Evaluating the Efficacy and Safety of Topical Difluprednate in Patients with Chronic Central Serous Chorioretinopathy.
rct · Level II
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- Also identified by DOI 10.1097/IAE.0000000000004943.
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Abstract
To evaluate the efficacy and safety of topical Difluprednate ophthalmic emulsion 0.05% in chronic Central Serous Chorioretinopathy (cCSCR) and compare its outcomes with oral eplerenone and observation. This pilot open-label randomised controlled trial included patients with cCSCR of ≥3 months' duration or relapsing cases with subfoveal or juxtafoveal leakage on angiography. After baseline assessment, patients were randomised into three groups: topical Difluprednate, oral Eplerenone, or observation. All participants were followed monthly for 3 months. Changes in best-corrected visual acuity, optical coherence tomography parameters, retinal sensitivity, and adverse events were documented. 53 adults (mean age 42.6 ± 9.5 years; 90.6% male) were enrolled. Complete resolution of subretinal fluid occurred in 90% (n=18) of the patients in the Difluprednate Group, 45% (n=9) in Eplerenone Group, and 23% (n=3) patients in the control arm (p < 0.001). The difluprednate group showed significantly greater reductions in subfoveal choroidal thickness (SFCT) and improvements in 3-mm microperimetry thresholds compared with the observation group (p = 0.012 and p = 0.022, respectively). It also demonstrated the largest decrease in central macular thickness, although this was not statistically significant (p = 0.19). Ocular hypertension developed in 30% of difluprednate-treated eyes and was controlled with topical antiglaucoma medication. Topical difluprednate produced superior anatomical and functional improvements in SRF resolution, SFCT reduction, and retinal sensitivity within 3-mm when compared with oral eplerenone and observation. Thus, with a manageable safety profile, it may serve as an effective therapeutic option for cCSCR.