Ocular Evidence
Evidence database / Studies / sekundo-2025-visumax-800-multicenter
HIGH evidencePROSPECTIVE COHORTVerified evidence

Keratorefractive Lenticule Extraction for Myopia and Myopic Astigmatism With the VISUMAX 800

Sekundo W, Chang JSM, Ganesh S, Hjortdal J, Wiltfang R · Journal of Refractive Surgery · 2025

Source
237enrolled patients*
473enrolled eyes*
1structured arms
180maximum 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 with VISUMAX 800

SMILEVISUMAX 800

Population

Patients
237
Eyes
473
Bilateral treatment
Not reported
Age range
Not reported
Sphere range
Not reported
Cylinder range
Not reported
Spherical equivalent
-10 to -0.25 D
Corneal thickness
Not reported

Eligibility definition

Inclusion
Myopia up to -10.00 D and astigmatism up to 5.00 D.

Exclusion
Not structured

Reported outcomes by follow-up

OutcomeFollow-upFollow-up sampleResultReported fractionProvenance
UDVA 20/20 or better
efficacy
6 months473 eyes93.2%denominator: 473 eyes
VERIFIED
MRSE within ±0.50 D
predictability
6 months473 eyes95.1%denominator: 473 eyes
VERIFIED
Refraction within ±1.00 D
efficacy
6 months473 eyes99.6%denominator: 473 eyes
VERIFIED
Lost at least 2 lines of CDVA
safety
6 months473 eyes0%0 / 473 eyes
VERIFIED

Complications

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