Prevalence and Risk Factors of Ocular Hypertension Following Fluocinolone Acetonide (Iluvien®) Intravitreal Injections: The "SAFAC" Study.

INTRODUCTION

The aim of this real-life study was to analyze the prevalence and risk factors of ocular hypertension (OHT) after fluocinolone acetonide implant (FAc-I) intravitreal injections in the treatment of macular edema of various etiologies.

METHODS

This retrospective, monocentric study included all consecutive patients with ≥ 1 FAc-I injection. The primary endpoint was the occurrence of OHT, defined as intraocular pressure (IOP) of at least 25 mmHg and/or an increase ≥ 10 mmHg from baseline.

RESULTS

A total of 171 eyes of 127 patients were injected with FAc-I for diabetic macular edema (61.4%), post-surgical macular edema (19.9%), uveitis (11.1%), and retinal vein occlusion or radiation maculopathy (7.6%). The prevalence of OHT after FAc-I injections was 24.6% (n = 42) and did not differ among groups according to disease (p = 0.943). In most cases, OHT was successfully treated with topical medication alone (14% of the whole cohort, n = 24, 57% of the hypertonic cases). Selective laser trabeculoplasty (SLT) was used in 12 eyes (7.0%). The rate of incisional IOP-lowering surgery was 3.5% (n = 6). In multivariable analysis, risk factors for OHT included younger age (p = 0.036) and pre-existing OHT or glaucoma (p = 0.034). The positive predictive value for the absence of OHT after DEX-I injections was 80.4%.

CONCLUSIONS

OHT occurred in approximately one in four eyes after FAc-I injection and was commonly and successfully treated with topical treatment alone or SLT in 95% of the hypertonic cases (40/42). Risk factors for OHT after FAc-I included younger age and pre-existing OHT or glaucoma. Uveitis and retinal vein occlusion were not risk factors for OHT. Previous DEX-I injection seems to be a useful predictive test. Therefore, regular IOP monitoring is essential for all patients receiving FAc-I injections, especially those with risk factors for OHT.