MyopiaNCT02987660
Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax
A study testing Topography Guided LASIK, Small Incision Lenticular Extraction and WaveLight EX500 Excimer Laser System in people with Myopia and Astigmatism, run by Alcon, a Novartis Company at 1 site in France.
Trial summary
The purpose of this study is to compare Topography Guided Laser In Situ Keratomileusis (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for the treatment of myopia with astigmatism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Topography Guided LASIK, Small Incision Lenticular Extraction and WaveLight EX500 Excimer Laser System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2017to 26 Jul 2017
- 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
- Subjects in Singapore must be 21 years of age or older and subjects in Korea must be upon completion of 19 years of age or older due to local regulations;
- Able to comprehend and sign an informed consent form;
- Willing and able to complete all postoperative visits;
- Myopia requiring (a) refractive error correction of -0.5 to -8.0 D optical infinity adjusted manifest refraction sphere with (b) astigmatism correction of -0.75 to -5.0 D manifest refraction cylinder and (c) at least 0.75 D of corneal astigmatism.
- Intended treatment targeted for emmetropia;
- Preoperative best-corrected visual acuity (BCVA) of 0 logMAR or better;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Pregnant or lactating, current or planned, during the course of the study;
- Dry eye;
- Corneal disease;
- Diagnosis of advanced glaucoma;
- Uncontrolled diabetes;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare Topography Guided Laser In Situ Keratomileusis (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for the treatment of myopia with astigmatism.
- Conditions
- Myopia, Astigmatism
- Being tested
- Topography Guided LASIK, Small Incision Lenticular Extraction, WaveLight EX500 Excimer Laser System, VisuMax Surgical Laser
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topography Guided LASIKProcedure or surgery
Corneal surgery for refractive error correction
Small Incision Lenticular ExtractionProcedure or surgery
Also called SMILE
Refractive surgical procedure for the correction of myopia with or without astigmatism
WaveLight EX500 Excimer Laser SystemDevice
As used for corneal stroma ablation (refractive error correction). The treatment is intended to last the subject's lifetime.
VisuMax Surgical LaserDevice
As used for lenticule creation/removal (refractive error correction). The treatment is intended to last the subject's lifetime.
| Study group | Role | What they receive |
|---|---|---|
| LASIK with EX500 | Experimental | Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery Receives: Procedure: Topography Guided LASIK; Device: WaveLight EX500 Excimer Laser System |
| SMILE with VisuMax | Active comparator | Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery Receives: Procedure: Small Incision Lenticular Extraction; Device: VisuMax Surgical Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months
Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.
Measured: Month 3
Secondary outcomes (2)
Mean Manifest Refraction Cylinder at 3 Months
Manifest refraction cylinder was measured monocularly at 3 or 4 meters under photopic lighting conditions using a phoropter and ETDRS chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.
Measured: Month 3
Mean Uncorrected Visual Acuity (UCVA) at 3 Months
Uncorrected (without spectacles or other visual corrective devices) Visual Acuity (UCVA) testing was conducted monocularly in photopic conditions without glare at 3 or 4 meters. Visual Acuity (VA) is measured in "logarithm of the minimum angle of resolution" (logMAR). A lower logMAR value indicates better visual acuity. The Precision Vision illuminator cabinets and ETDRS charts were used. For subjects who could not read English letters, a numerical, Tumbling E logMAR chart was used. Since the study was terminated early, inferential statistics could not be completed.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start3 Mar 2017
- Primary completion26 Jul 2017
- Study completion26 Jul 2017
Why it stopped: management decision; non patient safety related reason
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 MyopiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon, a Novartis Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alcon, A Novartis Division, Study director, Alcon, A Novartis Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987660
- Sponsor's protocol ID
- RFL605-P001
- Status last verified
- Jul 2018
- First submitted
- 7 Dec 2016
- Last updated
- 14 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax
- ClinicalTrials.gov ID
- NCT02987660
- Acronym / sponsor ID
- RFL605-P001
- Conditions
- Myopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: management decision; non patient safety related reason
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Alcon, a Novartis CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 26 Jul 2017 (actual)
- Study completion
- 26 Jul 2017 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Posted 14 Jan 2019
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 compare Topography Guided Laser In Situ Keratomileusis (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for the treatment of myopia with astigmatism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LASIK with EX500 | Experimental | Procedure: Topography Guided LASIK, Device: WaveLight EX500 Excimer Laser SystemTopography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery |
| SMILE with VisuMax | Active comparator | Procedure: Small Incision Lenticular Extraction, Device: VisuMax Surgical LaserSmall incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects in Singapore must be 21 years of age or older and subjects in Korea must be upon completion of 19 years of age or older due to local regulations;
- Able to comprehend and sign an informed consent form;
- Willing and able to complete all postoperative visits;
- Myopia requiring (a) refractive error correction of -0.5 to -8.0 D optical infinity adjusted manifest refraction sphere with (b) astigmatism correction of -0.75 to -5.0 D manifest refraction cylinder and (c) at least 0.75 D of corneal astigmatism.
- Intended treatment targeted for emmetropia;
Key exclusion criteria (6 listed)
- Pregnant or lactating, current or planned, during the course of the study;
- Dry eye;
- Corneal disease;
- Diagnosis of advanced glaucoma;
- Uncontrolled diabetes;
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 |
|---|---|---|
| Topography Guided LASIKCorneal surgery for refractive error correction | Procedure or surgery | LASIK with EX500 |
| Small Incision Lenticular ExtractionAlso: SMILERefractive surgical procedure for the correction of myopia with or without astigmatism | Procedure or surgery | SMILE with VisuMax |
| WaveLight EX500 Excimer Laser SystemAs used for corneal stroma ablation (refractive error correction). The treatment is intended to last the subject's lifetime. | Device | LASIK with EX500 |
| VisuMax Surgical LaserAs used for lenticule creation/removal (refractive error correction). The treatment is intended to last the subject's lifetime. | Device | SMILE with VisuMax |
Primary outcome
Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months
Time frame: Month 3
Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.
2 secondary outcomes
Mean Manifest Refraction Cylinder at 3 Months
Time frame: Month 3
Mean Uncorrected Visual Acuity (UCVA) at 3 Months
Time frame: Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- 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.
Alcon, A Novartis Division study director
Alcon, A Novartis Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topography Guided LASIK, Small Incision Lenticular Extraction and WaveLight EX500 Excimer Laser System in people with Myopia and Astigmatism, run by Alcon, a Novartis Company at 1 site in France.
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 6 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: stopped early, as of the sponsor's last update on 14 Jan 2019. 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 France. 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 14 Jan 2019). 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?
Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months (time frame: Month 3). 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 14 Jan 2019.