A Prospective Comparison of Alcon LADARVision Wavefront-guided LASIK Enhancement and Conventional LASIK Enhancement for the Correction of Residual Refractive Errors Following LASIK Procedures

Study Overview
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Brief Summary
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The purpose of this study is to conduct a prospective clinical trial to compare conventional and WFG LASIK for enhancements on post-LASIK patients. Differences in safety, efficacy, visual quality, and refractive stability will also be compared during this study.

Official Title
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A Prospective Comparison of Alcon LADARVision Wavefront-guided LASIK Enhancement and Conventional LASIK Enhancement for the Correction of Residual Refractive Errors Following LASIK Procedures

Conditions
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Refractive Errors

Intervention / Treatment
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* Procedure: WAVEFRONT- GUIDED LASIK ENHANCEMENT
* Procedure: CONVENTIONAL LASIK ENHANCEMENT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, of any race, and at least 21 years old at the time of the preoperative exam, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability. At least 6 months from original LASIK surgery. Stable refraction with more than 0.75D of spherical equivalent from the desired correction and have less than 1.50D of cylinder in the manifest refraction. Both eyes must be within 1.00D spherical equivalent of each other on the manifest refraction test. The eye to be treated with wavefront-guided enhancement must have at least a 9.5mm flap. Manifest refraction and LADARWave™ refractions must be within 1.00D. At least 3 lines potential improvement in UCVA. BSCVA of 20/20 or better. Good corneal flap and interface. Adequate corneal thickness for surgery (residual stromal bed > 280 microns). Able and willing to give informed consent. Located in the greater Washington DC area for a 12-month period. Access to transportation to meet follow-up requirements. Exclusion Criteria: Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Pregnancy will be ruled out with a urine pregnancy test. Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin, as determined by history. Medical condition(s), which, in the judgement of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex (As determined by history). Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or clinically significant lens opacity. Evidence of glaucoma or an intraocular pressure greater than 22mm Hg at baseline. Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye. Flap irregularity(striae, interface debris, scarring, or epithelium). Calculated residual stroma bed less than 280. Stable refraction with less than 0.75D of spherical equivalent from the desired correction and more than 1.5D of cylinder in the manifest refraction.

Ages Eligible for Study
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Minimum Age: 21 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Conventional LASIK Enhancement | Procedure: CONVENTIONAL LASIK ENHANCEMENT<br>* Laser treatment to correct residual refractive error left over from initial LASIK correction using LADARvision 4000 excimer laser system.<br>|
| Experimental: 1<br>Wavefront guided LASIK Enhancement | Procedure: WAVEFRONT- GUIDED LASIK ENHANCEMENT<br>* Laser treatment to correct residual refractive error left over from initial LASIK correction using wavefront guided LADARvision 4000 excimer laser system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.Safety 2. Efficacy 3. Refractive stability |  | one year after enhancement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Residual refractive error left over from initial LASIK correction., Higher Order aberrations measured using a wavefront analyzer.