A randomized clinical trial comparing prompt photodynamic therapy with 3 months observation in patients with acute central serous chorioretinopathy with central macular leakage

Abstract

Purpose: The purpose of the study was to demonstrate whether photodynamic therapy in patients with acute central serous chorioretinopathy, with the leakage point within one optic disk diameter from the fovea, can be safely deferred. Methods: A single-center, randomized, controlled trial was conducted. Patients were randomized to photodynamic therapy within a week after presentation (Group I, 26 patients) or observation during 3 months (Group II, 26 patients). If leakage or subretinal fluid was observed during any control visit, photodynamic therapy was performed (again) within a week. Primary outcome: Primary outcome was change of visual acuity (Early Treatment Diabetic Retinopathy Study) after 12 months. Secondary outcomes were visual acuity, central foveal thickness, metamorphopsia, and color discrimination. Results: Photodynamic therapy procedures: group I, 26 at baseline, 2 retreatments at 3 months; group II, 10 at 3 months, 1 at 6 months (2 subjects refusing treatment), 2 retreatments at 6 months. At 12 months, mean visual acuity of all patients had improved by 6.5 letters (P < 0.001), mean central foveal thickness was 172 µm less (P < 0.001). After photodynamic therapy, visual acuity recovered faster and metamorphopsia significantly improved (3 months, P < 0.001). Differences between groups at 12 months were not significant. Conclusion: The (intended) number of photodynamic therapy (re)treatments in group II (n = 15) was 46% less than in group I (n = 28). Visual acuity and central foveal thickness at 12 months were similar. Therefore, the preferred management of acute central serous chorioretinopathy at presentation appears to be observation for 3 months.