PURPOSE: To prospectively study and compare the effectiveness and the safety of primary deep sclerectomy with and without the use of mitomycin C in eyes with open-angle glaucoma. PATIENTS AND METHODS: A total of 90 eyes of 90 patients with primary open-angle glaucoma or pseudoexfoliative glaucoma underwentdeep sclerectomy. Patients were enrolled consecutively and assigned randomly to undergo deep sclerectomy without the use of mitomycin C (DS group) and deep sclerectomy with the application of mitomycin C (DSMMC group) in a concentration of 0.2 mg/mL for 2.5 minutes, before the superficial scleral flap formation. RESULTS: The intraocular pressure was significantly decreased by 7.13 mm Hg or 27.59% in the DS group and by 11.68 mm Hg or 42.25% in the DSMMC group at the end of the follow-up period. The intraocular pressure reduction in the DSMMC group was statistically significant when compared with that in the DS group (P <0.05). The complete (IOP <22 mm Hg without medication) and qualified (IOP < 22 mm Hg with or without medication) success rates at the end of the follow-up period were 42.5% and 72.5% in the DS group and 50% and 95% in the DSMMC group. The qualified success rate in the DSMMC group was statistically significant when compared with that in the DS group. Differences in complications (choroidal detachment, hyphema, leakage) seen between the two groups were statistically nonsignificant. A hemorrhagic detachment of the Descemet membrane was observed in one eye in the DSMMC group. CONCLUSIONS: The use of intraoperative mitomycin C during deep sclerectomy significantly reduced the postoperative IOP and increased the success rate of the procedure.
RCT Entities:
PURPOSE: To prospectively study and compare the effectiveness and the safety of primary deep sclerectomy with and without the use of mitomycin C in eyes with open-angle glaucoma. PATIENTS AND METHODS: A total of 90 eyes of 90 patients with primary open-angle glaucoma or pseudoexfoliative glaucoma underwent deep sclerectomy. Patients were enrolled consecutively and assigned randomly to undergo deep sclerectomy without the use of mitomycin C (DS group) and deep sclerectomy with the application of mitomycin C (DSMMC group) in a concentration of 0.2 mg/mL for 2.5 minutes, before the superficial scleral flap formation. RESULTS: The intraocular pressure was significantly decreased by 7.13 mm Hg or 27.59% in the DS group and by 11.68 mm Hg or 42.25% in the DSMMC group at the end of the follow-up period. The intraocular pressure reduction in the DSMMC group was statistically significant when compared with that in the DS group (P <0.05). The complete (IOP <22 mm Hg without medication) and qualified (IOP < 22 mm Hg with or without medication) success rates at the end of the follow-up period were 42.5% and 72.5% in the DS group and 50% and 95% in the DSMMC group. The qualified success rate in the DSMMC group was statistically significant when compared with that in the DS group. Differences in complications (choroidal detachment, hyphema, leakage) seen between the two groups were statistically nonsignificant. A hemorrhagic detachment of the Descemet membrane was observed in one eye in the DSMMC group. CONCLUSIONS: The use of intraoperative mitomycin C during deep sclerectomy significantly reduced the postoperative IOP and increased the success rate of the procedure.