Evidence database / Studies / ang-2020-randomized-lasik-smile
HIGH evidenceRCTVerified evidence
Randomized Clinical Trial Comparing Femtosecond LASIK and Small-Incision Lenticule Extraction
Ang M, Farook M, Htoon HM, Mehta JS · Ophthalmology · 2020
140enrolled patients*
140enrolled eyes*
2structured arms
365maximum standardized days follow-up
* Descriptive sum of reported arm counts. “≥” indicates that one or more arm counts were not reported; missing values are not treated as zero.
Study arm
SMILE
SMILEVisuMax Femtosecond Laser
Population
- Patients
- 70
- Eyes
- 70
- Bilateral treatment
- No
- Age range
- Not reported
- Sphere range
- Not reported
- Cylinder range
- Not reported
- Spherical equivalent
- Not reported
- Corneal thickness
- Not reported
Eligibility definition
Inclusion
Myopia or myopic astigmatism eligible for paired-eye refractive surgery.
Exclusion
Not structured
Reported outcomes by follow-up
| Outcome | Follow-up | Follow-up sample | Result | Reported fraction | Provenance |
|---|---|---|---|---|---|
| UDVA 20/20 or better efficacy | 3 months | 70 eyes | 84.0% | denominator: 70 eyes | VERIFIED |
| Refraction within ±1.00 D efficacy | 3 months | 70 eyes | 99.0% | denominator: 70 eyes | VERIFIED |
| Efficacy index efficacy | 3 months | 70 eyes | 0.97 | Not reported | VERIFIED |
| Safety index safety | 3 months | 70 eyes | 1.10 | Not reported | VERIFIED |
| UDVA 20/20 or better efficacy | 12 months | 70 eyes | 85.0% | denominator: 70 eyes | VERIFIED |
| Refraction within ±1.00 D efficacy | 12 months | 70 eyes | 99.0% | denominator: 70 eyes | VERIFIED |
| Safety index safety | 12 months | 70 eyes | 1.15 | Not reported | VERIFIED |
Complications
No structured complication observations are available for this arm. This means “not reported in this dataset,” not zero complications.
Study arm
Femtosecond LASIK
LASIKWaveLight EX500
Population
- Patients
- 70
- Eyes
- 70
- Bilateral treatment
- No
- Age range
- Not reported
- Sphere range
- Not reported
- Cylinder range
- Not reported
- Spherical equivalent
- Not reported
- Corneal thickness
- Not reported
Eligibility definition
Inclusion
Myopia or myopic astigmatism eligible for paired-eye refractive surgery.
Exclusion
Not structured
Reported outcomes by follow-up
| Outcome | Follow-up | Follow-up sample | Result | Reported fraction | Provenance |
|---|---|---|---|---|---|
| UDVA 20/20 or better efficacy | 3 months | 70 eyes | 87.0% | denominator: 70 eyes | VERIFIED |
| Refraction within ±1.00 D efficacy | 3 months | 70 eyes | 97.0% | denominator: 70 eyes | VERIFIED |
| Efficacy index efficacy | 3 months | 70 eyes | 0.99 | Not reported | VERIFIED |
| Safety index safety | 3 months | 70 eyes | 1.10 | Not reported | VERIFIED |
| UDVA 20/20 or better efficacy | 12 months | 70 eyes | 83.0% | denominator: 70 eyes | VERIFIED |
| Refraction within ±1.00 D efficacy | 12 months | 70 eyes | 99.0% | denominator: 70 eyes | VERIFIED |
| Safety index safety | 12 months | 70 eyes | 1.15 | Not reported | VERIFIED |
Complications
No structured complication observations are available for this arm. This means “not reported in this dataset,” not zero complications.