Long-term incidence and risk factors of ocular hypertension following Dexamethasone-implant injections. The SAFODEX-2 study

Purpose To analyze the incidence, risk factors and time to onset of ocular hypertension (OHT) after intravitreal injections (IVI) of Dexamethasone implant (DEX-I) and to evaluate the long-term cumulative probability of intraocular pressure elevation. Methods Eyes of patients having received at least one DEX-I IVI between October 2010 and February 2015 were included in the present study. OHT was defined as IOP > 25 mmHg and/or an increase of 10 mmHg over the follow-up period compared with baseline IOP. Results 494 eyes were studied in 410 patients. For a total of 1,371 IVI, the incidence of OHT was 32.6% in the study eyes with a mean follow-up period of 30 months (3-62.5) and a median follow-up of 29 months. Pressure-lowering treatment was introduced for 36.9% of eyes. Topical treatment alone was sufficient to manage OHT in 97%. Young age, male sex, uveitis and retinal vein occlusion (RVO), glaucoma treated with a double or triple-combination topical pressure-lowering medication were found to be risk factors for OHT. The incidence of OHT did not change with an increase in the number of IVI, and there was no cumulative effect, defining by an increase of the incidence of OHT in patients after repeated IVI (p=0.248). Conclusion This study confirmed that OHT is of moderate incidence, transient, controlled by topical treatment and provides data on the long-term cumulative probability of IOP elevation in a large cohort of eyes treated with DEX-I IVI. Repeat injections of DEX-I neither increase nor decrease the risk of OHT.