Pachymetry 490um or above Stable refractive error <0.50D change in preceding year Good general and ocular health Pre-operative exam completed within three months of surgery SCL discontinued 3 days prior to pre-op exam and the procedure Pachymetry above 490 with residual greater than 270um Candidates who, as determined by the investigator, can safely undergo LASIK Exclusion Criteria: Patients under 21 years of age Concomitant ocular condition which would limit the BCVA at the discretion of the surgeon Patients with usual relative and absolute contraindications for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes) Pachymetry below 490 Autoimmune or immunodeficiency diseases Pregnant or nursing women Patients with signs of inability to understand consent for study and procedure planned Patients with history of previous ocular surgery Patients with strabismus or amblyopia Patients that have a BCDVA of 20/25 or worse in either eye

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 38 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study: Phorcides<br>Contoura with Phorcides used for surgical planning of LASIK procedure | Procedure: Contoura with Phorcides<br>* Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine<br>|
| Active Comparator: Control: Wavefront Optimized<br>WaveLight Wavefront Optimized used for surgical planning of LASIK procedure | Device: WaveLight Wavefront Optimized<br>* Participants that undergo LASIK surgery using WaveLight Wavefront Optimized<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Op UDVA | Percent of participants with monocular UDVA of 20/16 or better | 3 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-OP BCVA | Percent of participants with monocular and binocular BCVA of 20/16 or better | 3 months post-op | 
| Residual Refractive Error | Residual astigmatism and residual SE | 3 months post-op | 
| Low Contrast Visual Acuity | 25% low contrast visual acuity post-op | 3 months post-op | 
| Pre-op and post-op visual acuity | Percent of participants with post-op UDVA equal to or better than their pre-op CDVA | 3 months post-op | 
| Corrected Distance Visual Acuity | Compare percent of participants with post-operative and pre-operative CDVA | 3 months post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual acuity, Refractive outcome, LASIK, Contrast sensitivity, Wavefront Optimized, Topography-guided