Clinical trial NCT01941485: WaveLight® Refractive Flap Accuracy Study
Official title: A Prospective, Global, Multi-Center Study to Evaluate Longitudinal Flap Accuracy on Subjects Undergoing Myopic Refractive Surgery Using the WaveLight® Refractive Suite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: nearsighted
astigmatism
LASIK
refractive surgery
WaveLight
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 optical coherence tomography (OCT) anterior segment corneal measurements compared to pre-operative flap thickness target.


Eligibility criteria: 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.

Primary outcomes:
measure: The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively
timeFrame: Day 1 Postoperative
Secondary outcomes:
measure: Incidence of Development of Opaque Bubble Layer (OBL)
timeFrame: Operation/Surgery (Day 1)
measure: Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap
timeFrame: Operation/Surgery (Day 1)
measure: The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively
timeFrame: Month 1 Postoperative
measure: Uncorrected Visual Acuity (UCVA)
timeFrame: Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Manifest Refraction (Sphere)
timeFrame: Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Manifest Refraction (Cylinder)
timeFrame: Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Mean Contrast Sensitivity (CS)
timeFrame: Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT)
timeFrame: Operation/Surgery (Day 1), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Wavefront Aberrometry
timeFrame: Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"
timeFrame: Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Percent Response to "Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks"
timeFrame: Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Percent Response by Category: "I Worry About my Vision"
timeFrame: Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Percent Response by Category: "My Vision is a Concern in my Daily Life"
timeFrame: Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Percent Response by Category: "Driving at Night"
timeFrame: Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Corneal Curvature as Measured by Keratometry
timeFrame: Baseline/Screening (Day 0), 1 Month Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Flap Creation Time as Documented in the Log Files
timeFrame: Operation/Surgery (Day 1)
measure: Corneal Topography: Q-value
timeFrame: Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Corneal Topography: Anterior Chamber (AC) Volume
timeFrame: Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Corneal Topography: Anterior Chamber (AC) Depth
timeFrame: Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
measure: Corneal Topography: Angles
timeFrame: Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sr. Clinical Manager, GCRA, Global Med Affairs, Operations
role: STUDY_DIRECTOR
References: