Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors

Study Overview
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Brief Summary
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Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe and effective for the treatment of Hyperopia.

Official Title
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A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided Lasik Correction of Hyperopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4 IR™ Excimer Laser System

Conditions
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Hyperopia

Intervention / Treatment
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* Device: LASIK correction of hyperopic refractive errors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age at the time of pre-operative exam Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better Demonstration of refractive stability Anticipated post-operative stromal bed thickness of at least 250 microns Willing and capable of returning for follow-up examinations for the duration of the study Exclusion Criteria: Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study Concurrent use of topical or systemic medications that may impair healing History of any medical conditions that could affect wound healing History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s) Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course

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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Accepts Healthy Volunteers

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: wavefront-guided LASIK<br> | Device: LASIK correction of hyperopic refractive errors<br>* Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA) | Hypothesis: <5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better | Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters | 12 Months | 

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