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Subjects will undergo SMILE surgery in one eye and LASIK surgery in their other eye to correct myopia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMILE | Active Comparator | SMILE surgery |
|
| Wavefront-guided LASIK | Active Comparator | Wavefront-guided LASIK |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMILE | Procedure | SMILE surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better | ETDRS testing lane | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity | ETDRS testing lane | One year |
| Aberrometry Measurements | Increase in total higher order RMS (root mean squared) by greater than 0.5 microns |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward E Manche, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute at Stanford | Palo Alto | California | 94303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34788593 | Result | 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. | |
| 36539217 | Derived | Ma 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. |
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Enrolled participants were to receive SMILE surgery in one eye and LASIK surgery in their fellow eye
| ID | Title | Description |
|---|---|---|
| FG000 | SMILE | SMILE surgery |
| FG001 | Wavefront-guided LASIK | Wavefront-guided LASIK |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants receive SMILE surgery in one eye and Wavefront-guided LASIK in the fellow eye. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better | ETDRS testing lane | Participants who completed 12 month follow-up | Posted | Number | percentage of participant eyes | One year | Eyes | Eyes |
|
|
12 months
Adverse events are reported per participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SMILE | SMILE surgery | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unable to remove SMILE lenticule | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward E. Manche | Stanford University School of Medcine | 6507255765 | edward.manche@stanford.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 6, 2020 | Nov 24, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020731 | Keratomileusis, Laser In Situ |
| ID | Term |
|---|---|
| D048988 | Corneal Surgery, Laser |
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| LASIK |
| Procedure |
LASIK surgery |
|
| One year |
| Patient Satisfaction | Percentage of patients satisfied with surgery. Patients were asked yes or no. | One year |
| Change in Corneal Sensation | A decrease in corneal sensation of more than 4 cm as measured by Cochet-Bonnet Aesthesiometry | 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. | One year |
| Analysis of Astigmatism | Participant eyes with an increase in astigmatism of greater than 1.0 diopter | One year |
| Anterior Segment Ocular Coherence Topography Analysis | Humphrey Visante AS OCT | One year |
| Predictability | Number of eyes within +/- 0.5 and +/- 1.00 diopter of the intended correction | One year |
| Stability | Change in refractive error greater than one diopter over 1 to 12 months | One year |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
| Eyes |
|
|
| Secondary | Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity | ETDRS testing lane | Participants who completed the 12 month follow-up | Posted | Count of Units | Eyes | One year | Eyes | Eyes |
|
|
|
| Secondary | Aberrometry Measurements | Increase in total higher order RMS (root mean squared) by greater than 0.5 microns | Participants who completed 12 months follow-up | Posted | Count of Units | Eyes | One year | Eyes | Eyes |
|
|
|
| Secondary | Patient Satisfaction | Percentage of patients satisfied with surgery. Patients were asked yes or no. | Participants who completed 12 months follow-up | Posted | Count of Participants | Participants | One year |
|
|
|
| Secondary | Change in Corneal Sensation | A decrease in corneal sensation of more than 4 cm as measured by Cochet-Bonnet Aesthesiometry | Participants who completed 12 months follow-up | Posted | Count of Units | Eyes | One year | Eyes | 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. | Patients who completed 12 months follow-up | Posted | Count of Participants | Participants | One year |
|
|
|
| Secondary | Analysis of Astigmatism | Participant eyes with an increase in astigmatism of greater than 1.0 diopter | Participants with 12 months follow-up | Posted | Count of Units | Eyes | One year | Eyes | Eyes |
|
|
|
| Secondary | Anterior Segment Ocular Coherence Topography Analysis | Humphrey Visante AS OCT | The outcome could not be analyzed because the data were corrupted | Posted | One year |
|
|
| Secondary | Predictability | Number of eyes within +/- 0.5 and +/- 1.00 diopter of the intended correction | Participants who completed 12 months follow-up | Posted | Count of Units | Eyes | One year | Eyes | Eyes |
|
|
|
| Secondary | Stability | Change in refractive error greater than one diopter over 1 to 12 months | Participants who completed twelve months follow-up | Posted | Count of Units | Eyes | One year | Eyes | Eyes |
|
|
|
| 44 |
| 0 |
| 44 |
| 1 |
| 44 |
| EG001 | Wavefront-guided LASIK | Wavefront-guided LASIK | 0 | 44 | 0 | 44 | 0 | 44 |
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| D013514 |
| Surgical Procedures, Operative |
| D000074431 | Keratectomy |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |