Back to results

WaveLight® Refractive Flap Accuracy Study

Primary Purpose

Refractive Error

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

WaveLight® Refractive Suite

LASIK surgery

About this trial

This is an interventional treatment trial for Refractive Error focused on measuring nearsighted, astigmatism, LASIK, refractive surgery, WaveLight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WaveLight Refractive Suite

Arm Description

LASIK surgery (laser in situ keratomileusis) per standard of care

Outcomes

Primary Outcome Measures

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). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.

Secondary Outcome Measures

Incidence of Development of Opaque Bubble Layer (OBL)

OBL (the collection of gas bubbles during corneal flap creation) was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of participants with opaque bubble layer development during femtosecond flap creation.

Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap

The extent of OBL was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of flap with opaque bubble layer development during femtosecond flap creation.

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). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.

Uncorrected Visual Acuity (UCVA)

Visual acuity (VA) without spectacles or other visual corrective devices, was performed with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at a distance of 4 meters. UCVA was 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.

Best Corrected Visual Acuity (BCVA)

VA with the subjects's best spectacles or other visual corrective devices, was performed with an ETDRS chart set at a distance of 4 meters. BCVA was 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.

Manifest Refraction (Sphere)

A series of test lenses in graded powers was used to determine which corrective lenses provided the sharpest, clearest vision. Manifest refraction is measured in diopters. Each eye contributed individually to the analysis.

Manifest Refraction (Cylinder)

Mean Contrast Sensitivity (CS)

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. Both eyes contributed to the analysis.

Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT)

The diameter of the corneal flap was assessed by OCT (ie. an imaging method using light to capture three-dimensional images). Corneal flap is measured in millimeters.

Wavefront Aberrometry

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 trefoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology.

Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"

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).

Percent Response to "Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks"

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.

Percent Response by Category: "I Worry About my Vision"

As recorded by the subject on the RSVP questionnaire

Percent Response by Category: "My Vision is a Concern in my Daily Life"

As recorded by the subject on the RSVP questionnaire

Percent Response by Category: "Driving at Night"

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".

Corneal Curvature as Measured by Keratometry

Corneal curvature as assessed by a commercially available system and measured in diopters.

Flap Creation Time as Documented in the Log Files

The time to create the flap with FS200 Femtosecond Flap Creation System, measured in seconds.

Corneal Topography: Q-value

The Q-value (a measure of corneal asphericity) was assessed using a commercially available system. The Q-values are negative (-1 < Q < 0) for prolate corneas, in which the central curvature is steeper than the peripheral curvature, and positive (Q > 0) for oblate corneas, in which the central curvature is flatter than the peripheral curvature.

Corneal Topography: Anterior Chamber (AC) Volume

The AC volume (a measure of the shallowness of the anterior chamber) was assessed using a commercially available system. The lower the chamber volume, the more shallow the anterior chamber or the chamber angle.

Corneal Topography: Anterior Chamber (AC) Depth

The AC depth (axial distance between the anterior surface of the cornea and the anterior surface of the lens) was assessed using a commercially available system. A higher value represents a longer distance.

Corneal Topography: Angles

The angles (angular measurement of the space between the iris and the lens) were assessed using a commercially available system. The higher the value, the bigger the space.

Full Information

NCT ID

NCT01941485

First Posted

September 10, 2013

Last Updated

November 7, 2016

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01941485

Brief Title

WaveLight® Refractive Flap Accuracy Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 optical coherence tomography (OCT) anterior segment corneal measurements compared to pre-operative flap thickness target.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractive Error

Keywords

nearsighted, astigmatism, LASIK, refractive surgery, WaveLight

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

WaveLight Refractive Suite

Arm Type

Experimental

Arm Description

LASIK surgery (laser in situ keratomileusis) per standard of care

Intervention Type

Device

Intervention Name(s)

WaveLight® Refractive Suite

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

LASIK surgery

Intervention Description

Surgical procedure for treating refractive error based on corneal reshaping

Primary Outcome Measure Information:

Title

The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively

Description

Time Frame

Day 1 Postoperative

Secondary Outcome Measure Information:

Title

Incidence of Development of Opaque Bubble Layer (OBL)

Description

Time Frame

Operation/Surgery (Day 1)

Title

Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap

Description

Time Frame

Operation/Surgery (Day 1)

Title

The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively

Description

Time Frame

Month 1 Postoperative

Title

Uncorrected Visual Acuity (UCVA)

Description

Time Frame

Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative

Title

Best Corrected Visual Acuity (BCVA)

Description

Time Frame

Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative

Title

Manifest Refraction (Sphere)

Description

Time Frame

Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative

Title

Manifest Refraction (Cylinder)

Description

Time Frame

Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative

Title

Mean Contrast Sensitivity (CS)

Description

Time Frame

Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative

Title

Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT)

Description

The diameter of the corneal flap was assessed by OCT (ie. an imaging method using light to capture three-dimensional images). Corneal flap is measured in millimeters.

Time Frame

Operation/Surgery (Day 1), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative

Title

Wavefront Aberrometry

Description

Time Frame

Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative

Title

Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"

Description

Time Frame