Incidence of Ectasia After SMILE From a High-Volume Refractive Surgery Center in India

Evidence database / Studies / brar-2021-smile-ectasia-incidence-india

—enrolled patients*

6,619enrolled 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

Standard SMILE cohort

SMILE

Population

Patients: Not reported
Eyes: 6619
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
Eyes undergoing standard SMILE with a minimum follow-up of 12 months.

Exclusion
SMILE Xtra eyes were excluded from this standard-SMILE incidence denominator.

Reported outcomes by follow-up

Outcome	Follow-up	Follow-up sample	Result	Reported fraction	Provenance
Post-LASIK corneal ectasia complications	At least 12 months	6619 eyes	0.15%	10 / 6619 eyes	VERIFIED Source · Abstract

Complications

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

Study design

Retrospective analysis of eyes undergoing SMILE or SMILE Xtra from November 2012 through August 2019; only eyes with at least 12 months of follow-up were included.

Country: India
Publication-reported places: Nethradhama Super Speciality Eye Hospital, Bengaluru
Multicenter: No
Prospective: No
Randomized: No
Source type: RETROSPECTIVE
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 overall standard-SMILE result was 10 ectasia cases among 6,619 eyes, with mean ectasia onset at 21.3 months. Eight of the 10 ectatic eyes were retrospectively classified as borderline and two had normal preoperative topography. Device model was not entered because it was not specified in the reviewed abstract.

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.