Refractive ErrorNCT01941498
WaveLight® Refractive Myopic Study
A study testing Wavelight® Refractive Suite and LASIK surgery in people with Refractive Error, run by Alcon Research.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Error
- What is being tested?
- Wavelight® Refractive Suite and LASIK surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
About this study
Official title: A Prospective, Global, Multi-Center Study for the Evaluation of Outcomes on Subjects Undergoing Myopic Treatments Using the WaveLight® Refractive Suite
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).
- Conditions
- Refractive Error
- Being tested
- Wavelight® Refractive Suite, LASIK surgery
- Keywords
- nearsighted, farsighted, astigmatism, LASIK, refractive surgery, WaveLight
- Medical subject headings
- Refractive Errors, Myopia, Hyperopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wavelight® Refractive SuiteDevice
Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation
LASIK surgeryProcedure or surgery
Surgical procedure for treating refractive error based on corneal reshaping
| Study group | Role | What they receive |
|---|---|---|
| WaveLight Refractive Suite | Experimental | LASIK surgery (laser in situ keratomileusis) per standard of care Receives: Device: Wavelight® Refractive Suite; Procedure: LASIK surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 1
Secondary outcomes (13)
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.
Measured: Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative
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.
Measured: Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
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.
Measured: Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
Mean Laser Treatment Time
Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds.
Measured: Day 0 (surgery)
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.
Measured: Day 0 (surgery)
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).
Measured: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
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.
Measured: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
Percent Response by Category: "I Worry About my Vision"
As recorded by the subject on the RSVP questionnaire
Measured: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
Percent Response by Category: "My Vision Is a Concern in My Daily Life"
As recorded by the subject on the RSVP questionnaire
Measured: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
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".
Measured: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
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.
Measured: Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
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.
Measured: Baseline (Day 0), Month 6 Postoperative
Corneal Curvature as Measured by Keratometry
Corneal curvature was assessed by a commercially available system and measured in diopters.
Measured: Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractive ErrorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Manager, GMA, Surgical, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941498
- Sponsor's protocol ID
- A01353
- Status last verified
- Oct 2015
- First submitted
- 10 Sep 2013
- Last updated
- 3 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Global, Multi-Center Study for the Evaluation of Outcomes on Subjects Undergoing Myopic Treatments Using the WaveLight® Refractive Suite
- ClinicalTrials.gov ID
- NCT01941498
- Acronym / sponsor ID
- A01353
- Conditions
- Refractive Error
- Keywords
- nearsighted, farsighted, astigmatism, LASIK, refractive surgery, WaveLight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Posted 11 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WaveLight Refractive Suite | Experimental | Device: Wavelight® Refractive Suite, Procedure: LASIK surgeryLASIK surgery (laser in situ keratomileusis) per standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wavelight® Refractive SuiteExcimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation | Device | WaveLight Refractive Suite |
| LASIK surgerySurgical procedure for treating refractive error based on corneal reshaping | Procedure or surgery | WaveLight Refractive Suite |
Primary outcome
Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA
Time frame: 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.
13 secondary outcomes
Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT
Time frame: Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative
Mean Manifest Refraction (Sphere)
Time frame: Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
Mean Manifest Refraction (Cylinder)
Time frame: Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
Mean Laser Treatment Time
Time frame: Day 0 (surgery)
Mean Total Laser Treatment Time
Time frame: Day 0 (surgery)
Mean Response: "Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"
Time frame: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
Percent Response by Category: "In the Past 4 Weeks, to See Far Away, I Wore..."
Time frame: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
Percent Response by Category: "I Worry About my Vision"
Time frame: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
Percent Response by Category: "My Vision Is a Concern in My Daily Life"
Time frame: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
Percent Response by Category: "Driving at Night"
Time frame: Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative
Mean Contrast Sensitivity (CS)
Time frame: Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
Wavefront Aberrometry
Time frame: Baseline (Day 0), Month 6 Postoperative
Corneal Curvature as Measured by Keratometry
Time frame: Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Manager, GMA, Surgical study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Wavelight® Refractive Suite and LASIK surgery in people with Refractive Error, run by Alcon Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA (time frame: Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.