Incidence of Intraoperative and Early Postoperative Adverse Events in a Large Cohort of Consecutive Refractive Lens Exchange Procedures

Evidence database / Studies / schallhorn-2019-rle-adverse-events

10,206enrolled patients*

18,689enrolled eyes*

1structured arms

271maximum 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

Consecutive primary RLE cohort

RLE

Population

Patients: 10206
Eyes: 18689
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
Primary refractive lens exchange performed between July 1, 2014 and June 30, 2016 for refractive indications in eyes with clear lenses or mild lens changes and corrected distance acuity no worse than 20/40.

Exclusion
Not structured

Reported outcomes by follow-up

Outcome	Follow-up	Follow-up sample	Result	Reported fraction	Provenance
Post-ICL endophthalmitis complications	Mean 8.9 months	18689 eyes	0.005%	1 / 18689 eyes	VERIFIED Source · Table 2

Complications

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

Study design

Retrospective electronic-medical-record review of consecutive primary RLE procedures performed from July 2014 through June 2016, with prespecified adverse-event definitions and mandatory adverse-event recording.

Country: United Kingdom and Ireland
Publication-reported places: Nine Optical Express surgical centers in the United Kingdom and Ireland
Multicenter: Yes
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 cohort included clear lens extraction in the absence of cataract or mild lens changes with corrected acuity no worse than 20/40. Mean follow-up was 8.9 months (range 1 week to 36 months); 46.8% attended at least 12 months. Intracameral cefuroxime was used unless contraindicated. The single endophthalmitis case had permanent corrected-vision loss from 20/25 to 20/50.

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.