Clinical trial NCT01941498: WaveLight® Refractive Myopic Study
Official title: A Prospective, Global, Multi-Center Study for the Evaluation of Outcomes on Subjects Undergoing Myopic Treatments Using the WaveLight® Refractive Suite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: nearsighted
farsighted
astigmatism
LASIK
refractive surgery
WaveLight
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-09-13
Enrollment: 104
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 outcomes of subjects undergoing myopic surgery using the WaveLight® Refractive Suite (Excimer EX500 and Femtosecond FS200 lasers).


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.
* History of dry eye that is unresponsive to treatment.
* 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: Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA
timeFrame: Month 1
Secondary outcomes:
measure: Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT
timeFrame: Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative
measure: Mean Manifest Refraction (Sphere)
timeFrame: Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
measure: Mean Manifest Refraction (Cylinder)
timeFrame: Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
measure: Mean Laser Treatment Time
timeFrame: Day 0 (surgery)
measure: Mean Total Laser Treatment Time
timeFrame: Day 0 (surgery)
measure: Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"
timeFrame: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
measure: Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..."
timeFrame: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
measure: Percent Response by Category: "I Worry About my Vision"
timeFrame: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
measure: Percent Response by Category: "My Vision Is a Concern in My Daily Life"
timeFrame: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
measure: Percent Response by Category: "Driving at Night"
timeFrame: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
measure: Mean Contrast Sensitivity (CS)
timeFrame: Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
measure: Wavefront Aberrometry
timeFrame: Baseline (Day 0), Month 6 Postoperative
measure: Corneal Curvature as Measured by Keratometry
timeFrame: Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Manager, GMA, Surgical
role: STUDY_DIRECTOR
References: