WaveLight® Refractive Myopic Study

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Primary Purpose

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, farsighted, 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.
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.

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

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

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

Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT

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 Manifest Refraction (Sphere)

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)

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

Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds.

Mean Total Laser Treatment Time

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.

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 by Category: "In the Past 4 Weeks, to See Far Away, I Wore..."

As recorded by the subject on the RSVP questionnaire, where n/a means no use of glasses or contact lenses.

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".

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.

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

Corneal Curvature as Measured by Keratometry

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

Full Information

NCT ID

NCT01941498

First Posted

September 10, 2013

Last Updated

October 2, 2015

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01941498

Brief Title

WaveLight® Refractive Myopic Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

No

5. Study Description

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).

6. Conditions and Keywords

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

Refractive Error

Keywords

nearsighted, farsighted, 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

104 (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

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

Description

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.

Time Frame

Month 1

Secondary Outcome Measure Information:

Title

Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT

Description

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.

Time Frame

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

Title

Mean Manifest Refraction (Sphere)

Description

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.

Time Frame

Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative

Title

Mean Manifest Refraction (Cylinder)

Description

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.

Time Frame

Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative

Title

Mean Laser Treatment Time

Description

Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds.

Time Frame

Day 0 (surgery)

Title

Mean Total Laser Treatment Time

Description

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.

Time Frame

Day 0 (surgery)

Title

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

Description

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).

Time Frame