PURPOSE: To evaluate the efficacy of sodium hyaluronate eye drops for prevention of late-onset bleb leakage after trabeculectomy with mitomycin C (MMC). METHODS:Sixty-eight patients (68 eyes) who had trabeculectomy with MMC from March 1995 to February 2002 at the Marui Eye Clinic or the Department of Ophthalmology, Fukushima Medical University Hospital were examined in this study. Twenty-two were treated postoperatively with sodium hyaluronate eye drops (sodium hyaluronate group) and 46 eyes were not treated postoperatively (control group). The blebs were classified according to the avascular area, epithelial defect and degree of bleb wall leakage. Both groups were assigned classes (0, avascular or partial avascular bleb; 1, avascular or partial avascular bleb with an epithelial defect; 2, avascular or partial avascular bleb with oozing; 3, avascular or partial avascular bleb with a point of leakage). RESULTS: Follow-up duration ranged from 10 to 116 months (mean+/-SD, 57.6+/-30.5). The incidence of reclassification from class 1 to class 0 was significantly greater in the sodium hyaluronate group (four of six class 1 eyes improved to class 0 after application of sodium hyaluronate eye drops) than in the control group (zero of 10 eyes) (P=0.008). And, the incidence of reclassification from class 1 to class 2 or class 3 was significantly smaller in the sodium hyaluronate group (one of six eyes) than in the control group (nine of 10 eyes) (P=0.008). CONCLUSIONS:Sodium hyaluronate eye drops may prevent late-onset bleb leakage after trabeculectomy with MMC.
RCT Entities:
PURPOSE: To evaluate the efficacy of sodium hyaluronate eye drops for prevention of late-onset bleb leakage after trabeculectomy with mitomycin C (MMC). METHODS: Sixty-eight patients (68 eyes) who had trabeculectomy with MMC from March 1995 to February 2002 at the Marui Eye Clinic or the Department of Ophthalmology, Fukushima Medical University Hospital were examined in this study. Twenty-two were treated postoperatively with sodium hyaluronate eye drops (sodium hyaluronate group) and 46 eyes were not treated postoperatively (control group). The blebs were classified according to the avascular area, epithelial defect and degree of bleb wall leakage. Both groups were assigned classes (0, avascular or partial avascular bleb; 1, avascular or partial avascular bleb with an epithelial defect; 2, avascular or partial avascular bleb with oozing; 3, avascular or partial avascular bleb with a point of leakage). RESULTS: Follow-up duration ranged from 10 to 116 months (mean+/-SD, 57.6+/-30.5). The incidence of reclassification from class 1 to class 0 was significantly greater in the sodium hyaluronate group (four of six class 1 eyes improved to class 0 after application of sodium hyaluronate eye drops) than in the control group (zero of 10 eyes) (P=0.008). And, the incidence of reclassification from class 1 to class 2 or class 3 was significantly smaller in the sodium hyaluronate group (one of six eyes) than in the control group (nine of 10 eyes) (P=0.008). CONCLUSIONS:Sodium hyaluronate eye drops may prevent late-onset bleb leakage after trabeculectomy with MMC.