Five-year outcomes of EVO implantable collamer lens implantation for the correction of high myopia and super high myopia

Evidence database / Studies / chen-2021-five-year-evo-icl-high-myopia

—enrolled patients*

—enrolled eyes*

2structured arms

1825maximum 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

High myopia

ICLEVO Implantable Collamer Lens

Population

Patients: Not reported
Eyes: Not reported
Bilateral treatment: Not reported
Age range: Not reported
Sphere range: Not reported
Cylinder range: Not reported
Spherical equivalent: -12 to -6 D
Corneal thickness: Not reported

Eligibility definition

Inclusion
Spherical equivalent from -6.00 D to -12.00 D.

Exclusion
Not structured

Reported outcomes by follow-up

Outcome	Follow-up	Follow-up sample	Result	Reported fraction	Provenance
MRSE within ±0.50 D predictability	5 years	—	60.5%	Not reported	VERIFIED Source
Refraction within ±1.00 D efficacy	5 years	—	79.1%	Not reported	VERIFIED Source
Mean postoperative spherical equivalent refractive	5 years	—	-0.67 D	Not reported	VERIFIED Source
Efficacy index efficacy	5 years	—	0.83	Not reported	VERIFIED Source
Safety index safety	5 years	—	1.03	Not reported	VERIFIED Source

Complications

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

Study arm

Super high myopia

ICLEVO Implantable Collamer Lens

Population

Patients: Not reported
Eyes: Not reported
Bilateral treatment: Not reported
Age range: Not reported
Sphere range: Not reported
Cylinder range: Not reported
Spherical equivalent: Not reported
Corneal thickness: Not reported

Eligibility definition

Inclusion
Spherical equivalent worse than -12.00 D.

Exclusion
Not structured

Reported outcomes by follow-up

Outcome	Follow-up	Follow-up sample	Result	Reported fraction	Provenance
MRSE within ±0.50 D predictability	5 years	—	22.5%	Not reported	VERIFIED Source
Refraction within ±1.00 D efficacy	5 years	—	47.5%	Not reported	VERIFIED Source
Mean postoperative spherical equivalent refractive	5 years	—	-1.74 D	Not reported	VERIFIED Source
Efficacy index efficacy	5 years	—	0.86	Not reported	VERIFIED Source
Safety index safety	5 years	—	1.32	Not reported	VERIFIED Source

Complications

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

Study design

Prospective cohort with high-myopia and super-high-myopia strata followed for five years.

Country: China
Publication-reported places: Not reported
Multicenter: Not reported
Prospective: Yes
Randomized: No
Source type: PROSPECTIVE COHORT
Regulator: Not reported

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

Limitations and notes

The source reports 83 eyes in 46 patients overall but does not state arm denominators in the abstract; percentages were retained without inferred denominators.

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.