MyopiaNCT03067077
A Prospective, Contralateral, Eye to Eye Comparison of SMILE Surgery to LASIK Surgery
A study testing SMILE and LASIK in people with Myopia, run by Stanford University at 1 site in United States.
Trial summary
Subjects will undergo SMILE surgery in one eye and LASIK surgery in their other eye to correct myopia. Read more about this study
- Who is it for?
- Ages 22 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- SMILE and LASIK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2017to 15 Mar 2021
- 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 22 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects age 22 and older with healthy eyes. Nearsightedness between -0.75 diopters and -8.00 diopters.
- Subjects with up to 3.00 diopters of astigmatism.
Who cannot join
- Subjects under the age of 22.
- Subjects with excessively thin corneas.
- Subjects with topographic evidence of keratoconus.
- Subjects with ectatic eye disorders.
- Subjects with autoimmune diseases.
- Subjects who are pregnant or nursing.
Show all 9Show fewer
- Subjects must have similar levels of nearsightedness in each eye. They can not be more than 1.5 diopter of difference between eyes.
- Subjects with 3.25 or more diopters of astigmatism
- Subjects must have similar levels of astigmatism in each eye. They can not have more than 0.50 diopters of difference between eyes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Byers Eye Institute at Stanford
Palo Alto, California, 94303
About this study
Official title: A Prospective, Randomized Comparison of SMILE Surgery to Wavefront-guided LASIK Surgery
Subjects will undergo SMILE surgery in one eye and LASIK surgery in their other eye to correct myopia.
Read the detailed description
Subjects will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the subject from the study, then we will inform the patient and make an appropriate referral. if the subject is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. Subjects will undergo bilateral simultaneous eye surgery. Which eye is treated with the WFG-LASIK and which eye is treated with SMILE will be randomized so there is a 50% chance for either eye to receive one treatment. Subjects will be seen on the day of surgery, post op day one, one week, one month, three months, six months and one year. Subjects will receive topical antibiotics in each eye for one week following the procedure. Subjects will receive topical steroid ophthalmic drops for one week after treatment. Subjects will also receive topical antibiotic ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of subjects undergoing LASIK and SMILE surgery.
- Conditions
- Myopia
- Being tested
- SMILE, LASIK
- Keywords
- SMILE, LASIK, Myopia, Wavefront-guided
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMILEProcedure or surgery
SMILE surgery
LASIKProcedure or surgery
LASIK surgery
| Study group | Role | What they receive |
|---|---|---|
| SMILE | Active comparator | SMILE surgery Receives: Procedure: SMILE; Procedure: LASIK |
| Wavefront-guided LASIK | Active comparator | Wavefront-guided LASIK Receives: Procedure: SMILE; Procedure: LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better
ETDRS testing lane
Measured: One year
Secondary outcomes (9)
Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity
ETDRS testing lane
Measured: One year
Aberrometry Measurements
Increase in total higher order RMS (root mean squared) by greater than 0.5 microns
Measured: One year
Patient Satisfaction
Percentage of patients satisfied with surgery. Patients were asked yes or no.
Measured: One year
Change in Corneal Sensation
A decrease in corneal sensation of more than 4 cm as measured by Cochet-Bonnet Aesthesiometry
Measured: One year
Dry Eye Symptoms as Measured by OSDI Index
Worsening of ocular surface disease index (OSDI) score of greater than 25. The overall OSDI score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.
Measured: One year
Analysis of Astigmatism
Participant eyes with an increase in astigmatism of greater than 1.0 diopter
Measured: One year
Anterior Segment Ocular Coherence Topography Analysis
Humphrey Visante AS OCT
Measured: One year
Predictability
Number of eyes within +/- 0.5 and +/- 1.00 diopter of the intended correction
Measured: One year
Stability
Change in refractive error greater than one diopter over 1 to 12 months
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start12 Mar 2017
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
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 (2)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward E. Manche, Stanford University
- Investigators
- Edward E Manche, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067077
- Sponsor's protocol ID
- 39587
- Status last verified
- Jan 2022
- First submitted
- 16 Feb 2017
- Last updated
- 2 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chiang B, Valerio GS, Manche EE. Prospective, Randomized Contralateral Eye Comparison of Wavefront-Guided Laser In Situ Keratomileusis and Small Incision Lenticule Extraction Refractive Surgeries. Am J Ophthalmol. 2022 May;237:211-220. doi: 10.1016/j.ajo.2021.11.013. Epub 2021 Nov 14.
PubMed 34788593Ma KK, Manche EE. Patient-reported quality of vision in a prospective randomized contralateral-eye trial comparing LASIK and small-incision lenticule extraction. J Cataract Refract Surg. 2023 Apr 1;49(4):348-353. doi: 10.1097/j.jcrs.0000000000001127.
PubMed 36539217
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Comparison of SMILE Surgery to Wavefront-guided LASIK Surgery
- ClinicalTrials.gov ID
- NCT03067077
- Acronym / sponsor ID
- 39587
- Conditions
- Myopia
- Keywords
- SMILE, LASIK, Myopia, Wavefront-guided
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 12 Mar 2017 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Posted 2 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects will undergo SMILE surgery in one eye and LASIK surgery in their other eye to correct myopia.
Detailed description
Subjects will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the subject from the study, then we will inform the patient and make an appropriate referral. if the subject is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. Subjects will undergo bilateral simultaneous eye surgery. Which eye is treated with the WFG-LASIK and which eye is treated with SMILE will be randomized so there is a 50% chance for either eye to receive one treatment. Subjects will be seen on the day of surgery, post op day one, one week, one month, three months, six months and one year. Subjects will receive topical antibiotics in each eye for one week following the procedure. Subjects will receive topical steroid ophthalmic drops for one week after treatment. Subjects will also receive topical antibiotic ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of subjects undergoing LASIK and SMILE surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMILE | Active comparator | Procedure: SMILE, Procedure: LASIKSMILE surgery |
| Wavefront-guided LASIK | Active comparator | Procedure: SMILE, Procedure: LASIKWavefront-guided LASIK |
Who may qualify
- Ages
- 22 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects age 22 and older with healthy eyes. Nearsightedness between -0.75 diopters and -8.00 diopters.
- Subjects with up to 3.00 diopters of astigmatism.
Key exclusion criteria (9 listed)
- Subjects under the age of 22.
- Subjects with excessively thin corneas.
- Subjects with topographic evidence of keratoconus.
- Subjects with ectatic eye disorders.
- Subjects with autoimmune diseases.
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 |
|---|---|---|
| SMILESMILE surgery | Procedure or surgery | SMILE, Wavefront-guided LASIK |
| LASIKLASIK surgery | Procedure or surgery | SMILE, Wavefront-guided LASIK |
Primary outcome
Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better
Time frame: One year
ETDRS testing lane
9 secondary outcomes
Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity
Time frame: One year
Aberrometry Measurements
Time frame: One year
Patient Satisfaction
Time frame: One year
Change in Corneal Sensation
Time frame: One year
Dry Eye Symptoms as Measured by OSDI Index
Time frame: One year
Analysis of Astigmatism
Time frame: One year
Anterior Segment Ocular Coherence Topography Analysis
Time frame: One year
Predictability
Time frame: One year
Stability
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34788593Chiang B, Valerio GS, Manche EE. Prospective, Randomized Contralateral Eye Comparison of Wavefront-Guided Laser In Situ Keratomileusis and Small Incision Lenticule Extraction Refractive Surgeries. Am J Ophthalmol. 2022 May;237:211-220. doi: 10.1016/j.ajo.2021.11.013. Epub 2021 Nov 14.
- Derived from this study: PubMed 36539217Ma KK, Manche EE. Patient-reported quality of vision in a prospective randomized contralateral-eye trial comparing LASIK and small-incision lenticule extraction. J Cataract Refract Surg. 2023 Apr 1;49(4):348-353. doi: 10.1097/j.jcrs.0000000000001127.
- 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.
Edward E Manche, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMILE and LASIK in people with Myopia, run by Stanford University 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 2 inclusion and 9 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 2 Feb 2022. 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 2 Feb 2022). 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 Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better (time frame: One year). 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 NCT03067077, which also lists 2 linked publications.
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 2 Feb 2022.