MyopiaFS200NCT02060461
LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser
A study testing FS200 femtosecond laser LASIK and IntraLase femtosecond laser LASIK in people with Myopia, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The objective of this study is to evaluate the visual outcome, accuracy, predictability and complications of LASIK flap creation using the Alcon Wavelight FS200 Femtosecond laser and compare these results to those obtained using current IntraLase FS60 Femtosecond laser. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- FS200 femtosecond laser LASIK and IntraLase femtosecond laser LASIK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Sep 2016
- 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
- All patients with ametropia (Spherical, spherocylindrical, presbyopic) suitable for treatment by LASIK, including different target refractions (Plano or Monovision).
Who cannot join
- Patients unsuitable for LASIK procedure because of an estimated residual stromal bed < 300 microns after calculation of the ablation (Corneal thickness - flap thickness - simulated stromal ablation for the desired correction).
- Patients unsuitable for LASIK due suspicious topography for ectasia, form frust keratoconus or unstable ( more than 0.50 diopter change in sphere or cylinder in the last year) refraction.
- Patients with amblyopia or any eye disease that might limit the visual recovery.
- Patients younger than 18 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser: 3 Months Follow-up of Initial US Clinical Series
The objective of this study is to evaluate the visual outcome, accuracy, predictability and complications of LASIK flap creation using the Alcon Wavelight FS200 Femtosecond laser and compare these results to those obtained using current IntraLase FS60 Femtosecond laser. The primary outcome to be evaluated is the flap thickness accuracy.
Read the detailed description
Laser in situ keratomileusis (LASIK) is a method for treating myopia, hyperopia and astigmatism. In LASIK, the cornea is reshaped to focus images more clearly on the retina without the aid of glasses or contact lenses. LASIK involves two steps: creation of a corneal flap, which can be performed by a mechanical microkeratome or a femtosecond laser, and reshaping of the cornea by another laser, an excimer laser.
The accuracy of the LASIK flap thickness is a key safety consideration to reduce the likelihood of complications following LASIK. Femtosecond laser technology has significantly improved the predictability of LASIK flap dimensions while supporting similar visual acuity results.
The Alcon FS200 femtosecond laser is approved for human use by the United States Food and Drug Administration and was recently released in the US market. This study will directly compare outcomes of LASIK performed with this newer laser to those performed with the AMO IntraLase femtosecond laser.
- Conditions
- Myopia
- Being tested
- FS200 femtosecond laser LASIK, IntraLase femtosecond laser LASIK
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FS200 femtosecond laser LASIKDevice
Also called Alcon FS200 femtosecond laser
IntraLase femtosecond laser LASIKDevice
Also called AMO IntraLase femtosecond laser
| Study group | Role | What they receive |
|---|---|---|
| FS200 femtosecond laser LASIK | Experimental | LASIK flap created with an FS200 femtosecond laser system Receives: Device: FS200 femtosecond laser LASIK |
| IntraLase femtosecond laser LASIK | Experimental | LASIK flap created with an IntraLase femtosecond laser system Receives: Device: IntraLase femtosecond laser LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of LASIK Flap Thickness
Central LASIK flap thickness for each femtosecond laser. Each treatment was set for a 110 micrometer thick flap.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startAug 2012
- Primary completionSep 2015
- Study completionSep 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Model description
- Contralateral eye study
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- William J Dupps, MD, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060461
- Sponsor's protocol ID
- 11-744
- Acronym
- FS200
- Status last verified
- Feb 2018
- First submitted
- 16 Dec 2013
- Last updated
- 23 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rocha KM, Krueger RR. Spectral-domain optical coherence tomography epithelial and flap thickness mapping in femtosecond laser-assisted in situ keratomileusis. Am J Ophthalmol. 2014 Aug;158(2):293-301.e1. doi: 10.1016/j.ajo.2014.04.012. Epub 2014 Apr 30.
PubMed 24792107
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond Laser: 3 Months Follow-up of Initial US Clinical Series
- ClinicalTrials.gov ID
- NCT02060461
- Acronym / sponsor ID
- FS200 / 11-744
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Aug 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Posted 23 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the visual outcome, accuracy, predictability and complications of LASIK flap creation using the Alcon Wavelight FS200 Femtosecond laser and compare these results to those obtained using current IntraLase FS60 Femtosecond laser. The primary outcome to be evaluated is the flap thickness accuracy.
Detailed description
Laser in situ keratomileusis (LASIK) is a method for treating myopia, hyperopia and astigmatism. In LASIK, the cornea is reshaped to focus images more clearly on the retina without the aid of glasses or contact lenses. LASIK involves two steps: creation of a corneal flap, which can be performed by a mechanical microkeratome or a femtosecond laser, and reshaping of the cornea by another laser, an excimer laser.
The accuracy of the LASIK flap thickness is a key safety consideration to reduce the likelihood of complications following LASIK. Femtosecond laser technology has significantly improved the predictability of LASIK flap dimensions while supporting similar visual acuity results.
The Alcon FS200 femtosecond laser is approved for human use by the United States Food and Drug Administration and was recently released in the US market. This study will directly compare outcomes of LASIK performed with this newer laser to those performed with the AMO IntraLase femtosecond laser.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Contralateral eye study
| Arm | Type | Receives |
|---|---|---|
| FS200 femtosecond laser LASIK | Experimental | Device: FS200 femtosecond laser LASIKLASIK flap created with an FS200 femtosecond laser system |
| IntraLase femtosecond laser LASIK | Experimental | Device: IntraLase femtosecond laser LASIKLASIK flap created with an IntraLase femtosecond laser system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with ametropia (Spherical, spherocylindrical, presbyopic) suitable for treatment by LASIK, including different target refractions (Plano or Monovision).
Key exclusion criteria (4 listed)
- Patients unsuitable for LASIK procedure because of an estimated residual stromal bed < 300 microns after calculation of the ablation (Corneal thickness - flap thickness - simulated stromal ablation for the desired correction).
- Patients unsuitable for LASIK due suspicious topography for ectasia, form frust keratoconus or unstable ( more than 0.50 diopter change in sphere or cylinder in the last year) refraction.
- Patients with amblyopia or any eye disease that might limit the visual recovery.
- Patients younger than 18 years old.
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 |
|---|---|---|
| FS200 femtosecond laser LASIKAlso: Alcon FS200 femtosecond laser | Device | FS200 femtosecond laser LASIK |
| IntraLase femtosecond laser LASIKAlso: AMO IntraLase femtosecond laser | Device | IntraLase femtosecond laser LASIK |
Primary outcome
Evaluation of LASIK Flap Thickness
Time frame: 3 months
Central LASIK flap thickness for each femtosecond laser. Each treatment was set for a 110 micrometer thick flap.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24792107Rocha KM, Krueger RR. Spectral-domain optical coherence tomography epithelial and flap thickness mapping in femtosecond laser-assisted in situ keratomileusis. Am J Ophthalmol. 2014 Aug;158(2):293-301.e1. doi: 10.1016/j.ajo.2014.04.012. Epub 2014 Apr 30.
- Individual participant dataSharing planned: No
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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.
William J Dupps, MD, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FS200 femtosecond laser LASIK and IntraLase femtosecond laser LASIK in people with Myopia, run by The Cleveland Clinic at 1 site in United States.
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 1 inclusion and 4 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 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 23 Mar 2018). 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?
Evaluation of LASIK Flap Thickness (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02060461, which also lists 1 linked publication.
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 23 Mar 2018.