Ocular Evidence
Evidence database / Studies / parkhurst-2025-three-year-fda-evo-icl
HIGH evidenceFDA POST APPROVALVerified evidence

Three Year Results from the United States FDA Prospective Multicenter Clinical Study of the EVO/EVO+ Implantable Collamer Lens

Parkhurst G, Brinton JP, Faulkner A, Moshirfar M, Kugler LJ, Stahl JE, Zavodni Z, Thompson VM, Price FW, Wiley WF, Aronsky M, Whitman JD, Solomon JD, Perkins SA, Packer M, Egamino J · Clinical Ophthalmology · 2025

Source
327enrolled patients*
629enrolled eyes*
1structured arms
1095maximum 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

EVO/EVO+ ICL

ICLEVO Implantable Collamer Lens

Population

Patients
327
Eyes
629
Bilateral treatment
Not reported
Age range
Not reported
Sphere range
Not reported
Cylinder range
Not reported
Spherical equivalent
-15.62 to -3 D
Corneal thickness
Not reported

Eligibility definition

Inclusion
Age 21 to 45 years; moderate to high myopia with astigmatism up to 4.00 D.

Exclusion
Not structured

Reported outcomes by follow-up

OutcomeFollow-upFollow-up sampleResultReported fractionProvenance
MRSE within ±0.50 D
predictability
3 years629 eyes90.7%denominator: 629 eyes
VERIFIED
Refraction within ±1.00 D
efficacy
3 years629 eyes99.0%denominator: 629 eyes
VERIFIED
Mean postoperative spherical equivalent
refractive
3 years629 eyes-0.12 DNot reported
VERIFIED
Gained 1 or more lines of corrected visual acuity
safety
3 years629 eyes48.9%denominator: 629 eyes
VERIFIED
Lens exchange rate
complications
3 years629 eyes0.32%2 / 629 eyes
VERIFIED
Anterior subcapsular cataract rate
complications
3 years629 eyes0.16%1 / 629 eyes
VERIFIED

Complications

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