WaveLight® Refractive Myopic Study
This study is currently recruiting participants.
Verified October 2013 by Alcon Research
Information provided by (Responsible Party):
First received: September 10, 2013
Last updated: October 30, 2013
Last verified: October 2013
The purpose of this study is to evaluate outcomes of subjects undergoing myopic treatments using the WaveLight® Refractive Suite (Excimer EX500 and Femtosecond FS200 laser).
Device: Wavelight® Refractive Suite
Procedure: LASIK surgery
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Global, Multi-Center Study for the Evaluation of Outcomes on Subjects Undergoing Myopic Treatments Using the WaveLight® Refractive Suite|
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Uncorrected visual acuity (UCVA) [ Time Frame: Month 1 ] [ Designated as safety issue: No ]UCVA (ie, without spectacles) will be performed at a distance of four meters. UCVA is measured in logMAR (minimum angle of resolution), with a lower logMAR indicating better visual acuity.
Secondary Outcome Measures:
- Corneal flap thickness as assessed by ocular coherence tomography (OCT) [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]The thickness of the corneal flap will be assessed by OCT (ie, an imaging method using light to capture three-dimensional images). Corneal flap thickness is measured in microns.
- Manifest refraction per standard of care [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]A series of test lenses in graded powers will be used to determine which corrective lenses provide the sharpest, clearest vision. Manifest refraction is measured in diopters.
- Total treatment time as documented in the log files [ Time Frame: Day 0 (surgery) ] [ Designated as safety issue: No ]Total treatment time with Excimer EX500 and Femtosecond FS200 lasers will be measured in seconds and minutes.
- Spectacle independence as reported on the RSVP Questionnaire for Quality of Life and Retreatment [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]The Refractive Status and Vision Profile (RSVP) Questionnaire measures self-reported vision-related health status in persons with refractive error.
- Contrast Acuity [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]Contrast acuity (ie, a measurement of the ability to see between different shades of gray from the background) will be assessed in accordance with the manufacturer's guidelines. Contrast acuity is measured in logMAR, with a lower logMAR indicating better contrast acuity.
- Total root square mean (RMS) as determined by wavefront aberrometry [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]Wavefront aberrometry measures the eye's image-forming quality and optical abnormalities and how visual acuity is affected. Total RMS (ie, the overall magnitude of all the eye's refractive errors) will be assessed using a commercially available system. Total RMS is measured in 0.01 microns.
- Corneal curvature as measured by keratometry [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]Corneal curvature will be assessed using a commercially available system. Corneal curvature is measured in diopters.
- Wavefront optimization profile (WFO) as determined by wavefront aberrometry [ Time Frame: Up to Month 6 ] [ Designated as safety issue: No ]Wavefront aberrometry measures the eye's image-forming quality and optical abnormalities and how visual acuity is affected. WFO profile will be assessed using a commercially available system.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: WaveLight® Refractive Suite
LASIK surgery (laser in situ keratomileusis) per standard care of treatment and medication
Device: Wavelight® Refractive Suite
Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablationProcedure: LASIK surgery
Surgical procedure for treating refractive error based on corneal reshaping
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01941498
|Contact: Alcon Call Centerfirstname.lastname@example.org|
|United States, Texas|
|Contact Alcon Call Center for Trial Locations||Recruiting|
|Fort Worth, Texas, United States, 76134|
Sponsors and Collaborators
|Study Director:||Stefani Mulligan, MS||Alcon Research|