Myopia
Conditions
Keywords
SMILE, LASIK, Myopia, Wavefront-guided
Brief summary
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.
Interventions
PROCEDURESMILE
SMILE surgery
PROCEDURELASIK
LASIK surgery
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better | One year | ETDRS testing lane |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Segment Ocular Coherence Topography Analysis | One year | Humphrey Visante AS OCT |
| Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity | One year | ETDRS testing lane |
| Aberrometry Measurements | One year | Increase in total higher order RMS (root mean squared) by greater than 0.5 microns |
| Patient Satisfaction | One year | Percentage of patients satisfied with surgery. Patients were asked yes or no. |
| Analysis of Astigmatism | One year | Participant eyes with an increase in astigmatism of greater than 1.0 diopter |
| Dry Eye Symptoms as Measured by OSDI Index | One year | 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. |
| Predictability | One year | Number of eyes within +/- 0.5 and +/- 1.00 diopter of the intended correction |
| Stability | One year | Change in refractive error greater than one diopter over 1 to 12 months |
| Change in Corneal Sensation | One year | A decrease in corneal sensation of more than 4 cm as measured by Cochet-Bonnet Aesthesiometry |
Countries
United States
Participant flow
Recruitment details
Enrolled participants were to receive SMILE surgery in one eye and LASIK surgery in their fellow eye
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants receive SMILE surgery in one eye and Wavefront-guided LASIK in the fellow eye. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive surgery | 4 | 5 |
| Overall Study | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants |
| Race/Ethnicity, Customized Asian | 19 Participants |
| Race/Ethnicity, Customized Caucasian | 18 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants |
| Race/Ethnicity, Customized Indian | 4 Participants |
| Race/Ethnicity, Customized Pacific Islander | 1 Participants |
| Region of Enrollment United States | 44 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 44 |
| other Total, other adverse events | 1 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
Primary
Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better
ETDRS testing lane
Time frame: One year
Population: Participants who completed 12 month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SMILE | Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better | 94 percentage of participant eyes |
| Wavefront-guided LASIK | Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better | 83 percentage of participant eyes |
Secondary
Aberrometry Measurements
Increase in total higher order RMS (root mean squared) by greater than 0.5 microns
Time frame: One year
Population: Participants who completed 12 months follow-up
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| SMILE | Aberrometry Measurements | 0 Eyes |
| Wavefront-guided LASIK | Aberrometry Measurements | 0 Eyes |
Secondary
Analysis of Astigmatism
Participant eyes with an increase in astigmatism of greater than 1.0 diopter
Time frame: One year
Population: Participants with 12 months follow-up
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| SMILE | Analysis of Astigmatism | 0 Eyes |
| Wavefront-guided LASIK | Analysis of Astigmatism | 0 Eyes |
Secondary
Anterior Segment Ocular Coherence Topography Analysis
Humphrey Visante AS OCT
Time frame: One year
Population: The outcome could not be analyzed because the data were corrupted
Secondary
Change in Corneal Sensation
A decrease in corneal sensation of more than 4 cm as measured by Cochet-Bonnet Aesthesiometry
Time frame: One year
Population: Participants who completed 12 months follow-up
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| SMILE | Change in Corneal Sensation | 0 Eyes |
| Wavefront-guided LASIK | Change in Corneal Sensation | 0 Eyes |
Secondary
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.
Time frame: One year
Population: Patients who completed 12 months follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SMILE | Dry Eye Symptoms as Measured by OSDI Index | 0 Participants |
| Wavefront-guided LASIK | Dry Eye Symptoms as Measured by OSDI Index | 0 Participants |
Secondary
Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity
ETDRS testing lane
Time frame: One year
Population: Participants who completed the 12 month follow-up
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| SMILE | Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity | 0 Eyes |
| Wavefront-guided LASIK | Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity | 0 Eyes |
Secondary
Patient Satisfaction
Percentage of patients satisfied with surgery. Patients were asked yes or no.
Time frame: One year
Population: Participants who completed 12 months follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SMILE | Patient Satisfaction | 36 Participants |
| Wavefront-guided LASIK | Patient Satisfaction | 36 Participants |
Secondary
Predictability
Number of eyes within +/- 0.5 and +/- 1.00 diopter of the intended correction
Time frame: One year
Population: Participants who completed 12 months follow-up
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SMILE | Predictability | +/- 0.50 diopters | 30 Eyes |
| SMILE | Predictability | +/- 1.0 diopters | 36 Eyes |
| Wavefront-guided LASIK | Predictability | +/- 0.50 diopters | 34 Eyes |
| Wavefront-guided LASIK | Predictability | +/- 1.0 diopters | 37 Eyes |
Secondary
Stability
Change in refractive error greater than one diopter over 1 to 12 months
Time frame: One year
Population: Participants who completed twelve months follow-up
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| SMILE | Stability | 0 Eyes |
| Wavefront-guided LASIK | Stability | 0 Eyes |