FDA pivotal clinical study of SMILE with the VisuMax Femtosecond Laser

Evidence database / Studies / fda-visumax-smile-pivotal

336enrolled patients*

336enrolled eyes*

1structured 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

VisuMax SMILE

SMILEVisuMax Femtosecond Laser

Population

Patients: 336
Eyes: 336
Bilateral treatment: No
Age range: 22 to 58 years
Sphere range: -10 to -1 D
Cylinder range: Not reported
Spherical equivalent: Not reported
Corneal thickness: Not reported

Eligibility definition

Inclusion
Age at least 22 years; spherical myopia from -1.00 D to -10.00 D; cylinder no more than -0.50 D; MRSE no more than -10.25 D; stable refraction; central corneal thickness at least 500 microns.

Exclusion
See FDA SSED pages 9-10 for the complete exclusion criteria.

Reported outcomes by follow-up

Outcome	Follow-up	Follow-up sample	Result	Reported fraction	Provenance
UDVA 20/20 or better efficacy	6 months	328 eyes	87.5%	287 / 328 eyes	VERIFIED Source · 23
MRSE within ±0.50 D predictability	6 months	328 eyes	93.0%	305 / 328 eyes	VERIFIED Source · 23
Refraction within ±1.00 D efficacy	6 months	328 eyes	98.5%	323 / 328 eyes	VERIFIED Source · 24
Lost at least 2 lines of CDVA safety	6 months	328 eyes	0%	0 / 329 eyes	VERIFIED Source · 15
UDVA 20/20 or better efficacy	12 months	310 eyes	88.1%	273 / 310 eyes	VERIFIED Source · 23
MRSE within ±0.50 D predictability	12 months	310 eyes	93.9%	291 / 310 eyes	VERIFIED Source · 23
Refraction within ±1.00 D efficacy	12 months	310 eyes	98.7%	306 / 310 eyes	VERIFIED Source · 24
Lost at least 2 lines of CDVA safety	12 months	310 eyes	0%	0 / 311 eyes	VERIFIED Source · 21

Complications

No structured complication observations are available for this arm. This means “not reported in this dataset,” not zero complications.

Study design

Prospective, single-arm, multicenter, unmasked study at 5 U.S. sites with 12 months of follow-up.

Country: United States
Publication-reported places: Not reported
Multicenter: Yes
Prospective: Yes
Randomized: No
Source type: FDA PIVOTAL
Regulator: FDA

Place metadata may refer to a treatment site, institution or author affiliation. Confirm its role in the linked publication.

Limitations and notes

Regulatory clinical-study report. One eye per treated subject was included; values preserve the FDA effectiveness or safety denominator reported at each visit.

Missing fields are not interpreted as negative findings. Arm counts may not be additive in all study designs.

Study evidence level
A simple, non-GRADE hierarchy based on design: randomized and large regulatory trials are high; prospective cohorts moderate; retrospective observational studies low. Manual review can override this label.