WaveLight® Refractive Myopic Study

Not Applicable

Completed

• Conditions: Refractive Error
• Interventions: Device: Wavelight® Refractive Suite; Procedure: LASIK surgery

• Registration Number: NCT01941498
• Lead Sponsor: Alcon Research

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).

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-13
• Primary Completion: 2014-01
• Study Completion: 2014-08
• Results First Submitted: 2015-02-01
• Results First Submitted QC: 2015-02-01
• Results First Posted: 2015-03-11
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WaveLight Refractive Suite	Wavelight® Refractive Suite	LASIK surgery (laser in situ keratomileusis) per standard of care
WaveLight Refractive Suite	LASIK surgery	LASIK surgery (laser in situ keratomileusis) per standard of care

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA	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 Outcome Measures

Name	Time	Method
Wavefront Aberrometry	Baseline (Day 0), Month 6 Postoperative	Wavefront aberrations (optical imperfections of the eye that prevent light from focusing perfectly on the retina, resulting in defects in the visual image) were measured using a commercially available system. Higher order aberrations (i.e., spherical aberrations, coma, and trifoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology.
Corneal Curvature as Measured by Keratometry	Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative	Corneal curvature was assessed by a commercially available system and measured in diopters.
Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT	Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative	The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness as assessed by optical coherence tomography (OCT) (ie, an imaging method using light to capture three-dimensional images). A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number.
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	As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error, on a scale from 0 (completely blind) to 10 (perfect vision).
Mean Contrast Sensitivity (CS)	Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative	Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd), where 3.0 cpd = A, 6.0 cpd = B, 12.0 cpd = C, and 18.0 cpd = D. Raw scores were log transformed. A higher numeric value represents better contrast sensitivity.
Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..."	Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative	As recorded by the subject on the RSVP questionnaire, where n/a means no use of glasses or contact lenses.
Mean Total Laser Treatment Time	Day 0 (surgery)	Total treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds. Total duration for both eyes was calculated as sum of duration for the right eye and left eye.
Percent Response by Category: "I Worry About my Vision"	Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative	As recorded by the subject on the RSVP questionnaire
Mean Manifest Refraction (Sphere)	Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative	Manifest refraction was performed under photopic lighting conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean.
Mean Manifest Refraction (Cylinder)	Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative	Manifest refraction was performed under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean.
Mean Laser Treatment Time	Day 0 (surgery)	Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds.
Percent Response by Category: "My Vision Is a Concern in My Daily Life"	Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative	As recorded by the subject on the RSVP questionnaire
Percent Response by Category: "Driving at Night"	Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative	As recorded by the subject on the RSVP questionnaire, where 0 is "Not applicable", 1 is "No difficulty at all", 2 is "A little difficulty", 3 is "Moderate difficulty", 4 is "Severe difficulty" and 5 is "So much difficulty that I did not do the activity with this alternative".