WaveLight® Refractive Flap Accuracy Study

Refractive Error Clinical Trial

Official title:

A Prospective, Global, Multi-Center Study to Evaluate Longitudinal Flap Accuracy on Subjects Undergoing Myopic Refractive Surgery Using the WaveLight® Refractive Suite

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941485
• Other study ID #: A01354
• Status: Completed
• Phase: N/A
• First received: September 10, 2013
• Last updated: April 2, 2015
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 OCT anterior segment corneal measurements compared to pre-operative flap thickness target.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• WaveLight® Refractive Suite
Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation

Procedure:
• LASIK surgery
Surgical procedure for treating refractive error based on corneal reshaping

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively	The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness at Day 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images).	Day 1	No
Secondary	Opaque Bubble Layer (OBL) Development	OBL (ie, a complication of corneal flap creation) assessed by digital photo analysis.	Day 0 (operative day)	No
Secondary	The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively	The expected flap thickness as determined pre-operatively subtracted from the achieved flap thickness at Month 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images).	Month 1	No
Secondary	Uncorrected Visual Acuity (UCVA)	Visual acuity (VA) without spectacles or other visual corrective devices, assessed a distance of 4 meters and measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.	Up to Month 12	No
Secondary	Best Corrected Visual Acuity (BCVA) at Distance	VA with the participant's best spectacles or other visual corrective devices assessed at a distance of 4 meters and measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.	Up to Month 12	No
Secondary	Manifest Refraction	Manifest refraction as performed using visual acuity charts at a distance of 4 meters to document the sphere, cylinder and axis readings, measured in diopters.	Up to Month 12	No
Secondary	Contrast Acuity	Contrast acuity (ie, a measurement of the ability to see between different shades of gray from the background) assessed in accordance with the manufacturer's guidelines, measured in logCS. A higher logCS value indicates better contrast acuity.	Up to Month 12	No
Secondary	Corneal Flap Diameter	Diameter of the corneal flap as assessed by OCT and measured in microns.	Up to Month 12	No
Secondary	Wavefront Aberrometry	Wavefront error of the eye as measured with a commercially available system and recorded in microns.	Up to Month 12	No
Secondary	Quality of Life as Reported on RSVP Questionnaire	The Refractive Status and Vision Profile (RSVP) is a self-reported questionnaire used to measure vision-related health status in persons with refractive error.	Up to Month 12	No
Secondary	Corneal Curvature as Measured by Keratometry	Corneal curvature as assessed by a commercially available system and measured in diopters.	Up to Month 12	No
Secondary	Flap Creation Time	Treatment time with Femtosecond FS200 laser, measured in seconds.	Day 0 (operative day)	No
Secondary	Corneal Topography	Corneal topography as assessed by a commercially available system.	Up to Month 12	No