Refractive Error Clinical Trial
Official title:
A Prospective, Global, Multi-Center Study to Evaluate Longitudinal Flap Accuracy on Subjects Undergoing Myopic Refractive Surgery Using the WaveLight® Refractive Suite
The purpose of this study is to evaluate the accuracy of the WaveLight FS200 femtosecond laser, as assessed by 1 day and 1 month post-operative OCT anterior segment corneal measurements compared to pre-operative flap thickness target.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2015 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Willing and able to understand and sign an informed consent form. - Have refractive error (in both eyes) that requires refractive surgery. - Willing to undergo LASIK surgery using the Wavelight® Refractive Suite. - Myopia between 0.00 to -12.0 Diopters pre-operatively. - Astigmatism between 0.00 to +6.00 Diopters pre-operatively. - Willing and able to attend post-operative examinations per protocol schedule. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Participation in a clinical study within the last 30 days. - History of previous corneal surgery in either eye. - Multifocal ablations in either eye. - PRK or PTK surgery in either eye. - Suffering from acute or recurring eye diseases in either eye, such as corneal ulcers, cataract, etc. - Any ocular disease and/or condition that, in the Investigator's clinical judgment, may put subject at significant risk, compromise study results, or interfere significantly with subject's participation in the study. - Unable to discontinue contact lens wear as specified in protocol. - History of Herpes simplex or Herpes zoster keratitis. - Active ocular rosacea. - Lyme disease. - Severe ocular allergies. - Other medical conditions and use of medications as specified in protocol. - Pregnant or planning to become pregnant during the study. - Other protocol-specified exclusion criteria may apply. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Alcon Research |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively | The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness at Day 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). | Day 1 | No |
Secondary | Opaque Bubble Layer (OBL) Development | OBL (ie, a complication of corneal flap creation) assessed by digital photo analysis. | Day 0 (operative day) | No |
Secondary | The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively | The expected flap thickness as determined pre-operatively subtracted from the achieved flap thickness at Month 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). | Month 1 | No |
Secondary | Uncorrected Visual Acuity (UCVA) | Visual acuity (VA) without spectacles or other visual corrective devices, assessed a distance of 4 meters and measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity. | Up to Month 12 | No |
Secondary | Best Corrected Visual Acuity (BCVA) at Distance | VA with the participant's best spectacles or other visual corrective devices assessed at a distance of 4 meters and measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity. | Up to Month 12 | No |
Secondary | Manifest Refraction | Manifest refraction as performed using visual acuity charts at a distance of 4 meters to document the sphere, cylinder and axis readings, measured in diopters. | Up to Month 12 | No |
Secondary | Contrast Acuity | Contrast acuity (ie, a measurement of the ability to see between different shades of gray from the background) assessed in accordance with the manufacturer's guidelines, measured in logCS. A higher logCS value indicates better contrast acuity. | Up to Month 12 | No |
Secondary | Corneal Flap Diameter | Diameter of the corneal flap as assessed by OCT and measured in microns. | Up to Month 12 | No |
Secondary | Wavefront Aberrometry | Wavefront error of the eye as measured with a commercially available system and recorded in microns. | Up to Month 12 | No |
Secondary | Quality of Life as Reported on RSVP Questionnaire | The Refractive Status and Vision Profile (RSVP) is a self-reported questionnaire used to measure vision-related health status in persons with refractive error. | Up to Month 12 | No |
Secondary | Corneal Curvature as Measured by Keratometry | Corneal curvature as assessed by a commercially available system and measured in diopters. | Up to Month 12 | No |
Secondary | Flap Creation Time | Treatment time with Femtosecond FS200 laser, measured in seconds. | Day 0 (operative day) | No |
Secondary | Corneal Topography | Corneal topography as assessed by a commercially available system. | Up to Month 12 | No |
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