A Prospective, Global, Multi-Center Study for the Evaluation of Outcomes on Subjects Undergoing Myopic Treatments Using the WaveLight® Refractive Suite

Alcon Research0 sites104 target enrollmentSeptember 2013

ConditionsRefractive Error

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Refractive Error
Sponsor: Alcon Research
Enrollment: 104
Primary Endpoint: Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

August 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA

Time Frame: Month 1

Visual acuity (VA) with corrective devices (BCVA) was assessed binocularly (both eyes together) pre-treatment and subtracted from VA without spectacles or other visual corrective devices (UCVA) assessed binocularly at 1 month post-treatment. VA was measured at a distance of 4 meters and reported in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A negative value indicates an improvement in VA from pre-treatment to Month 1.

Secondary Outcomes

Wavefront Aberrometry(Baseline (Day 0), Month 6 Postoperative)
Corneal Curvature as Measured by Keratometry(Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative)
Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT(Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative)
Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"(Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative)
Mean Contrast Sensitivity (CS)(Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative)
Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..."(Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative)
Mean Total Laser Treatment Time(Day 0 (surgery))
Percent Response by Category: "I Worry About my Vision"(Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative)
Mean Manifest Refraction (Sphere)(Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative)
Mean Manifest Refraction (Cylinder)(Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative)
Mean Laser Treatment Time(Day 0 (surgery))
Percent Response by Category: "My Vision Is a Concern in My Daily Life"(Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative)
Percent Response by Category: "Driving at Night"(Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative)