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Edward B Moss, Stephanie A.W. Low, Darana Yuen, Yvonne M Buys, Graham Eric Trope; The effect of inhaled corticosteroids on intraocular pressure in patients with ocular hypertension or controlled glaucoma. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3712.
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This study was designed to evaluate the effect of inhaled fluticasone propionate on intraocular pressure (IOP) in patients with ocular hypertension (OHT) or controlled open-angle glaucoma (OAG). To our knowledge this potential adverse effect of steroid treatment has never been investigated using oral inhalers in a prospective, randomized, controlled trial.
This study was approved by the University Health Network Research Ethics Board. Twenty-two patients aged 18 to 85 years with OHT or stable OAG (including pseudoexfoliation, pigment dispersion, and steroid-induced glaucoma) were randomized in a double-masked fashion to a twice-daily inhaler: either 250 µg fluticasone propionate or saline placebo. Exclusion criteria included eyes with any prior incisional surgery, advanced glaucoma, or progressive/unstable disease in the previous 6 months. In the case of both eyes being eligible, the eye with poorer perimetric mean deviation was included as the study eye. There were 4 study visits: baseline, and weeks 2, 4, and 6 after starting the inhaler. Primary outcome was IOP; secondary outcomes included visual acuity, anterior segment changes, patient reported side-effects, and compliance.
To date, 22 patients have been randomized and 7 have completed the study. Two subjects withdrew after randomization, one due to personal reasons and one who developed a rhegmatogenous retinal detachment at 1 week and was subsequently removed from the study. 62% of all study visits have been completed. There was no significant change in IOP from baseline to 6 weeks (14.3±3.6 mmHg vs 14.5±4.0 mmHg, p=0.34). There was no IOP elevation ≥20% from baseline at any study visit. LogMAR visual acuity was unchanged from baseline to 6 weeks (0.23±0.12 vs 0.16±0.14, p=0.08). There were no patient-reported side-effects and all completed subjects (7/7) recorded ≥80% adherence.
Preliminary results revealed no evidence of IOP elevation after 6 weeks of twice-daily fluticasone propionate in 6 patients with OHT and/or OAG.
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